Dimension Troubleshooting Guide

Dimension®
DC
Troubleshooting Guide
Chemistry
Chemistry Troubleshooting Guide
© Siemens, 2014
10444832
10444826
10636929
10463360
© Siemens, 2014
- Restricted - All documents may only be used
by authorized personnel for rendering services
on Siemens Healthcare Products. Any docu-
Susan Robbins
Siemens
ment in electronic form may be printed once.
Copy and distribution of electronic documents
and hardcopies is prohibited. Offenders will be
liable for damages. All other rights are reserved.
Print No.: DCIN-B01.840.02.01.02 English

Replaces: n.a. Doc. Gen. Date: 10.14
n.a.
Part No.: 2014
H DX GPS D
2 Copyright / Version / Disclaimer
1Copyright / Version / Disclaimer
Copyright
“© Siemens, 2014“ refers to the copyright of a Siemens entity such as Siemens Aktienge-
sellschaft - Germany, Siemens Shenzhen Magnetic Resonance Ltd. - China, Siemens
Shanghai Medical Equipment Ltd. - China, Siemens Medical Solutions USA Inc. - USA,
Siemens Healthcare Diagnostics Inc. - USA and/or Siemens Healthcare Diagnostics Prod-
ucts GmbH - Germany.
Document Version
Siemens reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents corre-
spond to the version at the time of system delivery and/or printout. Versions to hardcopy
documentation are not automatically distributed. Please contact your local Siemens office
to order current version or refer to our website http://www.healthcare.siemens.com.
Disclaimer
Siemens provides this documentation “as is“ without the assumption of any liability under
any theory of law.
The service of equipment described herein is to be performed by qualified personnel who
are employed by Siemens or one of its affiliates or who are otherwise authorized by Sie-
mens or one of its affiliates to provide such services.
Assemblers and other persons who are not employed by or otherwise directly affiliated with
or authorized by Siemens or one of its affiliates are not entitled to use this documentation
without prior written authority.
Dimension® DCIN-B01.840.02.01.02 Page 2 of 390 © Siemens, 2014

10.14 H DX GPS D Restricted
Table of Contents 3
0Table of Contents
1________ Preface ________________________________________________________ 14
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
How to Use this Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Carryover Pairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Method Timing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Result Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Result Monitor Maintenance Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
The Result Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Result Monitor Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2________ A Methods _____________________________________________________ 28
ABS (DF79) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Method Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Method Specifics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
ACP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
ACTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
AHDL (DF48B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
ALB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
ALDL (Direct LDL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
ALP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
© Siemens, 2014 DCIN-B01.840.02.01.02 Page 3 of 390 Dimension®

Restricted 10.14 H DX GPS D
4 Table of Contents
ALPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Result Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Troubleshooting (Tips to Resolve Potential Accuracy and Precision) . . . . . . . . . . . . 49
ALT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
ALTI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
AMON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
AMPH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
AMY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
AST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
AUD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
For BUN, CREA, PHOS, URCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
For EZCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
3 _______ B Methods_____________________________________________________ 73
BARB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
BENZ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
BNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Table of Contents 5
BUN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4________ C Methods _____________________________________________________ 86
C3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
C4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
CCRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
CHK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
About CHK Flex Reagent Cartridge (DF179) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
CHOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Method Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Method Specifics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
CKI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
COC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
CRBM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

6 Table of Contents
CREA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
CRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
CSA (HM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Error Messages and Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
CSAE (HM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Errors and Message Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
CTNI/ LTNI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Result Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
5 _______ D Methods____________________________________________________ 135
DBI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
DGNA (HM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
DGNA (Non-HM). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
DGTX (HM). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
DGTX (Non-HM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
6 _______ E Methods____________________________________________________ 148
ECO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Table of Contents 7

ETOH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
EXTC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
EZCR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
EZCR is an Auto Urine Dilution (AUD) Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
EZCR Flex® Wells 1 and 2 Contain HCI at 0.5N Concentration . . . . . . . . . . . . . . . 159
Calculations Associated with EZCR Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
7________ F Methods ____________________________________________________ 162
FERR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
FPSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
FT3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
FT4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
FT4L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
8________ G Methods ____________________________________________________ 188
GENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

8 Table of Contents
GGT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
GLUC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
9 _______ H Methods____________________________________________________ 197
HB1C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
HCG/ LHCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
HIL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
10 ______ I Methods ____________________________________________________ 213
IBCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
IGA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
IGG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
IGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
IRON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224

Table of Contents 9
11_______ L Methods ____________________________________________________ 226
LA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
LDI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
LI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
LIDO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234
LIPL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
12_______ M Methods ____________________________________________________ 241
MALB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
MBI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
METH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
MG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
MMB/LMMB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

10 Table of Contents
MPAT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
MYO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
13 ______ N Methods____________________________________________________ 263
NAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Result Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
NTP/LNTP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269
14 ______ O Methods ___________________________________________________ 274
OPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
15 ______ P Methods____________________________________________________ 277
PALB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
PBNP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
PCHE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
PCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
PHNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299

Table of Contents 11

PHOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
PROC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
PTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311
16_______ R Methods ____________________________________________________ 313
RCRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
17_______ S Methods ____________________________________________________ 315
SAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315
SIRO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
18_______ T Methods ____________________________________________________ 319
T4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319
Method Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 319
TACR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
TBI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Measurement Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326

12 Table of Contents
High Intercept After Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

Open Well Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
TGL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 328
THC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
THEO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
TNI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336
TOBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
TP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344
TPSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346
TRNF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
TSH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351
TSHL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
TU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 369

Table of Contents 13
19_______ U Methods ____________________________________________________ 371
UCFP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 371
URCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373
20_______ V Methods ____________________________________________________ 375
VALP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 375
VANC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 377
21_______ Service Methods _______________________________________________ 380
DABS/DCHK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382
HABS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385
RIMS/RMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386
W1BS/W2BS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 388
22_______ List of Hazard IDs ______________________________________________ 390

14 Preface
1-
Introduction
1Preface
This chemistry troubleshooting guide provides information to assist you in troubleshooting

all Dimension® clinical chemistry systems.
This guide is for use by trained Siemens personnel only. Siemens does not authorize
any other use.
In order to troubleshoot method chemistry problems on a Dimension® system, you should
be familiar with the following steps involved in method processing on the instrument.
• Cuvette formation, one or two cuvettes per method.
• Reagent or sample probe wash.
• Reagent delivery to the cuvette, with or without mix.
• Sample delivery to the cuvette, with mix.
• Photometer read with primary and secondary optical filters.
• Photometric reads captured in the filterdata files.
Filter data provides valuable information. You can often determine the step that caused an
error by comparing good and erroneous filterdata.
The method processing steps in this guide are taken from the current method database,
method Instructions for Use (IFU) and Dimension® service manuals.

Preface 15
How to Use this Guide 1.1
This guide is presented in sections, one section per method. The first item in each section
is a table describing method processing events in a condensed format. When using these
tables, keep the following in mind:
• The initial “cuvette QC” or “air blank” photometer reads are not listed as the first event
for every method because they are the same in every case.
• Reagent arm 1 (R1ARM) and Reagent arm 2 (R2ARM) deliver reagent components
(R1, R2, R3 or R4) to the cuvette. The components are listed in the order they are deliv-
ered, with the water chase (H2O) listed last.
• In the method parameter/database the components are listed in the order they are
delivered to the cuvette with the water chase (H2O) listed last.
• The PHOT READ measures the cuvette’s absorbance with primary and secondary opti-
cal filters.
• A method may use one or two cuvettes. Activities for both cuvettes are described.
• Reagent addition with ultrasonic mix is labeled YES (Y). If there is no mix, it is labeled
NO (N).
• The sample probe adds sample with water chase (H2O) volume to the cuvette, which is
then ultrasonically mixed.
• Type ‘a’ methods have one R1ARM delivery (single or double dip) to cuvette.
• Type ‘b’ methods have one R1ARM delivery and one R2ARM delivery to cuvette.
• Type ‘c’ methods have one R1ARM delivery and multiple R2ARM deliveries or two
cuvettes.

16 Preface
Carryover Pairs 1.2
If the OPTIMIZE TIME TO RESULT option is set, the system will also reorder any test pairs
that may negatively impact one another, for example, due to potential carryover. The reor-
dering is done only if the tests are immediately paired, the technique is to simply swap
places.
The following is a list of carryover pairs programmed in the software:
ACTM/ IBCT EZCR/ ADHL PCHE/ PHOS

ALCI/ AMON EZCR/ ACTM PTN/ PHOS
ALC/ UCFP EZCR/ PHOS PTN/ UCFP
ALP/ MG EZCR/ TP THEO/ PHOS
ALT/ LDH EZCR/ ALDL TP/ IBCT
ALTI/ LDI LA/ LDH TP/ TBI
AST/ LDH LDH/ ETOH TP/ TBIL
CA/ IBCT LDI/ AST TU/ BARB
CK/ MG LDI/ ALT UCFP/ TBI
CRP/ PHOS LDI/ ALTI UCFP/ TBIL
ETOH/ UCFP LDI/ LA
EZCR/ CHOL LIPL/ CA
NOTE Although LDI/ AST; LD/ ALT; LDI/ ALTI and LDI/ LA are listed
in MethPar as carryover pairs, internal studies have shown
that running these pairs present no adverse carryover
effects.
Example 0
A sample that includes both PTN and UCFP tests. Assume there were no tests longer than
PTN on this sample. Sorting by longest time would result in PTN, UCFP...followed by the
remaining tests. The system would then check for carryover pair methods and find the PTN/
UCFP pair. PTN and UCFP would swap places, leaving the UCFP as the first assay sam-
pled to minimize potential carryover from the PTN.

Preface 17
Method Timing 1.3
Dimension® clinical chemistry system throughput depends on the number of different tests
ordered in a profile. First time to result is usually 7 to 8 minutes on a Chem7 profile. User
defined (open channel) assays may diminish throughput. An open channel method pro-
cessing time of <440 seconds will not affect the throughput. The Dimension® clinical chem-
istry system method processing times in minutes are shown in the following table. The
timings are calculated based on the difference between air-tag - final PHOTO read. An
additional 7.4 seconds added if the method uses a two-cuvette scheme or scheduled delay
as written in the MethPar.
Tab. 1 Dimension® Clinical Chemistry Method Parameter Timings
Method Non-HM Methods HM Methods EXL LOCI

MethPar times MethPar Times Methods(min.)
(min.) (min.)
ACP 9.9
ACTM 7.5
AHDL 8.7
ALB 3.3
LC 3.3
ALDL 4.9
ALP 6.9
ALPI 8.4
ALT 6.6
ALTI 6.6
AMON 8.8
AMPH 6.5
AMY 4.7
AST 6.6
BARB 6.0
BENZ 6.0
BNP 10.0
BUN 3.3
C3 8.4
C4 8.4

18 Preface

(min.) (min.)
CA 2.3
CCRP 18.0
CHOL 7.5
CKI 8.7
COC 6.0
CRMB 8.2
CREA 2.2
CRP 3.2
CSA 9.8
CSAE 9.8
CTNI/ LTNI 15.4
DBI 5.8
DBIL 5.8
DGNA 8.1 8.4
DGTX 8.8 8.1
ECO2 2.2
EZCR 8.7
ETOH 4.6
EXTC 6.2
FERR 19.9
FPSA 19.8
FT3 18.5
FT4 19.9
FT4L 12.0
GENT 7.8
GGT 3.0
GLUC 3.2

Preface 19

(min.) (min.)
HA1C 8.8
HB1C 8.8
HCG/ LHCG 14.1
HIL 2.2
IBCT 6.5
IGA 8.7
IGG 8.7
IGM 8.7
IRON 6.9
LA 12.2
LDI 7.5
LI 3.4
LIDO 8.2
MALB 6.2
MBI 8.7
METH 4.2
MG 3.4
MMB/ LMMB 9.9
MYO 14.1
NAPA 7.4
NTP/LNTP 14.0
OPI 6.0
PALB 6.2
PBNP/ LPBN mono 18.1
PCHE 6.0
PCP 6.0
PHNO 8.6

20 Preface

(min.) (min.)
PHOS 6.9
PROC 7.4
PTN 5.5
RCRP 5.1
SAIR 1.0
SAL 2.7
SIRO 19
T4 7.0
TACR 14.7
TBI 8.7
TBIL 8.7
TGL 8.2
THC 6.0
THEO 5.9
TNI 10.1
TOBR 8.8
TP 8.7
TPSA 19.8
TRNF 8.4
TSH 18.8
TSHL 15.9
TU 5.9
UCFP 3.4
URCA 6.3
VALP 8.4
VANC 8.7

Preface 21
Result Monitor 1.4
General Information 0
The Result Monitoring feature uses existing photometric reads to check for the expected
delivery of reagents and sample (for some methods). The Abnormal Assay error message
is reported if the expected, or calculated absorbance is not met for a specific sample.
This feature is user-programmable and can be activated for methods on Dimension® for
which method-specific limits have been established. Periodically, Siemens may communi-
cate deviations to the limits. Each calculated absorbance “result” is collected by method
and reagent lot, and is then used to set the baseline and establish instrument specific limits
for that reagent lot. Accumulated results are stored for two lots per method.
The Result Monitor screen in software is available to allow the user to adjust method-spe-
cific limits and to view the instrument-specific limits that have been calculated. This screen
is the user’s interface to the reagent QC database information. The ability to change limits
is password-protected. The reagent QC database is set up to accumulate either one or two
sets of absorbance results for each method which are used to generate the Abnormal
Assay error flag. The Result Monitor screen displays these two sets of data, limits, and
results, for each method as either the “A” monitor or the “B” monitor. The method parameter
database refers to the “A” monitor as Reagent QC-1, and the “B” monitor as Reagent QC-2.
Result monitoring information unique to a specific sample can be found in the “rgqc” section
(under Polished Results section) of the filter data for that result. “A” monitor information is
listed under the “primary” column, while “B” monitor information is listed under the “second-
ary” column in the filter data. The first line of the “rgqc” section indicates whether or not the
limits were exceeded for that specific result by displaying any of the following:
• na- not available (errors are not reported)
• ok- within established range
• hi or lo- outside the established range
If both “A” and “B” monitors are employed by that method, then the A condition is posted
first, followed by B’s condition, separated by a comma. See Figure 1 below.
NOTE When the Abnormal Assay flag is generated for any result,
this line/section in filter data is the only way to determine
whether it was the “A” monitor or the “B” monitor that gen-
erated the error. This information is often critical for trouble-
shooting the error.
General Troubleshooting 0
Steps for collecting information to understand the source of the Abnormal Assay flag are:
1. Rerun the same sample.

22 Preface
2. If the same error occurs, run a QC sample for that method.

3. If the error continues on the QC sample, remove, confirm and reenter the Flex® onto
the instrument, and rerun the QC sample. This will “zero” the suspect reagent Flex®
well.
These three steps help to isolate the cause, using the following decision tree:
Step 1 determines if the error is repeatable. If the error does not recur, the likely cause
would be a one-time event. Use the method-specific troubleshooting chart to further isolate
the source. If the error remains when the sample is rerun, move to step 2.
Step 2 is taken only if the error repeats. Running a QC sample will test if the error is due
to the sample itself. If the error does not repeat on the QC sample, a possible cause may
be a lipemic, icteric or hemolysed sample. Review the Filter Data. If the error remains on
the QC sample, move to step 3.
Step 3 is taken only when the error persists for different samples. Removing the flex from
inventory and reentering will cause the instrument to move to a fresh set of reagent wells.
If the error does not repeat on the fresh well set, the cause may be a problem with the spe-
cific wells, such as a poor hydration, diluted or partially filled wells.
If the “abnormal assay” error persists, check the Chemistry Troubleshooting Guide for
method specific information.
Result Monitor Maintenance Alert 0
Result Monitor Maintenance Alert is a result monitor function that facilitates result monitor
flagging based on the absolute deviation of a current result monitor value (as calculated in
a methpar) from its associated mean. The absolute deviation is the value entered into the
Above and Below Mean Factor on the Result Monitor Limits screen. The flag does not man-
ifest itself as an error that prevents a patient result from being reported, but rather as a
warning under the status boxes on the Dimension® screen, signaling that maintenance is
required to maintain optimal performance of the instrument.
An example of the use of this alert is the monitoring of blank values for CTNI, TSH and
PBNP. Once a blank value exceeds the mean of the previous blank values by an absolute
amount, an error triggers a minor error that is posted in the error log with the mnemonic of
the method producing the error (from the Operating Menu, press F5: PROCESS CTRL, F6:
ERROR LOG). In the case of HM cascade, blank monitoring, the minor error text is speci-
fied as follows: HM Result Monitor Maintenance Alert, press F5 for instructions.
The help instructions provide the appropriate maintenance and troubleshooting steps.
The Result Monitoring Screen 0
The information on the Result Monitoring screen in the Dimension® system software ver-
sions containing this feature is divided into three sections. The top section, METHOD, is
used to select the specific method. The left-hand section, LIMITS, shows fields that can be
edited by the operator. The right-hand section, ACCUMULATED RESULTS, shows the sta-
tus of the Result Monitoring feature for the selected method.

Preface 23
METHOD Section
The method field will display one of the 34 methods with the available Result Monitoring
feature. The Next Method key pages through all 34 methods. Pressing the individual
method keys also will bring up the method, if available.
LIMITS Fields
These fields may show either an A, or an A and a B column, dependent upon whether the
method uses one or both monitoring checks. The fields in each column define the Limits,
using either percentage limits or SD limits. Above Mean Factor numbers are given as per-
centage factors of the mean absorbance result. For example, an upper limit of 1.20 indi-
cates that the flag will be triggered if an individual result monitor “result” is greater than
120% of the mean. A lower limit of 0.75 indicates a limit triggered at 75% of the mean. For
the Mean Plus/Minus SD fields, the number entered is the factor times the SD to define
the limit around the mean. For example, a Mean Plus/Minus SD factor of 6 indicates that
the limits are 6 SD's above and below the mean absorbance value.
Select only Above/Below Mean Factor or SD option. If both limits are entered, the SD lim-
its will be applied.
ACCUMULATED RESULTS Fields

The Reagent Lot ID field displays active lots on the instrument. To view accumulated results
for a second reagent lot, use the F2 key to switch lots. The Status field shows whether the
feature is actively checking results, or collecting initial baseline data. The Monitor columns
display the mean, SD, lower and upper limits around the mean, as well the number of
results checked and flagged. The results count does not begin until the baseline data are
accumulated. Refer to Table 2: Result Monitor Summary for n(min) for minimum tests
required for active status.
ZERO DATA Feature

Major software or hardware changes may cause an increase in Abnormal Assay flags. If
there is no other cause for this increase, you should use the zero data feature to perma-
nently delete all accumulated results for a specific method. A new baseline will be set and
the nuisance flags eliminated. If the zero data feature is used, the accumulated results
should be deleted for BOTH reagent lots on board. Table 2 (Result Monitor Summary) lists
optical filters used to generate each flag and the minimum number of tests that will re-acti-
vate the flag. This is useful in deciding which methods may need the baseline reset when
an optical filter is replaced, since the analytical wavelength is not always the same as the
abnormal assay wavelength for a given method.
To delete the accumulated results for a specific reagent lot:
(Assuming that you have activated the Result Monitor feature for the method.)
1. Go to the Result Monitor screen for the method.

2. Press F4: Zero Data.
3. At the prompt, type in your system password and press Enter.

24 Preface
4. Answer the prompt “Do you want to delete all data from this screen (y/n)” by typing
the letter y.
5. Press F2: Other Lot and repeat steps 2 – 4.
All accumulated results information on the screen will be set to zero for these reagent lots.
The result monitor feature will begin accumulating new results to establish a new baseline.
NOTE The error flag uses absolute limits when status is setting
baseline. Refer to the n(min) column in the Result Monitor
Summary Table for minimum number of results required for
each method to change error flagging status back to Active.
NOTE Do not change or adjust limits before consulting with Global

Product Support (GPS) for their recommendations. If you
want to adjust factors on the Limits side of the screen: move
the cursor to the field, type the limit, press the Enter key, and
then press F8: Store Parameters.
Result Monitor Summary 0
Method Result Rgt/Smp Report Above Below SDLi n(min n(ma abs low abs Analy
Moni- Error Mean Mean mit ) x) high Wave
tor Factor Factor lengt
ACP A reagent yes 1.25 0.80 20 250 0.0 2000.0 600/7
B reagent yes 1.25 0.80 20 250 0.0 2000.0 600/7
ALDL A reagent yes 1.30 0.70 20 250 0.0 2000.0 540/7
ALP A reagent yes 1.80 0.60 60 250 0.0 2000.0 405/5
ALPI A reagent yes 1.80 0.60 15 250 0.0 2000.0 405/5
B reagent no 0.00 0.00 15 250 0.0 2000.0 405/5
ALT A reagent yes 1.30 0.75 60 250 0.0 2000.0 340/7
B sample no 0.00 0.00 60 250 0.0 2000.0 340/7
ALTI A reagent yes 1.30 0.75 60 250 0.0 2000.0 340/7
B sample no 0.00 0.00 60 250 0.0 2000.0 340/7
AMON A reagent yes 1.15 0.75 20 100 0.0 2000.0 340/3
B reagent yes 1.25 0.50 20 100 0.0 2000.0 340/3

Preface 25
Method Result Rgt/Smp Report Above Below SDLi n(min n(ma abs low abs A
Moni- Error Mean Mean mit ) x) high W
tor Factor Factor le
AST A reagent yes 1.20 0.75 60 250 0.0 2000.0 34
B sample no 0.00 0.00 60 250 0.0 2000.0 34
BUN A reagent yes 1.08 0.80** 80 250 0.0 2000.0 34
CA A regent yes 5 60 250 0.0 2000.0 57
B reagent yes 1.07 0.97 60 250 0.0 2000.0 57
CRP A Pb1 yes 1.20 0.80 30 250 300.0 1000.0 34
B Pb2 yes 1.20 0.80 30 250 300.0 1000.0 34
CCRP* A cro2 chk yes 1.25 0.65 15 250 45.0 200.0 40
B reagent yes 1.10 0.75 15 250 35.0 400.0 40
CREA A reagent yes 2.00 0.80 80 250 0.0 2000.0 51
B reagent yes 1.00 1.00 80 250 0.0 2001.0 51
CSA* A reagent yes 1.20 0.80 10 250 50.0 400.0 57
B cro2 chk yes 2.00 0.40 10 250 35.0 200.0 57
CSAE* A reagent yes 1.20 0.90 5 250 45.2 371.4 57
B reagent yes 1.10 0.80 5 250 80.0 160.0 57
CTNI/ A relative yes 1.19 0.83 15 250 80.0 300.0 51
LTNI* (cro2)
B absolute yes 40.00*** 0.00 15 250 2.0 130.0 51
(blank)***
DBIL A reagent yes 1.10 0.80 20 100 0.0 2000.0 54
B sample yes 3.00 0.20 20 100 0.0 2000.0 54
ECO2 A reagent yes 1.12 0.88 30 250 600.0 1200.0 40
B reag/sam yes 2.00 0.10 45 250 10.0 54.0 40
p
EZCR A reag/sam yes 1.20 0.80 56 250 0.0 2000.0 54
p
FPSA A cro2 chk yes 1.20 0.80 15 250 50.0 150.0 57
FT4* A reagent yes 1.13 0.87 15 250 0.0 2000.0 51
GGT A reagent yes 3.50 0.50 80 250 0.0 650.0 40

26 Preface
Method Result Rgt/Smp Report Above Below SDLi n(min n(ma abs low abs Analy
Moni- Error Mean Mean mit ) x) high Wave
tor Factor Factor lengt
GLUC A reagent yes 1.20 0.85 20 250 0.0 2000.0 340/3
B sample yes 1.02 0.96 20 250 90.0 110.0 340/3
HA1C A air blank yes 1.50 0.85 20 250 0.0 2000.0 340/4
0
B Hb mAu yes 1.15 0.80 30 250 0.0 2000.0 340/4
ratio 0
HB1C A air blank yes 1.50 0.85 20 250 0.0 2000.0 340/4
0
B Hb mAu yes 1.15 0.80 30 250 0.0 2000.0 340/4
ratio 0
HIL A sample yes 2.50 0.60 10 250 100.0 2000.0 293/4
2/700
LI A reagent yes 1.18 0.82 30 250 600.0 1200.0 540/7
LIDO A reagent yes 1.50 0.50 20 250 300.0 1200.0 340/7
LIPL A reagent yes 1.50 0.50 60 250 0.0 2000.0 577/7
MALB A reag/sam yes 4.00 0.50 20 250 250.0 800.0 340/7
p
MG A reagent yes 10 30 250 0.0 2000.0 600/5
B sample no 2.00 0.85 60 250 0.0 2000.0 600/5
MPO A cro2 yes 1.25 0.65 15 250 25.0 200.0 577/7
B CPRG yes 2.00 0.50 15 250 50.0 500.0 577/7
MYO* A reagent yes 1.20 0.80 15 250 0.0 2000.0 577/7
NAPA A reagent yes 1.50 0.50 40 250 150.0 1000.0 340/7
B reagent yes 1.50 0.50 50 250 0.0 80.0 340/7
PALB A reagent yes 1.05 0.95 30 250 0.0 2000.0 383/7
PBNP/ A relative yes 1.40 0.80 45 250 40.0 200.0 510/7
LPBN* (cro2)
B absolute yes 40.00*** 0.00 30 250 2.0 130.0 510/7
(blank)***

Preface 27
Method Result Rgt/Smp Report Above Below SDLi n(min n(ma abs low abs A
Moni- Error Mean Mean mit ) x) high W
tor Factor Factor le
PHOS A reagent yes 1.20 0.75 60 250 0.0 2000.0 34
B icterus no 0.00 0.00 10 250 0.0 2000.0 34
flag
PROC A reagent yes 1.50 0.50 40 250 150.0 1000.0 34
B reagent yes 1.50 0.50 50 250 0.0 80.0 34
PTN A reagent yes 7 28 250 0.0 2000.0 34
RCRP A reagent yes 1.20 0.80 30 250 300.0 1000.0 34
B reagent yes 1.20 0.80 30 250 300.0 1000.0 34
SIRO* A reagent yes 1.20 0.80 10 250 50.0 400.0 57
B cro2 chk yes 2.00 0.40 10 250 35.0 200.0 57
TACR* A reagent yes 1.20 0.80 10 250 50.0 400.0 57
B cro2 chk yes 2.00 0.40 10 250 35.0 200.0 57
TGL A reagent yes 1.50 0.80 50 250 0.0 250.0 51
TP A reagent yes 10 80 250 0.0 2000.0 54
B icterus no 0.00 0.00 10 250 800.0 2000.0 54
flag
TPSA* A cro2 chk yes 1.20 0.80 10 250 50.0 150.0 57
TSH* A relative yes 0.19 0.83 15 250 0.0 135.0 51
(cro2)
B absolute no 40.0*** 0.00 15 250 2.0 100.0 51
(blank)***
Notes:
ACP/AMON/RCRP result monitor “A” calculated from first cuvette, “B” calculated from second cuvette
CTNI/LTNI/FT4 HM method
HA1C/MG result monitor “A” and “B” calculated from second cuvette
*HM method
**BUN Below Mean Factor 0.80 recommended
***CTNI, LTNI, PBNP, LPBN, TSH result monitor “B” uses an absolute (blank) factor defined as the mean of the B
in the “above mean factor” column

28 A Methods
2-
ABS (DF79)
2A Methods
(System Check All Dimension® Models)
Method Chemistry 0
(SABS)
Event # Event Delivery Volumes/ Filters Mix

1 R1ARM (R1) 0 µL (H20) 345 µL Y
2 PHOT READ 510/405 nm
3 SAMPLE (CO2S04) 5 µL (H20) 50 µL Y
4 PHOT READ 510/ 405 nm
Total Cuvette Volume: 400 µL
First Cuvette (R1BS)

1 R1ARM (R1) 60 µL (H20) 420 µL Y
Second Cuvette (R2BS/ PQC)

1 PHOT READ All Wavelengths
3 R2ARM (R2) 60 µL (H20) 420 µL Y
Total Cuvette volume: 480 µL
Method Specifics 0
• Endpoint, bichromatic, 510/ 405 nm.

A Methods 29
• Type ‘c’ method.

• There is no “three cuvette” method, so a system check schedules 5 “SABS” assays
(first 5 cuvettes). It then schedules the “ABS” method, which is essentially a “two
cuvette” method which alternates between “R1BS” and the “R2BS” assay. Two blank
reads on the “R2BS” cuvette prior to any fluid deliveries are used for the PQC test for all
ten wavelengths. As with the original system check, only the highest PQC result of the 5
cuvettes read will be printed on the report slip. This results in 5 “SABS” cuvettes in a
row, followed by 10 “reagent” test cuvettes, alternating R1BS and R2BS respectively.
This only holds true if there are no dirty windows or bad cuvettes (all scheduled win-
dows are used-none skipped).
• Third-party reagent companies distribute ABS reagent cartridges for use by Dimen-
sion® customers. When troubleshooting System Check failures or other ABS-associ-
ated issues, verify that the ABS is Siemens. Siemens does NOT support non-Siemens
ABS reagent.
• Put up: 30 tests per Flex®
5/5/5/5/5/5
cobalt sulfate
• ABS Flex® reagent cartridge usage:
Instrument Type New Reagent Cartridge Number of System Checks

Test Count In Inventory Per Reagent Cartridge
Dimension® RxL (non-HM), 15 3
Xpand® (non-HM)
Dimension® RxL HM, 10 2
RxL HM/RMS,
Xpand® HM,
EXL w/LM and EXL 200,
Xpand Plus
• RxL with HM and RMS using 15 out of 30 tests in the reagent cartridge or 1 out of 2 sys-
tem checks:
- 10 tests will display (2 system checks)
- Uses 5 systems- R1, R2, Sampler, HM wash, RMS = 5 system tests
- R1 = 5 tests
- R2 = 5 tests
- HM and RMS use the same well = 5 tests
- Sampler uses ABS in cup.

30 A Methods
• ABS Flex® wells 1, 2, 4, and 5 contain 635 µL cobalt sulfate. Wells 3 and 6 contain 981
µL cobalt sulfate. The additional volume is used by R3 of RMS module (RIMS) if the
instrument is equipped with RMS optional reagent storage unit.
Troubleshooting 0
ABS
NOTE In addition to the following troubleshooting tips on “System

Check,” refer to the Dimension® RxL Operators Guide, Sec-
tion 5 for basic information.
“System Check” tests are chemistry free performance checks of critical fluid movement and
photometric electromechanical instrument components. The performance checks are
made using a dye solution of cobalt sulfate to eliminate any reactive variables. Four sub-
systems are checked on all instruments except for RxL’s equipped with either an HM and/
or RMS Module, both of which require additional subsystem tests by the System Check
routine. These tests are identified and defined as follows:
• Photometer (PQC): Photometer drift QC stability test.
Specs: Wavelength drift limited to ±1.5 mAU for all wavelengths except for the 293 nm
wavelength whose limit is ±2.5 mAU.
• Reagent #1 (R1BS): Checks accuracy and precision of the reagent pumps.
Specs: Assay value listed on the end flap of the ABS cartons ±12 mAU.
Specs: Assay value listed on the end flap of the ABS cartons ±12 mAU.
• Sampler (SABS): Checks accuracy and precision of the sample pumps.
Specs: Mean = 10% of the assay value listed on the end flap of the ABS carton ±2mAU.
• W1BS and W2BS: Refer to W1BS and W2BS service methods.
• RMS: Refer to RIMS/RMS service method.
Keyboard System Check Map, useful for scheduling independent SC tests:
• DABS: <SHIFT + P9>
• RIMS: <SHIFT + P10>
• HABS: <CTRL + F1>
• R1BS: <CTRL + F2>
• SABS: <CTRL + F3>
• PQC: <CTRL +F5>
• W1BS: <ALT + GGT> with HM Module.

A Methods 31
• W2BS: <ALT + GLUC> with HM Module.

Troubleshoot first any Photometer System Check failures before troubleshooting any other
coincidental System Check problems. Photometric performance is primary to all other Sys-
tem Check tests and must be performing normally before correcting other problems.
NOTE Typically System Check performance will be better than

specification by a factor of two or better. Atypical perfor-
mance near specification limits is not desirable and should
not be tolerated as it usually indicates an incipient problem.
PQC
PQC problems result from excessive variation between two blank photometer reads for the
same optical filter on a specific cuvette. The reads take place approximately 43 seconds
apart and generally indicate how well the photometer can reposition itself back to the cen-
ter of a specific cuvette window after movement to another window.
• Dirty cuvette windows.
• Cuvette wheel misalignment.
• Defective or malformed cuvettes.
• Defective, aged or incorrectly installed source lamp.
• Defective or dirty optical filter(s).
• Photometer misalignment.
• Thermal chamber insulation interference.
• Cuvette film not routed correctly through either film guide.
• Defective cuvette film.
• Foreign material stuck in the beam path (often the red film attachment adhesive tape).
• Photometer drive belt tension too loose or too tight.
• Damaged photometer drive belt.
• Photometer belt toothed gear ring loose on photometer casting.
• Photometer belt holding set curves from pulleys (replace or reposition belt to fix).
• “D” washer interference with log amp.
• Log amp mounted too high.
• Excessive cuvette film tension drag, which pulls cuvettes backward after a cuvette
wheel index.
• Cable interference and tension.
• Photometer bearing needing lubrication.
• Loose optics in photometer (need additional wavy washer).
• Photometer offset alignment off by one count (software).

32 A Methods
• Loose capstan drum on the cuvette film drive motor.
R1BS/ R2BS
Accuracy
• Cuvette wheel/windows, log amp.
• Wrong coefficients.
• C-Term correction required.
• Incorrect test solution.
• Wrong Bottle Value entered for ABS lot.
Precision
• Fluidics, cuvette quality, ultrasonics.
• Loose tubing or tubing fittings.
• Defective syringes.
• Crimped or pinched tubing.
• Defective cuvettes.
• Overflowing wash drains.
• Worn reagent probe tip.
• Defective pump panel valve(s).
• Poor Ultrasonic mix.
• External fluid, usually probe wash water or reagent tube condensate water, leaking into
cuvettes through the baseplate cuvette probe access holes.
SABS
Ensure R1BS is functioning properly.
Accuracy
• Wrong ABS sample.
• Evaporated sample being reused.
• Wrong carton value.
• Wrong Flex® lot.
Precision
• R1 arm delivers 345µL of water to cuvette and mixes. If R1 is not perpendicular to
cuvette, ultrasonic mixing can cause foaming.
• Misaligned sample probe.
• Worn sample probe.
• Loss of chase water or sample to sample drain.

A Methods 33
ACP 2.1
Method Chemistry 0
First Cuvette (test)

1 R1ARM (R1) 280 µL N
2 SAMPLE 24 µL, (H20) 40 µL Y
3 R2ARM (R2) 36 µL, (H20) 20 µL Y
Second Cuvette (blank)

1 R1ARM (R2) 36 µL, (R1) 280 µL, (H20) 20 µL Y
Method Specifics 0
• Endpoint, bichromatic 600/700 nm.

• Flex® type = 6 well.
• Two-cuvette method: blank removes serum interferences.
• Methodology = adaptation of thymolphthalein monophosphate (TMP) hydrolysis.
• Verified method.
• No reagent hydration QC.
Troubleshooting 0
• Check theoretical coefficients: C0 = -0.200, C1 = 0.880

34 A Methods
• Sensitive to R2 probe-to-cuvette alignment and R2 probe mix.

• ACP is extremely unstable. Serum samples should be run immediately after collection
when possible. If this is not possible, the sample must be stabilized with an acid. QC
product should be handled the same way, otherwise, you will get low results. Refer to
the insert sheet for further details.
• The ACP in serum is stabilized by the addition of citric acid tablets.
• Long R2 delivery time and long PHOT READ times. Instrument throughput will be
reduced when R2 delivery time is greater than 244 seconds and photometer read times
are greater than 454 seconds.
Tab. 2 Limit Table
Rslt Optical Mini- Maxi- Above Below Error Status

Mntr Filters mum mum Mean Mean Mes-
Reps Reps Factor Factor sage
A 510/700 20 250 1.25 0.80 abnl Active
assay
B 510/700 20 250 1.25 0.80 abnl Active
assay
Tab. 3 Method Specific Troubleshooting
Method Monitoring Information Troubleshooting

ACP A on first cuvette with sample Check for TMP/Citrate delivery by
Final read(r2), air blanked R1ARM
Endpoint 510/700 for reagent Check Wells 1-3 for tablet hydration
Analytical at 600/700
Mean 350 mA ± 40 τψπιχαλ
Limits are mean +25% or –20%
B on second cuvette, reagent blank (with sam- Check for TMP/Citrate delivery by
ple) R1ARM
Final read (r2), air blanked Check Wells 1-3 for tablet hydration
Endpoint 510/700 for reagent
Analytical 600/700

A Methods 35
ACTM 2.2
Method Chemistry 0
First Cuvette (blank)

1 R1ARM (R1) 0µL, (H2O) 150 µL N
2 SAMPLE 4 µL, (H20) 16µL Y
4 R2ARM (R2) 80µL, (R3) 80 µL, (H20) 100 µL Y
Second Cuvette (sample)

1 R1ARM (R1) 80µL, (H20) 70 µL N
4 R2ARM (R2) 80 µL, (R3) 80 µL, (H2O) 100 µL Y
Method Specifics 0
• Endpoint, bichromatic 600/ 700 nm.

• Flex® type = 6 well, all liquid reagents.
• Calibration type: linear.
• Five unit negative bias verus Abbott TDx® due to calibrator differences.
• If customer changes the assay range of 300 µg/mL, the suggested autodilute volume of
2 µL cannot be used. False-elevated ACTM results may be obtained.

36 A Methods
• Extremely elevated QC results if calibration is performed using the wrong calibrator lev-
els.
• Water is not a recommended diluent for manual dilutions. For manual dilutions, use
DDRUGC II level 1 or ACTM-free serum.
• Bio-Rad Drug-Free Serum shows a false positive recovery of approximately 4 to 6
µg/mL
Troubleshooting 0
Abnormal Reaction
Check1_700>50 mAU.
Check1_700>200 mAU.
Root Cause:
• R2 probe misaligned or worn.
• Reagent mixing inadequate due to R2 probe ultrasonics.
Abnormal Reaction
C1_Sample<100 mAU.
C2_Sample<150 mAU.
This error occurs when the value of the 293nm - 700nm result is less than 100 mAU for the
blank cuvette, or less than 150 mAU for the sample cuvette.
Root cause:
• Insufficient or no sample in cup.
• Insufficient sample aspiration due to crimped sample tubing.
• Sample probe misaligned or worn.
• Water tested as a linearity sample.
• Sample has low protein concentration (especially QC products).
Below Assay Range

ACTM concentration below assay range.
Perform a 50% recovery of known standard or QC material to confirm there was no activity
in the sample, and that there was no instrument malfunction.
If the calculated sample concentration confirms the concentration to be <2.0 µg/ mL, the
result should be reported as “less than 2.0 µg/ mL.”

A Methods 37
Above Assay Range

ACTM concentration above assay range.
Dilute sample with ACTM-free serum or DDRUGCII level 1, enter dilution factor.
Assay Range Diluted

The sample was autodiluted but the result still exceeded the assay range.
Dilute sample wiht ACTM-free serum or DDRUGCII level 1, enter dilution factor.
Within-Run Precision
Root cause:
• R2 Probe misaligned.
• R2 Probe worn.
• Cuvette windows dirty.
Within-Lot Accuracy
Root cause:
• Calibration drift.
• Incorrect handling of QC material.
• QC material deterioration.
• Photometric issues.

38 A Methods
AHDL (DF48B) 2.3
Method Chemistry 0
First Cuvette (probe wash)

1 R1ARM (R3) 150µL, (H2O) 100 µL N
2 SAMPLE (S) 0µL, (H20), 24 µL Y
3 R2ARM (R3) 50 µL, (H2O) 100 µL N
Second Cuvette (test)

1 R1ARM (R1) 300µL, (H20) 25µL N
2 SAMPLE (S) 3µL, (H20) 22 µL Y
4 R2ARM (R2) 100 µL, (H2O) 20 µL Y
Method Specifics 0

• AHDL is a two-cuvette method. The purpose of the first cuvette is to wash the sample
and reagent probes. The second cuvette is the reaction cuvette.
• Lipemia interference is less than 10% at triglyceride concentrations below 1150 mg/dL
(13.0 mmol/L). Do not calculate the LDL value when the triglyceride level is greater than
400 mg/dL (4.52 mmol/L) because the LDL calculation is invalid at higher triglyceride
levels.
• Two 700 checks are performed to assess foaming that may occur in the cuvette during
sample processing.

A Methods 39
• This method has been evaluated by and meets the certification acceptance criteria of
the Cholesterol Reference Method Laboratory Network (CRMLN). The method’s accu-
racy is referenced to the Abell-Kendall Designated Comparison Method (DCM). Certifi-
cation is performed every two years. A copy of the certificate is available in DMS.
• The National Cholesterol Education Program (NCEP) has established standards for the
precision, accuracy and total allowable error when comparing the method to the DCM.
Precision
• %CV ≤ 4% if HDL-C is greater than 40 mg/dL [1.04 mmol/L].
• Standard Deviation <1.7 mg/dL [0.44 mmol/L] if HDL-C is less than 40 mg/dL [1.04
mmol/L].
Accuracy (bias)
• %Bias ≤ 5%.
Total Error
• ≤ 13%.
Troubleshooting 0
Abnormal Reaction
The fixed foam error limits (check700>100 or check2_700>100) indicate foaming in the
reaction cuvette following reagent 2 addition and reagent 1/sample addition, respectively).
The Abnormal Reaction rest report message may be observed with extremely lipemic sam-
ples due to the spectral interference of such samples.
Inaccuracy
Potential causes of inaccuracy include:
• Shorter sample.
• Improper QC or PT peer group. AHDL (DF48B) uses separate peer groups than AHDL
(DF48A).
• Improper sample storage: longer than 7 days refrigerated or 3 months frozen.
• Improper calibration.
- Not pressing the calculate function key.
- Using the incorrect calibrator product.
- Improper calibrator values.
- Shelf life of AHDL (DC48B) Calibrator is 6 months from date of manufacture.
• Improper shipping or storage fo Flex® reagent cartridges or calibrators.

40 A Methods
• Operator Errors, including sample mix up, missing sample or missing Flex® reagent
cartridge.
Imprecision
Potential causes of imprecision include:
• Misaligned or worn sample or reagent probes.
• Poor ultrasonic mixing of sample or reagent 2 probe.

A Methods 41
ALB 2.4
Method Chemistry 0

1 R1ARM (R1) 125 µL, (H2O) 305 µL N
3 PHOT READ 540/600/700 nm
Total Cuvette Volume: 500 µL.
Method Specifics 0
• Endpoint, polychromatic 540/ 600/ 700 nm (Allen Correction).

• Type ‘a’ method.
• Flex type = 6 well, all liquid reagents.
• The albumin method (bromocresol purple methodology) is specific for human albumin;
BCP does not bind to globulins and therefore will not falsely overestimate values.
• QC Product with non-human base will recover lower values.
• TP-ALB calibrator revised to expand coverage of the assay range.
• Systematic bias between BCP albumin vs. BCG albumin.
• Color is stable; read time is not critical.
• Analytical method timing = 3.28 min
Troubleshooting 0
• Sensitive to amount of dissolved oxygen in the water. Insufficient oxygen (less than 5
ppm) in water will cause imprecision due to poor sample mix. Water temperature and
Millipore vacuum affect this.
• Sensitive to sample mix.
• No sample mix will give lower results by 50%.

42 A Methods
• Falsely low values may be caused by:

- Presence of CMPF (3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid).
- Delamination of 600 nm filter (usually in instruments older than 2 years).
- Improper hydration of level 3 calibrator.
- Poor nutrition, such as in nursing home patients. Run prealbumin as a confirmation
test.
- Veterniary samples- ALB uses a BCP method which does not bind globulins and is
therefore not appropriate for veterinary samples.
• Within-lot accuracy shifts.
- Worn R1 probe.
- Dried reagent on underside of reagent lid tray.
- Pinched or yellowed R1 tubing.
- Improper handling of QC.

A Methods 43
ALDL (Direct LDL) 2.5
Method Chemistry 0

1 R1ARM (R1) 300 µL, (H2O) 40 µL Y
5 R2ARM R2 100 µL, (H2O) 20 µL Y
Method Specifics 0

• Type ‘b’ method.
• Flex® type = 6 well; 10 tests/ well-set, all liquid reagents, wells 1-3 have pre-incubation
reagent (R1), wells 4-5 have detection reagent (R2).
• Autodilute volume = 2.0 µL.
• Lower Limit of Detection (LLD) is 5 mg/dL. Refer to Flex® insert sheet.
Troubleshooting 0
Result Monitor
• Result Monitor for ALDL checks for accurate delivery of Reagent 1. An “abnormal
assay” flag indicates short delivery of Reagent 1 and reduced reaction volume that
could result in a falsely elevated ALDL result.

44 A Methods
• The result monitor function does not become activated until 20 ALDL values have been
generated with a new lot of Flex® reagent. ALDL values may come from calibrators,
controls or patient samples. In addition, the rolling mean of the result monitor values
turns over after 250 results have been collected.
Tab. 4 Limit Table

Reps. Reps. Factor Factor sage
A 340/700 20 250 1.30 0.7 abnl Active
assay
Tab. 5 Result Monitor Method Specific Troubleshooting

ALDL A Reagent Blank Check R1 pre-incubation reagent
Endpoint (r2), air blanked delivery by R1ARM.
Bichromatic (340/700) Short delivery of Reagent 1 (R1)

would result in significantly different
Limits: Mean +30% or -30% reagent blank (rgBlank) value and an
abnormal assay (abnl assay) mes-
sage would be printed in the report
slip. The first detergent present in
the R1 reagent is responsible for
digestion and elimination of choles-
terol in the HDL and VLDL fractions.
Inadequate R1 reagent could allow
carryover of HDL and VLDL choles-
terol, falsely elevating LDL choles-
terol values.
What is the likely cause of an “abnormal assay” flag in the ALDL method?
• Short delivery of Reagent 1 (R1) would result in significantly different reagent blank
(rgBlank) value and an abnormal assay (abnl assay) message would be printed on the
report slip. The first detergent present in the R1 reagent is responsible for digestion and
elimination of cholesterol in the HDL and VLDL fractions. Inadequate R1 reagent could
allow carryover of HDL and VLDL cholesterol, thereby falsely elevating the LDL choles-
terol values.
• Result Monitor “A” value is calculated as:
RgBlank = (r2[340] - r1[340]) - (r2[700] - r1[700])

A Methods 45
What is the likely cause of a “measurement error” flag in the ALDL method?
• This is a timing error and is generated if for some reason the “r3” read occurs after 217
seconds. It is intended to flag the result where the “r3” read takes place after the deliv-
ery of R2 reagent, which occurs at 220 seconds. In this situation, the sample should be
retested and the result without the error flag should be reported.
What is the likely cause of an “abnormal reaction or foam error” flag in the ALDL
method?
• Foam error is generated in the presence of foaming where:
Check 2_700 (Reagent 1 and sample): r3[700] - r1[700] > 100
Check 3_700 (reagent 1 and Reagent 2 and sample): r4[700] - r1[700] > 100
What are possible causes of imprecision and inaccuracy in the ALDL method?
Calibration
• Vial Rehydration/ Low: Customer does not add sufficient quantity of water to reconsti-
tute the calibrator vials correctly. Calibrator concentration high, patient samples report
low.
• Vial Rehydration/ High: Customer adds too much water during reconstitution step. Cali-
brator concentration low, patient samples report high.
Reagent
• Reagent may have been compromised during shipping or storage.
• Inaccurate reagent volumes.
Instrument
• Imprecise delivery of Reagent 1 and 2.
• Inaccurate mixing (Ultrasonic).
• Imprecise delivery of sample (Sample Probe).
• Inaccurate Photometric system (source lamp, filters, cuvettes).

46 A Methods
ALP 2.6
Method Chemistry 0

1 R1ARM (R2) 45 µL, (R1) 14 µL, (H2O) 106 µL N
3 R2ARM (R3) 45 µL, (H2O) 50 µL Y
Method Specifics 0
• Rate, bichromatic 405/ 510 nm.

• Methodology = p-NPP, AMP buffer.
Troubleshooting 0
• Check theoretical coefficients: C0 = -6.000; C1 = 5.540

• QC products will perform well on Dimension® if the source of ALP is human, porcine, or
bovine kidney (not intestine).
• Temperature drift within thermal chamber (>0.8°) may cause QC shifts.
• Results increase over time on samples and QC that are left standing at room tempera-
ture or refrigerated at 4°C.
• See CSB# D-0033 for documenting and troubleshooting QC shifts.
• ALP was revised for Dimension® to add air gap between R1 and R2 reagents during
first reagent addition (R1ARM). This was done to prevent MG from precipitating out
while in the reagent tubing and causing carryover to MG method. Use “optimize time to
result” feature to eliminate unfriendly carryover pair with MG. Look for air gap in R1 tub-
ing during 1st reagent addition. Leaks in tubing or reagent probe/ nut can cause prob-
lems in this area. R2 tubing and R2 probe tip are critical, since they deliver the reagent
(R3) that initiates the reaction.

A Methods 47
• No reagent mix will produce elevated results by approximately 30U/L.

• Method is temperature sensitive; rate of reaction increases with rise in temperature and
vice versa.
• Open wells absorb TCO2. Ths may lower AMP buffer pH.
• A shift in AMP buffer pH may shift QC. Human samples have greater resistance to pH
shifts.
• As a general rule, it is best to analyze ALP specimens the same day they are drawn.
• ALP is often interpreted as “abnormal” because of the use of inappropriate reference
ranges by the laboratory.
• If the P-NPP tablets are exposed to light more than 3.5 hours, the tablets will turn bright
yellow and give high “A” errors (FOD_LIMIT).
• If lot-to-lot QC shift is observed, perform a crossover study using 5-10 human samples.
Result Monitor
Tab. 6 Limit Table

A 405/510 60 250 1.8 0.6 abnl Active
assay

ALP A on sample and reagents Check for PNPP delivery by R2ARM
Back extrapolated air blanked Check wells 1-3 for tablet hydration
At analytical 405/510
Mean 400 mA ± 40 typical
Limits are mean +20% or -40%
reagent

48 A Methods
ALPI 2.7
Method Chemistry 0

1 R1ARM (R1) 90µL, (H2O) 176 µL N
3 R2ARM (R2) 57 µL, (H2O) 20 µL Y
Method Specifics 0

• Calibrated with ALPI CAL (DC150) traceable to IFCC Reference Method
• All wells contain liquid reagents
• Methodology = p-NPP, AMP buffer.
Result Monitor 0
Tab. 7 Limit Table

A 405/510 15 250 1.25 0.6 abnl Active
assay

A Methods 49
Tab. 8 Problem/Cause/Action Table
Problem Cause Action

Abnor- Abnormal assay is generated when the Check reagent probe align-
mal Rg1Blank (RM A) is outside the limits. ments and fluidics. Some
Assay Rg1Blank represents the absorbance reading highly icteric samples may
(Result of AMP, sample and pNPP. generate high readings.
Monitor
A)
Rg1Blank = (mau2-mau1) - Time [r2]-225 *
Srate
Readings will vary based on the sample. Typ-
ically Cal 1 will have a Rgt1 Blank reading of
approx 250 mau; Cal 3 could be up to 490
mau. These numbers could be different from
lot to lot.
Both of these numbers can get low or high
depending on what reagent is low (AMP or
pNPP) pr what sample is in the reaction
cuvette. Typically mau numbers for patients
and QC would be approximately 250 - 350.
Abnor- Rg2 Blank (RM B) which is mau2 = r2[405] - No limits assigned and not
mal r2[51-] will be different at every level. This has activated.
Assay AMP, sample and pNPP. There are no
(Result assigned limits for RM B.
Monitor
B)
Troubleshooting (Tips to Resolve Potential Accuracy and Precision) 0
Problems with the ALPI Method

• Basic accuracy and precision troubleshooting should start with checking the R1, Sam-
ple and R2 probe alignments followed by tubings and drain maintenance
• For accuracy problems - check sample integrity, calibrators / calibration especially after
major maintenance or part replacement.
• For precision problems - check alignments, ultrasonics, fluidics
Troubleshooting Quality Control and Lot to Lot Variation

• Enzyme methods such as alkaline phosphatase are sensitive to small changes in
reagent composition such as pH and ionic strength.

50 A Methods
• Reagent composition is constant within a Flex® lot but can change slightly between
Flex® lots, within strict manufacturing tolerances. It is important to keep this in mind
when establishing quality control limits.
• Siemens recommends using at least three to five different reagent lots when establish-
ing quality control limits. When investigating lot to lot variation consider the following:
- The stability of alkaline phosphatase in the Quality Control product should be consid-
ered and verified in the QC IFUs.
- Most commercial quality control materials contain non-human enzymes and a
non-human matrix which can cause them to behave differently from human
enzymes.
- Quality control samples typically have a different pH optimum than calibrators and
patient samples.
- Quality control matrix is often responsible when the performance of quality control
samples is not consistent with a particular reagent lot.
- When a quality control matrix is suspected, patient samples may be used between
lots to determine if reagent differences affect patient results; patient results are not
compromised since the ALPI reagents are optimized for human serum.
- Matrix bias is almost certainly responsible for quality control discrepancies if human
samples demonstrate comparable performance.
When human serum/plasma samples are processed between reagent lots, results are
expected to be clinically equivalent. However, if patient samples also show clinically signif-
icant discrepancies between reagent lots, the reagent and/or calibrator performance
should be questioned.
Troubleshooting 0
The conditions that influence the ALPI activities are:

• Reaction temperature
• Reaction pH

A Methods 51
• Conditions of sample, sample matrix

Tab. 9 Problem/Cause/Action Table
Problem Cause Action

Calibration is outside Incorrect bottle values; Verify calibrator bottle val-
acceptable limits. switched calibrators; sam- ues and correct calibrators
Acceptable slope is 0.97 - ple probe not properly in the sample cups.
1.03; intercept should be aligned.
clinically insignificant (<10 Imprecision between repli-
U/L); correlation coefficient cates.
(r) is 0.990 - 1.000.
Absorbance FOD-test>1150=FOD-error Check reagent probe align-
[Absorbance] ments and fluidics
The mAU at measurement
wavelength exceeded 1150
Abnormal Reaction Criteria: Check 1 700>30 -
Foam error [Abnormal
Reaction]
Falsely elevated or A slight variation in reaction Make sure the thermal
decreased ALPI results temperature may cause the chamber is latched all the
reaction pH to shift. way up. Sample drain, the
As the reaction temperature instrument tubing, or
decreases, the reaction pH cuvette film at the film guide
will increase resulting in may be interfering with
lower ALPI results. complete closure of the
thermal chamber. There
Elevated temperature will should be no vertical play of
increase ALPI results. thermal chamber after
latching.

52 A Methods
ALT 2.8
Method Chemistry 0

1 R1ARM (R1) 30 µL, (H2O) 110 µL N
3 R2ARM (R2) 80 µL, (H2O) 50 µL Y
Method Specifics 0

• Methodology = P5P, pyruvate>lactate.
• Intra-Flex® transfer during hydration. Hydrations are done by 2500 µL syringe for wells
4-6. Hydration QC volume is 7 µL for wells 1-3; and 18 µL for wells 4-6.
• Reagent QC is susceptible to problems in fluid delivery performance.
Troubleshooting 0
• Check theoretical coefficients:

C0 = +3.000; C1 = -3.375 (standard volume)
C0 = -5.000; C1 = -5.950 (reduced volume)
• Sensitive to thermal chamber air flow.
• Sensitive to foaming due to low total cuvette volume and low dead volume in wells. ALT
is a “low dip” (into the cuvette) method which is sensitive to R2 probe height alignment.
A recent tubing change (customer maintenance) may inadvertently change vertical
sensor position on the “top hat” (sensor mount). R2 arm mounting screw torque can
create different probe heights in different areas of the baseplate. Use diagnostics
“bump routine” to verify probe-to-cuvette height at 3-4 points on the baseplate.

A Methods 53
• R2 reagent mix sensitive.

• Sensitive to R2 probe tip wear.
• High outliers may be caused by a clogged R2 drain overflowing into the cuvette.
• Sensitive to 340/ 700 filters delaminating.
• Large “C1” term makes it susceptible to noisy filter wheel motor. New filter wheel motor
may help. Check PQC and photometer troubleshooting technical bulletins DAR-96 and
DAR-120.
Tab. 10 Limit Table

A 340/700 60 250 1.3 0.75 abnl Active
assay
B 293/700 60 250 0.0 0.0 abnl Not
assay Active

ALT A on sample and reagents Check for NADH delivery by R1ARM
Back extrapolated from r2, r3 Check wells 1-3 for tablet hydration
B on sample and reagents Detects lack of 35 µL sample delivery
Reagent QC2 calculation: Endpoint r1, air
blanked, bichromatic (293/700), checks for
sample addition
Disabled since autodilute trips this

54 A Methods
ALTI 2.9
Method Chemistry 0

1 R1ARM (R1) 30 µL, (H2O) 110 µL N
3 R2ARM (R2) 80 µL, (H2O) 50 µL Y
Method Specifics 0
• Rate, bichromatic 340/700 nm.

• Methodology = P5P, pyruvate>lactate. Same tableted reagents as ALT (DF43A).
• Calibrated method – uses Enzyme II Calibrator (ENZII Cal, Cat. No. DC143)
• Assay Range: 6-1000 U/L (0.10-16.70 µkat/L)
• Intra-Flex® transfer during hydration. Hydrations are done by 2500 µL syringe for wells
4-6. Hydration QC volume is 7 µL for wells 1-3; and 18 µL for wells 4-6.
• Reagent QC is susceptible to problems in fluid delivery performance.
Troubleshooting 0
• Continuous cuvette method – added in SW 10.0 and higher

- In SW 10.0 the Dimension® instrument will have the continuous cuvette command
feature. This will allow the Dimension instrument to measure ALTI from the same
location on the cuvette wheel for every ALTI test. This will improve consistency of
results and prevent instrument temperature fluctuations in the cuvette wheel from
affecting the ALTI results.

A Methods 55
• Sensitive to foaming due to low total cuvette volume and low dead volume in wells. ALTI
is a “low dip” (into the cuvette) method which is sensitive to R2 probe height alignment.
A recent tubing change (customer maintenance) may inadvertently change vertical
sensor position on the “top hat” (sensor mount). R2 arm mounting screw torque can
create different probe heights in different areas of the baseplate. Use diagnostics
“bump routine” to verify probe-to-cuvette height at 3-4 points on the baseplate.
• Sensitive to 340/700 filters delaminating.
DAR-120.
Tab. 12 Limit Table

A 340/700 60 250 1.3 0.75 abnl Active
assay
B 293/700 60 250 0.0 0.0 abnl Not
assay Active

ALTI A on sample and reagents Check for NADH delivery by R1ARM
Back extrapolated from r2, r3 Check Wells 1-3 for tablet hydration
sample addition

56 A Methods
AMON 2.10
Method Chemistry 0

1 R1ARM (R1) 155 µL, (H2O) 32 µL N
3 R2ARM (R2) 50 µL, (H2O) 30 µL Y

1 R1ARM (R1) 155 µL, (H2O) 32 µL N
3 R2ARM (R2) 50 µL, (H2O) 30 µL Y
Method Specifics 0

• Samples for AMON should be placed on ice immediately after being drawn and spun in
a refrigerated centrifuge; the plasma should also be separated, placed on ice and run
within 20 minutes.
• Sample contamination is possible if exposed to vapors from ammonia cleaning agents.
• AMON is very susceptible to foaming which can cause low or negative outliers.

A Methods 57
• Sensitive to R2 mix (too much) R2 probe-to-cuvette alignment affects R2 mix. check

R2-arm to cuvette alignment at 0, 18, and 38.
• Check cuvette to baseplate alignment. If it is off to one side, try to favor reagent probe to
cuvette to that side or adjust cuvette ring followed by photometer realignment.
• Water bottle is contaminated, results depressed.
• Ensure reagent tubing is clean and cable does not pull reagent probe to one side on dis-
pense or mix. Use reagent diagnostics.
• AMON precision is generally not outstanding at the low end. This is due maily to the low
signal, two-cuvette set-up and mixing problems. Protein samples are better than aque-
ous.
• As sample volume decreases, results go negative and then in the absence of sample
you get 25 µmol/L.
• 1 mau = 25 µmol/L.
• If ALC is previous reagent, can cause high or low outliers depending on whether blank
or test cuvette gets contaminated.
• Poor cuvette formation can contribute to imprecise results. Airflow to cuvette manufac-
turing should be near 4-9 L/min.
• Some lots of MAS ALC/ AMON QC can cause open well instability due to differences in
the buffering capacities of these controls.
• Carryover pairs: ALC, AMON.
Troubleshooting 0
Thermal Chamber Air Flow

• The Dimension® RxL has reduced (improved) air flow. The amount of air forced out
across the top of the cuvettes during the reaction is reduced. The thermal chamber
blower fan on the RxL has only one side, with a solid plate covering the air opening at
the bottom of the chamber. This controls the amount of air allowed into the bottom of the
thermal chamber.
• Be sure there is a good seal between thermal chamber and baseplate.
Reagent 2 ARM/ Probe Positioning

• The Reagent 2 arm belt drive should be checked for center cuvette positioning if there
are signs of overmixing, or foaming, in the cuvette. Attempt to retrieve filterdata on
imprecise results. Filter data may show signs of foaming. Use ELECTROMECHANI-
CAL diagnosis and check at three different baseplate locations, e.g. 0 (sample hole), 18
(alignment guage hole), and 33 or 38 (at rear of instrument). In the reagent diagnostic
screen, select R2. Move cursor to GOTO: field. Type in the number of the baseplate
hole destination for the R2 arm and press RETURN. The R2 arm will move to the loca-
tion. Move the R2 probe down fully into the cuvette and check for centering.

58 A Methods
• Some reagent ultrasonic transducers are stonger than others. For a quick check, switch
R1 and R2 transducers. If R1 is less active, it may solve overmixing or compensate for
align variability in cuvette.
Photometric System
• Some AMON imprecision is due to loose lenses, optics, loose source lamp, or photom-
eter positioning problems. AMON is a “two cuvette” method. The first cuvette is a
“blanking” cuvette and photometric reads are used to calculate the AMON result. This is
an extra challenge for the photometric positioning system to be consistent between two
cuvettes during a single rate reaction. This adds more opportunity for positioning vari-
ability. Most other methods only challenge the photometer positioning for consistency
at one cuvette during a single reation.
Carryover Pair Issues on Dimension® AMON

• When the ACL method is scheduled before the AMON method, ammonium sulfate in
the ADH reagent for ALC can be carried over to the first cuvette (blank rate) of AMON,
thereby reducing the expected results. The carryover involves both the R1 reagent arm
probe and the sample arm probe.
To minimize this carryover problem, ALC/ AMON was designated as a carryover pair in
the Dimension® operating software. This function causes AMON to be scheduled
before ALC, thereby eliminating the potential for carryover.
This “carryover pair” function is active only when the instrument is in the “Optimize Time
To Result” rather than the “As Entered” mode. This function applies only to samples run
from the same cup. Therefore, we recommend using the “Optimize Time To Result”
option when customers use AMON and ALC on the same instrument.
In addition, carryover can be aggrevated by:
- Old or pitted R1 and sample prove tips.
- Misaligned probes to the drain, preventing adequate cleaning to eliminate contami-
nation.
- Dirty drains.
- R1 drain not emptying quickly.
a) Check capacity of the vacuum pump.
b) Decontaminate drain.
c) Replace drain.

A Methods 59
Result Monitor
Tab. 14 Limit Table:
Result Mon- Optical Fil- Minimum Maximum Above Mean Below Mean Error Mes- Statu
itor ters Reps Reps Factor Factor sage
A 340/383 20 100 1.15 0.75 abnl assay Active
B 340/383 20 100 1.25 0.50* abnl assay Active
*Change B side below mean factor from 0.75 to 0.50 per CSB D-0037 dated 12/5/2000.
Tab. 15 Method-Specific Troubleshooting

AMON A on first cuvette, no sample (blank) Check NADPH delivery by R1ARM
extrapolated, air blanketed Check Wells 1-3 for tablet hydration
blank rate at 340/383
Mean 800mA ± 40 τψπιχαλ
Limits are mean + 15% or -25%
B on second cuvette, sample Check NADPH delivery by R1ARM
extrapolated, air blanked Check Wells 1-3 for tablet hydration
Sample rate at 340/383
Result Monitor - “Abnormal Assay” Flag

• A and B side monitors the delivery of reagents with R1 and hydration of tableted wells
with R2 and R3.
• B side - sample specific.
- Patient samples that contain a total bilirubin concentration of approxiamately 15
mg/dL and higher.

60 A Methods
AMPH 2.11
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Amphetamine, qualified for urine only.

• Syva EMIT® II Plus method.
• Calibration curve fit at 0 µg/mL typically recovers above 0 µg/mL, for example:
Tab. 16 Acceptable AMPH Calibration
EXP UNCALC CALC

0 461 177
440 263
500 569 518
548 480
1000 CUTOFF 984 994
997 1006
2000 arithmetic 1950
arithmetic 2062
• Calibration guideline is ±10% only at the cutoff level for semi-quantitative mode. The
calibration guideline at the cutoff level is 975 - 1025 QUAL units for qualitative mode
(mean of N = 5).

A Methods 61
Troubleshooting 0
Error Messages
Absorbance
Indicates that the final optical density (FOD) limit for the method has been exceeded.
• Semi-quantitative mode only.
- Mix one part urine with one part purified water.
- Process the diluted sample and enter 2 in the dilution field.
- Evaluate the result and report based on the cutoff of each method.
- If diluted sample still has Absorbance errors, analyze the sample by an alternate
method.
• Qualitative mode only.
- Analyze sample by alternate method.
Low ‘A’ Error

A low rate might indicate that the enzyme reagent was not delivered to the cuvette.
• Root Cause:
- R2 probe misaligned or worn.
- R2 probe tubing (leaks).
High ‘A’ Error

Indicates that the final optical density (FOD) limit for the method has been exceeded. Most
probable cause is sample adulteration. Recommend recollection of the sample.
Abnormal Reaction
Indicates that foaming, air bubbles, or turbidity was detected in the cuvette.
• Root Cause:
- R2 probe misaligned.
- Reagent mixing inadequate due to R2 probe ultrasonics.
- Sample turbidity. Centrifuge sample and reassay sample after centrifugation.
Inaccuracy
Process five tests at the cutoff level. Mean should be ±10% cutoff level for semi-quantitative
and 975-1025 for qualitative.
• Incorrect calibrator levels used to calibrate the method.
• Incorrect bottle values entered.

62 A Methods
• Cross-reactivity: Antibodies may cross-react with related drugs and even unrelated
drugs. Refer to Emit® Drugs of abuse Methods cross-reactivity list and method insert
sheet.
• May detect Ecstasy (MDMA) in high concentrations.
• May detect Methyldopa (Aldomet) Metabolite
Imprecision
Process 5-test precision study using cutoff levels. Evaluate against SD claims.
• R1 probe.
• Clogged sample and/or reagent drains.
• Thermal chamber not seated properly.

A Methods 63
AMY 2.12
Method Chemistry 0

1 R1ARM (R1) 220 µL, (H2O) 130 µL Y
Method Specifics 0

• 6 well Flex®, all liquid reagents.
• Methodology = CNPG3.
• 452 nm used for substrate depletion error detection.
Troubleshooting 0

C0 = 0.000; C1 = 5.400 (standard volume)
C0 = 0.000; C1 = 7.560 (reduced volume)
• All urine specimens should be pretreated with Enzyme Diluent or equivalent before
analysis. Dilute 1 part of urine with 1 part of Enzyme diluent or equivalent. Enter dilution
factor of 2 in the enter data screen. The final albumin concentration in the urine should
be at least 3.0 g/dL to maximize amylase activity.
• Autodilution (AD) is not recommended for urines.
• Amylase activity is increased in the serum and urine of patients suffering from acute
pancreatitis.
• Urine QC and urine proficiency samples must be handled in the same manner as
patient samples (diluted 1:1 with Enzyme Diluent or equivalent).

64 A Methods
AST 2.13
Method Chemistry 0

1 R1ARM (R1) 100 µL, (H2O) 140 µL N
3 R2 ARM (R2) 65 µL, (H2O) 55 µL Y
Method Specifics 0

• 6 well Flex®.
• Methodology = P5P, oxalecetate>malate.
• Hydrations are done by 2500 µL syringe. Hydration QC volume is 12 µL for wells 1-3.
Hydration QC volume is 35 µL for wells 4-6.
Troubleshooting 0

C0 = 2.000; C1 = -3.537(standard volume)
C0 = -2.000; C1 = 7.040 (reduced volume)
• Sensitive to foaming due to low total cuvette volume and low dead volume in wells. As a
“low dip” (into the cuvette) method it is sensitive to R2 probe height alignment. A recent
tubing change (customer maintenance) may inadvertently change vertical sensor posi-
tion on the “top hat” (sensor mount). R2 arm mounting screw torque can create differ-
ent probe heights in different areas of the baseplate. Use diagnostics “bump routine” to
verify probe-to-cuvette height at 3-4 points on the baseplate.

A Methods 65
• The current AST method is sensitive to “FOAMING” after R2 reagent addition. A Photo-
metric read, r1 is taken 10 seconds after R2 addition. If R2 probe is misaligned, (probe
height too high), this will cause foaming. A foam check error, “Abnormal Reaction,” will
be generated if:
- Chk_v1_700>120 mA.
- Chk_v1_340>1999.9 mA.
• An Absorbance error is generated if:
- Chk_v1_700>120 mA.
- Chk_v1_340>1999.9 mA.
• Sensitive to 340/ 700 filter delamination.
DAR-120.
Tab. 17 Limit Table

A 340/700 60 250 1.2 0.75 abnl Active
assay
B 293/700 60 250 0.0 0.0 abnl Not
assay Active

66 A Methods

AST A on sample and reagents Check NADH delivery by R1ARM
Back extrapolated from r2, r3 Check wells 1-3 for tablet hydration
Mean 1100 mA ±70 typical
sample addition
Mean 1350 mA ±50 typical

A Methods 67
AUD 2.14
For BUN, CREA, PHOS, URCA 0
When urine is selected as sample fluid on the Enter Sample Data screen and BUN, CREA,
PHOS or URCA tests are requested, the sample is automatically diluted with system water
by the instrument to make a 1:10 dilution. Test results for these tests on urine samples are
then automatically calculated and printed out using 1:10 dilution.
NOTE There are different techniques used by the different Dimen-

sion® systems to perform the Automated Urine Dilutions
(1:10) for methods BUN, CREA, PHOS and URCA.
Tab. 19 AUD for BUN, CREA, PHOS and URCA
Techniques Diluting Final Dilu- Final Dilu- Final Dilu- Final Dilu-
Probes tion tion tion tion
AUD Method BUN CREA PHOS URCA
RxL non-HM Aliquot Monopump 1:10 1:10 1:10 1:10
Wheel
RxL HM HM Vessel Sample and 1:10 1:10 1:10 1:10
Sample
Flush
syringe
(2500uL)
Xpand/Xpan PUD* Sample and 1:10 1:10 1:10 1:10
d Plus (Cuvettes) R1 Metering
syringe
(500uL)
EXL HM Vessel Sample and 1:10 1:10 1:10 1:10
Sample
Flush
syringe
(2500uL)
*PUD- Photometric Urine Dilution using photometric cuvettes (two cuvettes per test)

68 A Methods
Method Chemistry
Non-HM Models Using Aliquot Wheel for AUD

Tab. 20 Non-HM models using Aliquot Wheel for AUD (1:10)

1 Monopump Urine-Sample 30uL, (H2O) 270 uL N
Total segment volume: 300 uL
HM Models Using HM Vessels for AUD

Tab. 21 HM Models using HM Vessels for AUD (1:10)

1 Sample Flush Urine-Sample 30 uL N
syringe (2500
uL)
2 Sample Flush (H2O) 270 uL Y
(2500 uL)
syringe
Total vessel volume: 300 uL
Dimension® Xpand®/ Xpand® Plus Using Photometric Cuvettes for AUD (also
known as PUD)
First Cuvette (sample dilution)
Tab. 22 Same for all PUD BUN, CREA, PHOS and URCA methods

1 R1ARM (500 uL metering) Add 240 uL (H2O) N
syringe
2 SAMPLE Urine-Sample 30 uL, (H2O) 30 uL Y
Total Cuvette Volume: 300 uL
Second Cuvette (Test Cuvette)

A Methods 69
Tab. 23 Method Specific (Ex. Urine-CREA)

1 R1ARM (R1) 74 uL, (R2) 18 uL, (H2O) Y
208 uL
2 SAMPLE 20 uL sample from first cuvette, Y
(H2O) 50 uL
Method Specifics
Non-HM Models Using Aliquot Wheel for AUD

• The dilution is made in the aliquot wheel using monopump.
• Uses QuikLYTE® IMT sample arm to pipette 30 uL Urine-sample + 270 uL water in the
aliquot wheel.
• Urine sample is diluted 1:10 in the aliquot wheel.
• Photometric SAMPLE arm is used to deliver diluted sample to the cuvettes.
• One aliquot position is used for each sample cup.
HM Models Using HM Vessels for AUD

• Urine dilution is made in the HM reaction vessel using 2500 uL sample flush syringe.
• In a HM vessel, 30 uL sample + 270 uL water is delivered by large, sample flush (2500
uL) syringe.
• A sample dilution of 1:10 is made for all AUD methods.
• If one, two, three or four Urine tests are ordered on a single cup of urine-sample, one
vessel will be used.
• If a 5-test precision is ordered on a cup for CREA, all five are sampled from one vessel.
• If 5-test precision is ordered on four separate sample cups, then four vessels will be
used.
NOTE The dead volume in a vessel is approximately 40 uL. If too

many tests are processed in a precision run for urine-tests,
the chance for short-sampling exists. There is no “level
sense” in the vessels.

70 A Methods
Dimension® Xpand®/ Xpand Plus Using Photometric Cuvettes for AUD (also known
as PUD)
• Photometric Urine Dilutions (PUD) features in Dimension® Xpand® and Xpand® Plus.
• Auto Urine Dilution (AUD) methods are BUN, CREA, PHOS and URCA. This is a 1:10
dilution with water, called out in Dimension® Xpand® software when sample is desig-
nated as a “urine”.
• Two cuvettes are assigned for each AUd method.
• If a 5-test precision is processed, system will use 10 cuvettes.
• The final sample dilution in the first cuvette is 1:10.
• Uses sample (100 uL)/ reagent R1 (500 uL) metering pumps.
• R1ARM delivers first cuvette with 240 uL of water.
• R1ARM delivers second cuvette with test reagents (14.4 seconds later).
• SAMPLE arm always adds 30 uL of Sample + 30 uL of water to the first cuvette to make
1:10 dilution and is transferred to second cuvette by SAMPLE arm, for all AUD meth-
ods.
• The volume of the diluted sample transferred to second cuvette is based on test-sam-
ple volume.
• If reduced sample volume is used, reduced sample volume is transferred to the second
cuvette with additional chase (H2O).
• Sample probe is washed between steps.
Troubleshooting
Precision
1. Run a 5 test precision on the suspected method as CUPS/SERUM.
2. Run a 5 test precision on the same sample as CUPS/URINE.
3. Compare and evaluate results.
4. Compare to a manual dilution if necessary.
For EZCR 0
For EZCR urine samples are automatically diluted 1:20 with system water on all systems
before running the test. Test results for EZCR on urine samples are then automatically cal-
culated and printed using the 1:20 dilution. The EZCR method uses the Photometric Urine
Dilutions (PUD) dilution technique to perform urine dilutions on ALL Dimension® systems.

A Methods 71
Tab. 24 AUD for EZCR
Techniques Diluting Final Dilution Final Dilution

Probes
AUD Method EZCR
RxL non-HM PUD* Sample and R1 1:20
(Cuvettes) Metering
syringe (500uL)
RxL HM PUD* Sample and R1 1:20
(Cuvettes) Metering
syringe (500uL)
Xpand/Xpand PUD* Sample and R1 1:20
Plus (Cuvettes) Metering
syringe (500uL)
EXL PUD* Sample and R1 1:20
(Cuvettes) Metering
syringe (500uL)
*PUD- Photometric Urine Dilution using photometric cuvettes (two cuvettes per test).
Method Chemistry
First Cuvette (sample dilution) - Method Specific for EZCR Urines
Tab. 25 First Cuvette (sample dilution) - Method Specific for EZCR Urines
Event # Event Delivery Volumes/Filters Mix

1 R1ARM (500 uL Metering) Add 240 uL (H2O) N
syringe
2 SAMPLE Urine-Sample 15 uL, (H2O) 45 uL Y
Second Cuvette (test cuvette) - Method Specific for EZCR

72 A Methods
Tab. 26 Second Cuvette (test cuvette) - Method Specific for EZCR

1 R1ARM (R1) 110 uL, (H2O) 170 uL Y
2 SAMPLE 6 uL, (H2O) 15 uL Y
4 R2ARM (R2) 118 uL, (H2O) 20 uL Y
Method Specifics
• This is a 1:20 dilution with water when the sample is designated as “urine”.
• Two cuvettes are assigned for each test.
• The final sample dilution in the first-cuvette is 1:20.
• Uses sample/reagent metering pumps.
• R1ARM fills first cuvette with 240 uL of water.
• R1ARM fills second cuvette with test reagents.
• SAMPLE arm always adds 15 uL of Urine sample + 45 uL of water to the first cuvette to
make 1:20 dilution and is transferred to second cuvette by SAMPLE arm.
• The volume of the diluted-sample transferred to second cuvette is 6 uL.
• Reagent R1 and R2 probes are washed between reagent delivery with NaOH using the
pre-reagent wash command. See EZCR method page for details.
NOTE PUD was used to standardize the urine enzymatic creatinine

patient, quality control and proficiency results across all plat-
forms. The 1:20 dilution was used to extend the urine mea-
surement range. Correct instrument software versions are
required to run the EZCR method.

B Methods 73
3-
BARB
3B Methods
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2 ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Barbiturate, qualified for urine only.

• Calibration guideline is ±10% BV only at the cutoff level for semi-quantitative mode. The
calibration guideline at the cutoff level is 975-1025 QUAL units for qualitative mode
(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance
• Semi-quantitative mode only:
method.

74 B Methods
• Qualitative mode only:

Low ‘A’ Error

• Root cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
Innacuracy
• Incorrect calibrator levels used to calibrate method.
drugs. Refer to Syva EMIT® Drugs of Abuse Methods cross-reactivity list and method
insert sheet.
Imprecision
• R1 probe.
• Clogged sample and/ or reagent drains.

B Methods 75
Carryover Pairs
• TU/BARB

76 B Methods
BENZ 3.1
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2 ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Benzodiazepine, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance
• Semi-quantitative mode only:
method.

B Methods 77
• Qualitative mode only:

Low ‘A’ Error

• Root cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
Inaccuracy
• Incorrect calibrator levels used to calibrate method.
insert sheet.
• Does not detect glucuronide conjugates of benzodiazepines.
Imprecision
• R1 probe.

78 B Methods
BNP 3.2
Method Chemistry 0
Event # Time Event Delivery Volumes/ Filters Mix

1 -598.2 sec Sample (Sample) 15 µL / (H20) 15 µL N
2 -578.6 sec R2ARM R2 (Chemibead-Ab) 20 µL N
R2ARM R1 (Biotinylated-AB) 20 µL
3 -140.0 sec R2ARM R3 (Sensibead) 15 µL / (H20) 15 µL N
4 -46.5 sec R2ARM R4 (Assay Buffer) 100 µL / (H20) 50 µL N
5 0 sec LOCI ARM LOCI Read Vessel (4 reads) N
Total Reaction Vessel Volume: 250 µL
Method Specifics 0
• LOCI method, a homogeneous, sandwich chemiluminescent assay.

• BNP method is only available on the Dimension® EXL™ system with LOCI® Module.
• The LOCI BNP method has been evaluated with plasma using EDTA as the anticoagu-
lant. Serum, sodium citrate, lithium heparin, and sodium fluoride sample tubes have
also been tested and are not recommended.
• BNP samples are stable for 8 hours at ambient temperature, 12 hours refrigerated. If
separated EDTA plasma samples are not tested within 12 hours, store samples in plas-
tic tubes and freeze at or below -20°C in non-frost free freezers. Samples may undergo
up to 4 freeze/thaw cycles without degradation. Samples are stable up to 9 months
when stored frozen at or below -20°C.
• Flex type = 8 well, all liquid reagents. All BNP reagents are liquid; however, chemibead
and sensibead reagent wells are mixed by the instrument when the well is first punc-
tured. Mixing is performed by the R2 or R3 probe (RMS). Mixing is accomplished by
aspirating a fixed volume of reagent from the well and then dispensing it back into the
same well (referred to internally as “sip and spit mixing”). This process is performed
automatically when a new chemibead or sensibead well is punctured. This process can
be pre-programmed using the inventory/hydration screen.
• Coefficients: C0 = 1.0, C1 = 3775.0, C2 = -1.7, C3 = 1847.0, C4 = 0.01
• The BNP method uses the 5-level LOCI BNP calibrator, RC624. The approximate con-
centrations are 0, 100, 1000, 2500, 5400 pg/mL. During calibration each calibrator level
is analyzed for three replicates. The BNP method is a logit method and the calculated
slope (m) should be between 0.95 and 1.05. The intercept (b) should be 0.0 or clinically
insignificant. The correlation coefficient (r) should be between 0.990 - 1.000.

B Methods 79
• The assay range for the EXL BNP method is 6 - 5000 pg/mL. The BNP method reports
to 1 decimal place. Over-range samples can be manually diluted with EXL/Vista MULTI
2 SDIL (Cat. No. KD694). The recommended dilution factor is 5.
Troubleshooting 0
• XLINK instructions can be found in the Dimension EXL XLINK Functional Description
(DCIN-A03.850.15 / Introducing Xlink). Chemdata file will contain summarized BNP QC
data. LOCIDATA file contains LOCI reads and module level checks. Standard Dimen-
sion filterdata holds no BNP or LOCI method information. LOCIDATA can be obtained
via the snapshot directory. Software versions 9.0SP3 and higher will have the “get
LOCIDATA” command which will pull most recent LOCIDATA (similar to “get filterdata”
command).
• All deliveries of reagent to the reaction vessel are performed with R2 arm. Sample
delivery to reaction vessel is performed by the sampler. Basic accuracy and precision
troubleshooting should start with checking R2 alignments/fluidics, followed by sampler
alignments/fluidics.
• Abnormal reaction errors (abnl reaction) are generated when a sample produces a
Kcount less than 1/2 the mean recovery of the level A calibrator (zero calibrator). Fre-
quent occurrence of this error indicates either the wrong calibrator level run, or a
reagent delivery issue with the chemibead or biotinylated antibody. If the error is spe-
cific to a single sample, the samples should be diluted 1:2 with a sample that has a
known concentration. If the sample does not recover appropriately, an interferrent
should be suspected.
• Measurement Errors are generated when the low signal value (1/2 the mean recovery
of level A calibrator) used to trigger the abnormal reaction error is missing. This can
occur if the calibration is processed but not accepted.
• The LOCI BNP calibrator is a frozen calibrator and is sensitive to storage and handling
conditions. See calibrator IFU for storage and handling conditions. Calibrators must be
stored in a non-frost free freezer.
• Currently available commercial quality control materials are sensitive to storage and
handling conditions. Both BioRad and MAS cardiac control products indicate that the
product is stable within their claims when product is stored in a non-frost free freezer.
• BNP immunoassay reaction is dependent on the absolute temperature setting of the
HM ring. On the Dimension RxL and Xpand systems, the incubation temperature of the
reaction vessel on the HM wheel is 42°C. On the Dimension® EXL™ with LOCI® Mod-
ule, the temperature of the HM incubation wheel has been adjusted to maintain the
reaction vessel at 37°C for all HM and LOCI methods. The HM temperature specifica-
tion on the Dimension® EXL™ with LOCI® Module Daily Maintenance log is 37.3 -
39.6°C - the temperature range is of the HM ring itself, not the air bath or liquid in a reac-
tion vessel. If an instrument is set to a higher HM ring temperature, assay sig-
nal-to-noise will decrease. Assay performance drops off sharply at temperatures above
40°C. Sudden decreases in BNP kcount signal accompanied by a drop in sig-
nal-to-noise should trigger investigation into possible temperature issues with the HM
module, or incorrect temperature calibrations made by the customer.

80 B Methods
• The LOCI Read routine is composed of 3 distinct reads which occur in this order:
1. Pre-read
2. Assay read
3. Gain read
The pre-read and gain reads produce diagnostic information to identify a malfunction-
ing LOCI detector, shutter, or light-emitting diode (LED). Both occur on an empty read
chamber with no vessel present. For BNP, the assay read is composed of four assay
read cycles. For each assay read cycle, the reaction vessel is illuminated for 200 msec,
and after a 100 msec gate delay, the chemiluminescent signal is collected 1000 msec.
Total signal, reported in kilo-coounts (kcounts - found in the LOCIDATA file under the
Primary Column with LEGEND: LOCI BNP. This is the sum of the 4 assay read cycles in
counts / 1000). These 4 assay read cycles, referred to as ASY CPM rd 1-4 in the LOCI-
DATA file, produce consistent pattern counts at reportable BNP concentrations. The
pattern of the 4 reads may be valuable as misdelivery of reagent may show an abnor-
mal pattern.
Results Monitor
The BNP method uses the readVF as a result monitor, this is found in the LOCIDATA file in
the column ASY TOT VF. ASY TOT VF is the sum of the four ASY VF Rd. The ReadVf mea-
sures the amount of light from the LED that gets detected by the illumination photocell. This
read occurs when the sample reaction vesel is in the LOCI reader. An unusually high
ReadVf occurs when there is no or a drastically reduced amount of sensibead reagent in
the assay. The methpar is set up to create an “Abnormal Assay” error in this case. Likewise,
a low ReadVf can occur if the sensibeads have settled and are not sufficiently resuspended
during the sip and spit mix routine.
The ReadVf for an assay is specific for a given instrument and may also vary with the
reagent lot or change after major work in the instrument. Therefore, results monitoring is
required to reliably detect this type of error. The first 30 results with a new flex lot or cali-
bration are averaged and the 31st result is the first to be checked with the results monitor.
It passes if it is within ±20% of this average and is then included in the average. After a total
of 250 tests, the running average over the last 250 passing results is used.
Abnormal Assay Troubleshooting should include checking R2 and R3 alignments to flex,
followed by R2 and R3 fluidics.
Contamination Read
The contamination read occurs after the illumination LEDs have been fired during the
pre-read. The contamination read should normally show the noise floor of the reader. In
software version 9.0SP3 and higher, the read can be found in the LOCIDATA file under the
column Contamination. In prior software versions the Contamination column will always
read “0” - the contamination read can be calculated by multiplying the PRE Tot CPM col-

B Methods 81
umn by 3. The contamination value must be within 4 times the mean and below 45 counts
per second (0.045 kcps). If a contamination read exceeds acceptable limits it will produce
Error 849 - Failed Reader Contamination Check and the test will not process.
Should the system flag a contamination error, the arm suction cup should be replaced
along with the LOCI insert and retainer rubber seal. LOCI arm alignments should be per-
formed following replacement. Additionally the HM incubation wheel should be examined
to ensure there is not reagent spillage that could contaminate the vessel. Close examina-
tion should be done in the R2 delivery area. Should there be any stray fluids, cleanup
should be performed, along with realignment of the R2 arm.
Illumination Read
The illumination read is a measurement taken with the illumination photodiode at the begin-
ning of the pre-read. Acceptable range of the illumination read is between 150,000 -
500,000 counts. In software version 9.0SP3 and higher the illumination read should appear
in the column illumination in the LOCIDATA file. In prior software versions the Illumination
column will always read “0” - the illumination read can be calculated by multiplying the PRE
Tot VF column by 2. The illumination value must be within 2.5% and 7 standard deviations
from the mean. If the value is greater than 7 standard deviations it must be within 1% of
mean. If the illumination read exceeds acceptable limits it will produce Error 850 - Failed
Reader Illumination Check. Illumination failures are primarily noise related and the electri-
cal components should be inspected to ensure cable routing is correct. If problem persists,
change LOCI board followed by the reader. If noise in the illumination value is found and
corrected the LOCI statistics file should be reset.
Gain Read
The gain read is taken after the method read. For every LOCI method read, data related to
Gain Tracking and Shutter Checking is acquired. This is performed in the gain read. During
the gain read the CPM response to the gain LED is referenced to the gain photodiode mea-
suring the same signal. Three values output into the LOCIDATA file. These are GAIN Tot
CPM, GAIN Tot VF (the signal as measured by the gain photodiode) and the ratio of the
two or Relative Gain. Acceptable Relative Gain ratios are between 1.0 - 8.5. Values must
also be within 4% of the running mean and 5 standard deviations.
The Relative Gain ratio can be used as a CPM / PMT drift monitor. Gain ratio should not
drift > 1.0% of the course of a month. If a customer complains of a QC trend over time or
not meeting the claimed calibration interval, the Relative Gain ratio should be checked.
Take the mean of the Relative Gain ratio reads from Day 1 and compare with the mean of
Relative Gain ratios from Day 30.
Gain read errors typically stem from two issues. Most issues will occur as the result of a
semi/nonfunctional shutter. Next, as normal CPM / PMT signal response degrades over
time the CPM may have truly fallen out of its usable life, and have a Relative Gain ratio of
below 1.0. This, however, should not happen for years of use. Persistent gain read errors
or significant CPM / PMT drift necessitates replacement of the reader.

82 B Methods
Non-Delivery of Reagents or Sample

Completely missing biotinylated antibody or chemibead reagent eliminates specific LOCI
signal and is expected to result in very low signal counts; slightly lower than calibrator level
1. If signal is low enough, it could likely trigger the “abnl reaction” error. At this time, there
is no available data that can specifically flag these failures. Partially missing biotinylated
antibody reagent or chemibead reagent (a short reagent delivery) is not easily identifiable.
The amount of signal loss depends on the amount of reagent that is missing.
Non-delivery of sensibead reagent is flagged by Abnormal Assay message - See Results
Monitor .
Completely missing assay buffer has a subtle effect on LOCI signal. This could easily go
unnoticed. At the low end of the calibration curve, there would be slightly higher LOCI sig-
nal than a normal curve, but above Cal 2 there would be about 5% to 10% lower signal.
The ReadVF signal would be almost 10% higher.
Completely missing sample eliminates specific signal due to analyte and is expected to
result in signal counts slightly higher than calibrator level 1. This error would not be flagged.
The elevated signal is due to the increased “cross-talk” between chemibeads and sensi-
beads that results from the smaller reaction volume and absence of matrix proteins nor-
mally contributed by the sample (which are weak singlet oxygen quenchers). Partially
missing sample is not easily identifiable. The amount of signal loss depends on the amount
of sample that is missing.

B Methods 83
BUN 3.3
Method Chemistry 0

1 R1ARM (R1) 90 µL, (H2O) 230 µL N
2 SAMPLE 3 µL, (H2O) 47 µL Y
Method Specifics 0

• Sample initiated; sensitive to sample fluidics, sample ultrasonics. No sample mix will
give lower results by -20%.
• Hydration of wells 1-3 using wells 4-6 (intra-Flex® transfer).
• Dimension® RxL/RxL Max non-HM Module: (see AUD for additional details)
Automated Urine Dilutions (AUD). A 1:10 dilution is performed in the aliquot wheel
segment. The dilution is performed using Monopump for sample aspiration and dilu-
tion. The Photometric Sampler transfers the diluted sample to the cuvette.
• Dimension® RxL/RxL Max/EXL/EXL with HM Module: (see AUD for additional
details)
Automated Urine Dilutions (AUD). A 1:10 dilution is performed in the HM Vessel. The
dilution is performed using 100 µL Sample Syringe for sample aspiration and 2500 µL
Sample Flush Syringe for dilution. The Photometric Sampler transfers the diluted sam-
ple to the cuvette.
• Dimension® Xpand® and Xpand® Plus clinical chemistry system: (see AUD for
additional details)
Automated Urine Dilutions (AUD). A 1:10 dilution is performed in the First Photomet-
ric Cuvette, PUD (Photometric Urine Dilutions). The dilutions are performed using 100
µL Sample Syringe for sample aspiration and 500 µL R1 Metering Syringe for the dilu-
tion. The Photometric sample transfers the diluted sample from the First cuvette to the
second cuvette.

84 B Methods
Troubleshooting 0
• High outliers can be caused by a dirty or plugged sample drain. If cleaning does not cor-
rect it, replace the drain. Also check for clogs in vacuum drain tubing and waste mani-
fold.
• The R2 ARM aspirates a large volume (1000 µL) of viscous reagent from wells 4-6 and
adds it to wells 1-3, which contain a tablet. If not enough of the liquid is added to the tab-
let, it will show up as a calibration shift downward. Method is an intra-Flex® transfer
method so susceptible to coring. Low or negative results can be caused by lack of
reagent. Check to see if test was at end of well. Replace 2500 µL R2 syringe tip, and
check R2 probe to Flex® height adjustment.
• Reagent preparation errors- failed quality assurance can be caused by loose R2 probe
tip. Tighten to correct.
• Result Monitor A (Abnormal Assay A) Low.
- There is a normal steady decrease in the absorbance of NADH reagent. All users
may find the Result Monitor A values decrease over the 5-day life of the well set and
generate “abnl assay” errors. The result Monitor A below mean factor may be
adjusted from 0.92 to 0.80 (Support Bulletin D-0214) for all Dimension® systems.
- A drastic Result Monitor A dip may be caused by reagent contamination by the R1
probe. Troubleshoot by changing the R1 probe, check R1 alignment, clean or replace
the R1 drain.
- Typical limits for Result Monitor A are 700-900 mAU.
- Software default limits for Result Monitor A are 0.92 for Below Mean Factor and 1.08
for Above Mean Factor.
Calculated Results Associated with BUN

With the addition of a new enzymatic creatinine method (EZCR) on the Dimension® sys-
tems, a new BUN/ Creatinine ratio calculation has been developed.
With newer Dimension® software versions that include the EZCR method, there are two
separate equations for the BUN/ Creatinine; one using CREA and one when using EZCR
creatinine methods. See EZCR method sheet for SW versions.
Calculated results BUN/ Creatinine ratio using the following equations:
BUN/ Creatinine Ratio: (BN/CR)

BN=BUN, CR=CREA
• BN/CR= (BUN) (k) / CREA
• K=1 if both results are reported in mg/dL
• K=1000 if BUN is reported in mmol/L and CREA in µmol/L
BUN/ Creatinine Ratio: (BN/EC)

B Methods 85
BN=BUN, EC=EZCR
• BN/EC= (BUN) (k) / EZCR
• K=1 if both results are reported in mg/dL
• K=1000 if BUN is reported in mmol/L and EZCR in µmol/L
NOTE A new equation was necessary in order to enter a BN/EC ref-

erence interval.
Result Monitor
Tab. 27 Limit Table

A 340/383 80 250 1.08 0.92 abnl Active
assay

BUN A on sample and reagents Check NADH delivery by R1ARM
Back extrapolated from r2, r3 Check Wells 1-3 for tablet hydration
At analytical 340/383 reagent
Mean 700-900 mA ± 20 typical


86 C Methods
4-
C3
4C Methods
Method Chemistry 0

1 R1ARM (R1) 105 µL, (H2O) 200 µL Y
2 SAMPLE 2 µL, (H2O) 63µL Y
5 R2ARM (R2) 50 µL, (H2O) 60 µL Y
Method Specifics 0

• Turbidimetric method.
• Calibration curve is logit.
• Calibration volume is 9 µL, QC and patient sample volume is 2 µL. Cannot run calibra-
tors as unknowns.
• Calibration Scheme: Five levels in duplicate.
• Autodilution not available; make manual dilutions with saline.
Troubleshooting 0
“Abnormal Reaction” Errors

Checks for foaming and turbidity, check 700 (r1 [700] - r0 [700]) > 5 mAU or non-specific
turbidity (nst) > 8.
• Centrifuge cloudy or turbid samples, may need to dilute the sample.
• Frozen samples may have gone through the freeze/thaw cycles, which aggregate when
mixed with buffer containing PEG. This would cause atypically low values due to falsely
elevated sample blank. Collect fresh samples.

C Methods 87
• Non-specific aggregation due to sample quality issues such as fibrin strands, clots, cel-
lular debris, etc.
• Multiple myeloma samples may aggregate spontaneously when mixed with buffer or
diluent. Try alternate methodology.
If errors are seen with clear samples:
• Align sample and reagent probes; misalignment could cause foaming.
• Worn sample and reagent probes may cause mixing problems.
• Check for dirty windows. High absorbance readings will trip the abnormal reaction flag.
• Check cuvette manufacturing for dimpling and rolling.
If the “abnormal reaction” error message occurs with every sample (including calibrator) or
if related methods (C4, IGA, IGG, IGM, & TRNF) are also affected, check the following:
• Tag readings for empty cuvettes. Readings at -72 seconds should be around 200 mA
for all wavelengths.
- High reads and high SD’s for all cuvettes across all wavelengths may indicate aging
source lamp or loose cable connections.
- Sporadically high reads across all wavelengths may indicate dirty windows.
- High reads for all cuvettes at a particular wavelength may indicate a bad filter.
• Snapshot to check the readings of the photodiode. In cases of abnormal reaction, the
snapshot may read in the 90’s (atypically high - typical readings are 50 to 70).
Accuracy of Patients and QC

• Worn sample or reagent probes.
• Misaligned sample or reagent probes.
• Change sample metering syringe (100 µL).
• Change R2 (500 µL) syringe.
• Bent or pinched sample or reagent tubing.
Precision Issues
• Check cuvette manufacturing.
• Clean windows.
• Replace source lamp.
• Worn or misaligned sample or reagent probes.
• Pinched sample or reagent tubing
• Replace appropriate syringe.

88 C Methods
C4 4.1
Method Chemistry 0

1 R1ARM (R1) 105 µL, (H2O) 200 µL Y
5 R2ARM (R2) 50 µL, (H2O) 60 µL Y
Method Specifics 0

• Calibration volume is 27 µL, QC and patient sample volume is 3µL. Cannot run calibra-
tors as unknowns.
• Calibration Scheme: Five levels in duplicate.
• Autodilution not available; make manual dilutions with saline.
Troubleshooting 0

Checks for foaming and turbidity, check 700 (r1 [700] - r0 [700]) > 5 mAU or non-specific
turbidity (nst) > 8.
• Centrifuge cloudy or turbid samples, may need to dilute the sample.
• Frozen samples may have gone through the freeze/ thaw cycles, which aggregate
when mixed with buffer containing PEG. This would cause atypically low values due to
falsely elevated sample blank. Collect fresh samples.

C Methods 89
lular debris, etc.
• Multiple myeloma samples may aggregate spontaneously when mixed with buffer or
diluent. Try alternate methodology.
• Align sample and reagent probes; misalignment could cause foaming.
if related methods (C3, IGA, IGG, IGM, & TRNF) are also affected, check the following:
• Tag readings for empty cuvettes. Readings at -72 seconds should be around 200 mA
for all wavelengths.
snapshot may read in the 90’s (atypically high - typical readings are 50 to 70).

Precision Issues
• Clean windows.
• Worn or misaligned sample or reagent probes.
• Pinched sample or reagent tubing

90 C Methods
CA 4.2
Method Chemistry 0

Method Specifics 0

• Well to well inconsistencies can cause inaccuracies.
• Contamination from powdered gloves due to talc powder-Mg silicate will falsely
increase results.
• Normal to see slightly discolored reagent (purple) where probe enters Flex®. This is
caused by reagent carryover - it is a double dip method. This discoloration does not
cause any problems.
• CARP- Calcium Rich Precipitant: a phoenomenon where CA will settle downward
within a sample and cause an elevated CA result. To reduce this phoenomenon, it is
necessary to run CA’s within 20 minutes of pouring the sample into the container or run-
ning it at least 5th in a panel. Running the 5th test in a panel will cause the sample to be
re-mixed by the action of the probe entering the sample container numerous times.
• Urine: No dilution is required, but method is qualified to use autodilute volume of 2 µL. It
is recommended that the 24 hour specimen collection should be preserved with 10-20
mL 6M HCL to prevent calcium from precipitating out.
• Uses “super-flush” wash on sample probe, in the container (cup) mode only.
• Containers (cup) high versus tube - calibration with container may make patients in
tubes appear low due to sample carryout. Run splits on full container versus tube. XL
performs a level sense on all samples.
• Inernal wash efficiency of the sample probe and sample tubing - high sample size
method, may not wash out and may elevate CA run behind it.
• External bias: construction dust, gloves (talc), water, film. Store sample containers cov-
ered.

C Methods 91
• Susceptible to water contamination; some brands of bleach contain calcium hypchlo-

rite, and if used to clean out water bottles, etc., can cause high CA results.
• Gadolinium-containing contrast agents, like OMNISCAN®, interfere with the CA
method. CA results determined in the 24-hour period following administration of the
contrast agent may be falsely low (Support Bulletin D0226).
• CA and MG shifts and high outliers may be caused by a bad Millipore check valve on
the AFS10 and 18D systems only.
• Use reagent QC for H2O contamination - see note DAR-64.
• Carryover Pairs: LIPL, CA
Troubleshooting 0
• Sample probe misting - bent sample probe can cause imprecision.

• Water temperature can cause accuracy shifts. Check for Millipore/ water temperature
changes throughout the day; should be constant.
Result Monitor
Tab. 29 Limit Table

A 405/452 60 250 +5 SD -5 SD abnl Active
assay
B 577/540 60 250 1.07 0.97 abnl Active
assay

92 C Methods

CA A on reagent only Check OCPC delivery by R1ARM
Endpoint at r2 Check reagents in Wells 7,8 are liq-
At reagent max 405/452 uid

Limits are mean ± 5 SDs
B reagent blank Background calcium correction due
Endpoint at r2 to water, contamination

C Methods 93
CCRP 4.3
Method Chemistry 0
HM Vessel Processing

1 R2ARM (R2: CrO2) 30 µL, (H2O) 80 µL N
2 SAMPLE (Sample) 12 µL, (H2O) 48 µL N
3 R2ARM (R1: conjugate) 50 µL, (H2O) 30 µL N
MAGNET Chrome Separation
Total Vessel Volume: 250 µL
First Cuvette (Sample Processing)

1 R1ARM (R4: ONPG) 175 µL, (H2O) 125 µL Y
3 SAMPLE (Sample from vessel) 30 µL, (H2O) 60µL Y
6 PHTO READ 405/510 nm
Method Specifics 0
• Simultaneous sandwich format, ONPG detection.

• CCRP reagents.
Well 1 conjugate (ß-galactosidase) reagent

Well 2 empty
Well 3 1 tablet chrome hydrated with 1800 µL of H2O
Well 4, 5, 6 ONPG reagent

94 C Methods
Well 7 empty
Well 8 empty
• CRO2 delivery monitored by result monitor A. Limits 0.65 to 1.25 around mean.
• ONPG Reagent delivery monitored by result monitor B. Limits 0.75 to 1.10 around
mean.
Troubleshooting 0
ONPG Delivery
• Result monitor B limits will be exceeded, resulting in “Abnormal Assay” message. Pos-
sible causes of low readings include:
- R1 probe misaligned to cuvette.
- Inadequate reagent in Flex well.
- Color change in reagent due to excessive heat or well contamination.
- R1 probe tip worn.
- R1 tubing, syringe or solenoid problems.
• Possible causes of high readings include:
- R1 probe misaligned to cuvette.
- Loose R1 probe or fittings.
- Low cuvette volume-air in R1 tubing.
- Overactive R1 transducer.
- Cuvette manufacturing issues.
Chrome Delivery
• Result monitor A limits will be exceeded, resulting in “Abnormal Assay” message. Pos-
sible causes of low readings include:
- Missing chrome tablet in well.
- Underhydration of chrome well.
- Undissolved tablets.
- R2 remix of chrome well.
- R2 chrome transfer to reaction vessel.
- Chrome loss at wash station (magnet and wash probe alignments).
- Chrome clumping due to sample clotting.

C Methods 95
• Possible causes of high readings include:

- Incorrect number of tablets per well (there should be 1).
- Underhydration of chrome well.
- Improper resuspension of chrome in reaction vessel.
- Foaming in cuvette.
Imprecision
• R1 not centered to cuvette.
• R1 probe alignment too high (foaming).
• R2 not centered to reaction vessel.
• Poor chrome re-mix in Flex.
- Weak R2 ultrasonics.
• Low reagent delivery by R1 probe.
• Inadequate washing.
- Clogged wash probes.
- Worn wash pump cassettes.
- Wash probe tubing issues.
- Wash probe mixer issues.
• High shipping/storage temperature (low temperature has no effect).
• Reagent or sample carryover.
- Worn probes.
- Drains.
Inaccuracy
• Low or high sample delivery.
- Sample fluidics.
- Sample probe alignments.
• Inadequate washing.
- Clogged wash probes.
- Worn wash pump cassettes.
- Wash probe tubing issues.
- Wash probe mixer issues.
• Chrome clumping.
- Fibrin in sample.
• Low reagent delivery by R1 probe.
• High shipping/ storage temperature (low temperature has no effect).

96 C Methods
• Reagent or sample carryover.

- Worn probes.
- Drains.
• HAMA.
Results Monitor
Tab. 31 Limits
Rslt Optical Mini- Maxi- Above Mean Below Mean Error Mes- Status
Mntr Filters mum mum Factor Factor sage
Reps Reps
A 700 15 250 1.25 0.65 abnl assay active
B 405/510 15 250 1.10 0.75 abnl assay active

CCRP Reagent QC-1: monochro- cr02 indicator
matic
Reagent QC-2: bi-chromatic reagent blank

C Methods 97
CHK 4.4
Method Chemistry 0
(SABS) Non-HM Instruments

1 R1ARM (R1) 0 µL, (H2O) 345 µL Y
3 SAMPLE (CO2SO4) 5 µL, (H2O) 50 µL Y
4 PHOT READ 510/405nm
(SCHK) HM Instruments - only (automated SCHK) cuvettes

1 R2ARM 50 µL of Ponceau S, (H2O) 50 µL to vessel Y
2 R1ARM R1 0 µL, (H2O) 345 µL Y
4 SAMPLE Ponceau S 10µL, (H2O) 45 µL Y
First Cuvette (R1BS)

1 R1ARM (R1) 60 µL, (H2O) 420 µL Y

98 C Methods
Second Cuvette (R2BS/ PQC)

3 R2ARM (R2) 60 µL, (H2O) 420 µL Y
About CHK Flex Reagent Cartridge (DF179) 0
Dimension CHK Flex® reagent cartridge (DF179) is a non-hazard, liquid-stable reagent

composed of red organic dye (Ponceau S), buffer, and preservative. The product is used
to check the proper functioning of the sample and reagent fluid metering systems as well
as the photometric measuring system on all the Dimension® integrated clinical chemistry
system. It will continue to maintain system performance and aid in troubleshooting system
issues. The System Check will work differently depending on a non-HM instrument versus
an HM instrument.
The user can configure Dimension® in ABS or CHK modes.
For HM systems the CHK will have the function to eliminate manual sample transfer and
allow scheduling of system check automatically. This is done by use of a new sampler
method (SCHK). SCHK usees an R2 delivery from the Flex® into the vessel, and then the
sampler delivers fluid from the vessel into a cuvette.
• Daily maintenance can be scheduled 24hrs in advance.
• Instrument will automatically repeat a failed scheduled Daily Maintenance 1 time.
All service method mnemonics (R1BS, R2BS, RIMS, DABS, HABS, NAOH, W1BS, W2BS,
CLRX) are unchanged from old systems. SCHK has been added for “CHK enabled” HM
systems. Non-HM instruments will continue to use SABS. The user will still have to place
the CHK solution into a sample cup to perform a System Check.
Flex Configuration
Fig. 1: Flex Configuration

C Methods 99
Flex Information:
• 2 System Checks per Flex®:
- HM: 3 wells for reagent
- Non-HM: 2 reagent + 1 sample well
• Store refrigerated
• 8 Flex® cartridges per carton
• System Checks always use fresh wells
Method Specifics 0
• Endpoint, bichromatic, 510/ 600 nm.

• A system check schedules 5 SCHK tests for HM instruments and 5 SABS tests for
non-HM instruments (first 5 cuvettes). It then schedules the CHK method, which is
essentially a “two cuvette” method which alternates between R1BS and the R2BS
assay. Two blank reads on the R2BS cuvette prior to any fluid deliveries are used for
the PQC test for all ten wavelengths. As with the original system check, only the high-
est PQC result of the 5 cuvettes read will be printed on the report slip. This results in 5
SCHK for HM instruments and 5 SABS cuvettes for non-HM instruments in a row, fol-
lowed by 10 “reagent” test cuvettes, alternating R1BS and R2BS respectively. This only
holds true if there are no dirty windows or bad cuvettes (all scheduled windows are used
- non are skipped).
• Put up: 30 tests per Flex® 5/5/5/5/5/5 (Ponceau S)
Tab. 32 CHK Flex® reagent cartridge usage
Instrument Type New reagent cartridge test Number of system checks

count inventory per reagent cartridge
Dimension® RxL (non HM) 15 3
Xpand® (non HM)
Dimension® RxL HM, RxL 10 2
HM/RMS, Xpand® HM/EXL
w/LM, EXL 200
• RxL with HM and RMS using 15 out of 30 tests in the reagent cartridge or 1 out of 2 sys-
tem checks:
- 10 tests will display (2 system checks).
- Uses 5 systems: R1, R2, Sampler, HM Wash, RMS = 5 system tests.
R1 = 5 tests
R2 = 5 tests

100 C Methods
- SCHK, HM and RMS use the same well = 5 tests.

- Sampler uses CHK in cup for non-HM instruments.
CHK Flex® wells 1, 2, 3, 4 & 5 contain 640 µL Ponceau S. Wells 3 & 6 contain 1270 µL
Ponceau S. The additional volume is used by R3 of RMS module (RMS) if the instrument
is equipped with RMS optional reagent storage unit.
Troubleshooting 0
CHK Troubleshooting
In addition to the following troubleshooting tips on “System Check,” refer to the specific
Dimension® Operators Guides for basic information.
“System Check” tests are chemistry free performance checks of critical fluid movement and
photometric electromechanical instrument components. The performance checks are
made using a dye solution of Ponceau S to eliminate any reactive variables.
These tests are identified and defined as follows:
• Photometer (PQC): Photometer drift QC stability test.
- Specs: Wavelength drift limited to ±1.5 mAU for all wavelengths except for the 293
nm wavelength whose limit is ±2.5 mAU.
- Specs: Assay value listed on the end flap of the CHK cartons ±15 mAU.
• Reagent #2 (R2BS): Checks accuracy and precision of the reagent pumps
- Specs: Assay value listed on the end flap of the CHK cartons ±15 mAU.
• Sampler (SABS) non-HM instruments: Checks accuracy and precision of the sample
pumps.
- Specs: Mean = 10% of the assay value listed on the end flap of the CHK carton ±2
mAU.
• Sampler (SCHK) HM instruments: Checks accuracy and precision fo the sample
pumps.
- Specs: Mean = 10% of the assay value listed on the end flap of the CHK carton ±2
mAU.
• W1BS and W2BS: Refer to W1BS and W2BS service methods.
• RMS: Refer to RIMS method.
Keyboard System Check Map, useful for scheduling independent SC tests:
• DABS: <SHIFT + P9>
• RIMS: <SHIFT + P10>
• HABS: <CTRL + F1>

C Methods 101
• SABS: <CTRL + F3>

• PQC: <CTRL + F5>
• W1BS: <ALT + GGT> with HM Module.
• W2BS: <ALT + GLUC> with HM Module.
• SCHK: user must assign method key (see Dimension® Operators Guide).
Troubleshoot first any Photometer System Check failures before troubleshooting any other
coincidental Sytem Check problems. Photometric performace is primary to all other Sys-
tem Check tests and must be performing normally before correcting other problems.
NOTE Typically System Check performance will be better than

specification by a factor of two or better. Atypical perfor-
mance near specification limits is not desirable and should
not be tolerated as it usually indicates an incipient problem.
PQC Troubleshooting
PQC problems result from excessive variation between two blank photometer reads for the
same optical filter on a specific cuvette. The reads take place approximately 43 seconds
apart and generally indicate how well the photometer can reposition itself back to the center
of a specific cuvette window after movement to another window.
• Dirty cuvette windows.
• Cuvette wheel misalignment.
• Defective or malformed cuvettes.
• Defective, aged or incorrectly installed source lamp.
• Defective or dirty optical filter(s).
• Photometer misalignment.
• Thermal chamber insulation interference.
• Cuvette film not routed correctly through either film guide.
• Defective cuvette film.
• Foreign material stuck in the beam path (often the red film attachment adhesive tape).
• Photometer drive belt tension too loose or too tight.
• Damaged photometer drive belt.
• Photometer belt toothed gear ring loose on photometer casting.
• Photometer belt holding set curves from pulleys (replace or reposition belt to fix).
• “D” washer interference with log amp.
• Log amp mounted too high.

102 C Methods
• Excessive cuvette film tension drag, which pulls cuvettes backward after a cuvette
wheel index.
• Cable interference and tension.
• Photometer bearing needing lubrication.
• Loose optics in photometer (need additional wavy washer).
• Photometer offset alignment off by one count (software).
• Loose capstan drum on the cuvette film drive motor.
R1BS/ R2BS Troubleshooting
Accuracy
• Cuvette wheel/ windows, log, amp.
• Wrong coefficients.
• C-Term correction required see Service Bulletin.
• Ensure instrument is in CHK mode.
• Wrong Bottle Value entered for CHK lot.
Precision
• Fluidics, cuvette quality, ultrasonics.
• Defective syringes.
• Crimped or pinched tubing.
• Defective cuvettes.
• Overflowing wash drains.
• Worn reagent probe tip.
• Defective pump panel valve(s).
• Poor Ultrasonic mix.
• External fluid, usualy probe wash water or reagent tube condensate water, leaking into
cuvettes through the baseplate cuvette probe access holes.
SCHK Troubleshooting
• Ensure R2BS and R1BS are functioning properly.
• Run manual SABS to isolate sampler performance from R2 delivery to vessel.
Accuracy

C Methods 103
Precision
• R1 Arm delivers 345 µL of water to cuvette and mixes. If R1 is not perpendicular to
cuvette ultrasonic mixing can cause foaming.
• Misaligned sample probe to vessel and/ or cuvette.
• Worn Sample probe.
SABS Troubleshooting
• Ensure R1BS is functioning properly.
Accuracy
Precision
• R1 arm delivers 345 µL of water to cuvette and mixes. If R1 is not perpendicular to
cuvette ultrasonic mixing can cause foaming.
• Misaligned sample probe.
• Worn Sample probe.

104 C Methods
CHOL 4.5
Method Chemistry 0

3 PHOT READ 452/ 540/ 700 nm
Method Specifics 0
• Endpoint, polychromatic 452/ 540/ 700 nm.

• Allen correction used to correct for background absorbance.
• The CDC-National Lipid Standardization Program certifies the accuracy of the choles-
terol method with patient samples. The method accuracy is referenced to the
Abell-Kendall reference method. Certification is done every two years by Cholesterol
Reference Method Laboratory Network (CRMLN). A copy of the certificate is available
on DMS.
• The 540 nm filter is used for maximum absorption of the chromophone.
Troubleshooting 0
• If poor precision, check:

- Sample tubing for kinks, leaks, etc.
- Sample drain.
- Sample ultrasonics.
• Sample mix sensitive - no sample mix gives lower result by 13%.
• Increased cuvette temperature will increase the cholesterol value. Decreased tempera-
ture will decrease the cholesterol value.
• Replacing the 540 nm filter fixed a bias between two Dimension® systems.
• Low Bias is observed with most of the manufactured control products. This is related to
QC-matrix.
• NCEP has established standards for the precision, accuracy and total allowable errors.

C Methods 105
• For linearity validation use high and low human serum pools or commercial linearity
standards. Make sure triglycerides in these samples are less than 600 mg/dL [6.78
mmol/L].
• If tablet is not dissolved or is stuck under lidstock, may give below assay range and zero
values.

106 C Methods
CKI 4.6
Method Chemistry 0

1 R1ARM (R1) 112 µL, (H2O) 86 µL N
3 R2ARM (R2) 55 µL, 70 µL Y
Method Specifics 0

• IFCC standardized.
• Calibrated with CKI/ MBI (DC32).
• All liquid reagents.
• Sensitive to cuvette temperature.
• Sensitive to water temperature used to hydrate QC.
• Calibrators, QC product and smaples degrade quickly when left out at room tempera-
ture.
• No “subdepln” error flag exists. The “below assay range” error will occur on high errors
instead of “subdepln” error. The user should investigate if the error is from an extremely
low or high sample. Dilute one part of the sample with one part of QC or reagent grade
water.

C Methods 107
COC 4.7
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Cocaine, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance

108 C Methods

method.
Low ‘A’ Error

• Root cause:
High ‘A’ Error

Indicates that the final optical density (FOD) limit for hte mthod has been exceeded. Most
Abnormal Reaction
• Root cause:
Inaccuracy
insert sheet.
Imprecision

C Methods 109

• R1 probe.

110 C Methods
CRBM 4.8
Method Chemistry 0

5 R2ARM (R3) 80 µL, (H2O) 40 µL Y
6 PHOT READ hardread 340/700 nm
Method Specifics 0
• Pseudo-endpoint, bichromatic 340/700 nm.

• Flex type = 8 wells, all liquid reagents.
• Calibration type: logit.
• Turbidimetric - uses inner detection cell only.
• Inverse standard curve: the lower the mA, the higher the µg/mL result.
• As with all PETINIA methods, CRBM is a nonlinear method with five C terms. all terms
will change wiht calibration, except C4; C4 is 0.5.
• Dimension assay measures both the parent drug carbamezepine and its active metab-
olite carbamezepine- 10, 11-epoxide at greater than 90%.
• No significant cross-reactivity with Oxcarbazepine (Trileptol®).
Troubleshooting 0
• Arithmetic error message should not occur when starting with assigned coefficients in
insert. If Arithmetic Error is generated on recalibration, press calculate and accept the
new curve if acceptable calibration guidelines are met . Check QC.
• Make sure that reagent has not been frozen, either by the instrument or the refrigerator,
since this may alter Particle Reagent, and may cause gross imprecision.
• Sensitive to reagent and cuvette temperature. Calibrate reagent and cuvette tempera-
tures when troubleshooting accuracy issues.

C Methods 111
• If CRBM is last test ordered in a run, or is ordered individually, th instrument will blow 10
cuvettes in order to maintain proper temperature in the cuvette area.
• May be sensitive to photometer positioning. Make sure the wok insulation and photom-
eter cables are not interfering with the photometer. Lubricate the photometer bearing.
• Double punch is done on each well.
• Recalibrate if you replace source lamp, optical filter, or photodiode.
Error Messages
Abnormal Reaction - Check 700>100 mAU

Check for foaming, air bubbles or turbidity in the cuvette.
• Root Cause:
- Weak source lamp.
- Sample probe worn or misaligned.
- Sample mixing inadequate due to ultrasonics.
NOTE If a single patient sample is flagged with abnormal reaction

time error, analyze sample by an alternate method since it is
possible there is an interfering substance present in the sam-
ple.
Abnormal Reaction - nonsp>50 mAU

Check for non-specific aggregation prior to the addition of the antibody reagent.
• Root cause:
- Sample quality issues such as fibrin stands, clots.
- Sample probe misaligned or worn.
Absorbance - monoPR>1700 mAU

Check for particle reagent aggregation.
• Root cause:
- Particles aggregated on their own in Flex well.
Absorbance - Part 1<350 mAU

Check for the delivery of the particle reagent to the cuvette.
• Root cause:
- R1 probe tubing crimped.

112 C Methods
Below Assay Range

CRBM concentration below assay range.
• Perform a 50% recovery of known standard or QC material to confirm there was no
activity in the sample, and that there was no instrument malfunction.
• If the calculated sample concentration confirms the concentration to be < 0.5 µg/dL, the
result should be reported as “less than 0.5 µg/dL.”
Above Assay Range

CRBM concentration above assay range.
• Samples will be diluted by the instrument automatically if autodilute feature is config-
ured.
• Dilute sample with CRBM-free serum or DDRUGCII level 1, enter dilution factor.
Root Cause:
• Photometric issues such as weak source lamp and dirty cuvette windows.
• Sample mixing inadequate due to ultrasonics.
• Flex reagent exposed to freezing conditions.
Within-Lot Accuracy
Root Cause:

C Methods 113
CREA 4.9
Method Chemistry 0

1 R1ARM (R1) 74 µL, (R2) 18 µL, (H2O) 208µL Y
Method Specifics 0
• Increasing rate, bichromatic 510/ 600 nm.

• Bilirubin interference (insert claims no interference from bilirubin) - reagent has ferricya-
nide to minimize interference.
• Pyruvates, acetone, acetacetic acid (those with active methyl groups and reaction rates
comparable to creatinine) may cause interference with creatinine - may be observed on
patients with End Stage Renal Disease (ESRD) - 40% diabetics.
• Positive interference with cephalosporine.
• Acetone falsely elevates CREA results. Do not wash pipettes with acetone.
• R1 reagent is remixed prior to aspiration.
• Mixing of R1 and R2 forms crystals on lid stock which could plug probe tip. Revision 2.4
software adds a remix by the R1 probe to help break up these crystals.
• Air bubble is used to separate R1 and R2 in reagent aspiration (double-dip).
• No preservative is needed during specimen collection.
• Dimension® RxL/RxL Max non-HM Module: (see AUD for additional details)

114 C Methods
• Dimension® RxL/RxL Max/EXL/EXL with HM Module: (see AUD for additional

details)
dilution is performed using 100 µL Sample Syringe for sample aspiration and 2500 µL
ple to the cuvette.
• Dimension® Xpand® and Xpand® Plus clinical chemistry system: (see AUD for
additional details)
ric Cuvette, PUD (Photometric Urine Dilutions). The dilutions are performed using 100
µL Sample Syringe for sample aspiration and 500 µL R1 Metering Syringe for the dilu-
tion. The Photometric sample transfers the diluted sample from the First cuvette to the
second cuvette.
• Manual urine dilutions should be performed with Enzyme Diluent, not water. There is a
correction factor coded in the software for dilutions made by the instrument (to correct
for using water).
Troubleshooting 0
• No reagent mix will produce ~ 0.0 results (very low).

• The method is sample initiated and is susceptible to sample mix problems.
• Alignment of R1 probe to Flex® reagent cartridge is critical.
Result Monitor
Tab. 33 Limit Table

A 510/600 80 250 2.0 0.80 abnl Active
assay
B 452 80 250 1.00 1.00 abnl Active
assay

C Methods 115

CREA A on sample and reagents Check Li Picrate delivery by R1ARM
Back extrapolated from r2, r3
B on sample and reagents Check Li Picrate delivery to the
Endpoint at 452 for reagent cuvette by R1ARM
Final read (r3) Detects reagent crystals blocking R1

probe aspiration.
Normal is pegged at 2,000 mA
Mean 2,000 mA ± 0 typical

116 C Methods
CRP 4.10
Method Chemistry 0

1 R1ARM (R1) 284 µL, (H2O) 22 µL N
Method Specifics 0
• Turbidimetric, bichromatic 340/ 700 nm.

• Only method using R2 mix at power level “3” or “low”.
• Turbidimetric (inner cell detector only).
• Ultrasonic mix of R2 changed from level 2 to level 8 to improve precision.

C Methods 117
CSA (HM) 4.11
Method Chemistry 0

1 R2ARM (R3: Lysing reagent) 70 µL N
3 R2ARM (R1: Conjugate) 50 µL, (H2O) 40 µL Y
5 R2ARM (R2: CrO2) 50 µL, (H2O) 40 µL Y
6 MAGNET Chrome separation N
Cuvette (Sample Processing)

1 R1ARM (R4: CPRG) 150 µL, (H2O) 155 µL N
3 SAMPLE (Sample from vessel) 54µL, (H2O) 36 µL Y
Method Specifics 0
• CSA is processed on Dimension® RxL/ Xpand/EXL® platforms with HM only.

118 C Methods
• Requires the use of DF89A Flex® reagent cartridge.
Sample Integrity
• Use EDTA whole blood that is free of particulate matter and clots.
• Run in “limited Cup, No Level Sense” mode and “CSF/ Blood” as Fluid type. CSA will
not process primary tubes.
• To ensure optimum mixing and sample transfer, pipette 200 µL of sample into the cup;
pipette 300 µL of sample to request for 3-5 replicates.
• Too much sample in the cup may cause poor remix during ultrasonic and/or may cause
sample splatter.
• Lysing of red blood cells is performed by ultrasonic power in the presence of lysing
reagent.
• Specimen must be sampled within 30 minutes of placement on instrument.
Instrument Checks
• Check all alignments on the instrument (HM, Photometric Sampler, and Reagent 1
Arm).
• Reagent 2 arm is used extensively with this method.
• Check all alignments of the Reagent 2 arm.
• Ensure that the Reagent 2 probe tip is in good condition.
• Ensure that the Reagent 2 drain is clear and vacuum is within specification.
CSA Reagents
• Well 1, 2: Conjugate reagent
• Well 3, 4: 1 chrome tablet hydrated with 1900 µL
• Well 5, 6: 3 tablets of CPRG hydrated with 1400 µL diluent in well 7 plus 400 µL water.
• Well 7: CPRG diluent
• Well 8: Lysing reagent
Error Messages and Codes 0
Abnormal Reaction
The fixed foam error limit (“rg2Blank” error < 80 mAU) is designed to detect significant
transfer of chrome into the measurement cuvette. In addition, it will detect significant foam-
ing or turbidity from other sources. If this error is being triggered, the functionality of the
magnet and probe alignments should be checked.

C Methods 119
Result Monitor
Tab. 34 Limit Table

A 577/700 10 250 1.2 0.8 abnl Active
assay
B 700 10 250 2.0 0.4 abnl Active
assay

CSA A Reagent (CPRG+H2O)CPRG Check CPRG delivery by R1ARM.
End-point (r2), air blanked This reading is proportional to the
Bichromatic (577/700) amount of residual CPRG in the solution.
Detects problems related to CPRG tablet
Limits: Mean +20% or –10% hydration or delivery to cuvette (wells 5
and 6)
B Reagent and sample (CPRG + Spl. + H2O) This read checks for sample addition and
End-point (30r), air blanked = rA foaming. Abnormal assay error is gener-
ated if mA is outside the result monitor
Monochromatic (700) limits. Abnormal reaction error is gener-
Limits: Mean +30% or –30% ated if mA is less than 80.
Abnormal Assay (Result Monitor)

The CSA method also uses two result monitoring errors: Result monitor A (RM A) and
result monitor B (RM B).
• For RM A, a photometric reading is made on the measurement cuvette after the addi-
tion of CPRG but before the transfer step. The reading is proportional to the amount of
residual CPR in the solution. RM A is more effective than the CPRG well hydration QC
in detecting problems related to CPRG tablet hydration or delivery.
• For RM B, the foam measurement is tracked using the result monitor feature of Dimen-
sion® software. The limits, however, are tighter than the fixed foam error limit described
above. Result Monitor B errors may be addressed by aligning probes to eliminate
chrome carryover.
RM B is a 30-second hard read at 700 nm. If Result Monitor B limits are not met, an
“abnormal assay” error is generated. If RM B mAUs are <80, an “abnormal reaction”
error is generated.

120 C Methods
Precision
Major causes for CSA imprecision are:
1. Foaming in the reaction vessel after the R2 addition of conjugate may cause high or low
outliers. Foaming may be caused by:
a) Misalignment of R2 probe to HM wash wheel by as little as 4 steps.
b) Hyperactive or worn probes.
c) R2 arm losing steps.
2. Sampler misalignment may cause low outliers, often zero values.
a) Sample probe aligned too high will sample at or above the meniscus.
b) Older (worn) sampler handlers may bind and not travel down the full distance with or
without error messages. Replacement may be necessary.
c) Outliers caused by the sample handler will also occur on other ACMIA methods
(DGNA, CSAE, and T3) and photometric methods like MG.
Accuracy
Inaccuracy may be caused by changes in the temperature of the cuvettes.

C Methods 121
CSAE (HM) 4.12
Method Chemistry 0

1 R2ARM (R3: Lysing reagent) 80 µL N

1 R1ARM (R4: CPRG) 150 µL, (H2O) 155 L N
3 SAMPLE (Sample from vessel) 25 µL, (H2O) 70 L Y
Method Specifics 0
• CSAE is processed on Dimension® RxL/ Xpand/EXL® platforms with HM only.

• Requires the use of DF108 Flex®reagent cartridge
• Type ‘c’ method

122 C Methods
Sample Integrity
• Run in “limited Cup, No Level Sense” mode or SSC mode and “CSF/ Blood” as Fluid
type. CSAE will not process primary tubes.
• To ensure optimum mixing and sample transfer, pipette 200 µL of sample into the cup
or SSC; pipette 300 µL of sample to request for 3-5 replicates.
• Too much sample in the cup may cause poor remix during ultrasonics and/ or may
cause sample splatter.
• Lysing of red blood cells occurs due to the presence of lysing reagent.
• Specimen must be sampled within 30 minutes of placement on instrument.
Instrument Checks
• Check all alignments on the instrument (HM, Photometric Sampler, and Reagent 1
Arm).
• Reagent 2 arm is used extensively with this method.
• Check all alignments of the Reagent 2 arm.
• Ensure that the Reagent 2 probe tip is in good condition.
• Ensure that the Reagent 2 drain is clear and vacuum is within specification.
CSAE Reagents
• Well 1, 2: Conjugate reagent
• Well 3, 4: 1 chrome tablet hydrated with 1900 µL
• Well 5, 6: 3 tablets of CPRG hydrated with 1400 µL diluent in well 7 plus 400 µL water.
• Well 7: CPRG diluent
• Well 8: Lysing reagent
Errors and Message Codes 0
Abnormal Reaction
The fixed foam error limit (“rg2Blank” error < 80 mAU) is designed to detect significant
transfer of chrome into the measurement cuvette. In addition, it will detect significant foam-
ing or turbidity from other sources. If this error is being triggered, the functionality of the
magnet and probe alignments should be checked.

C Methods 123
Result Monitor
Tab. 36 Limit Table

A 577/700 5 250 1.2 0.9 abnl Active
assay
B 700 5 250 1.1 0.8 abnl Active
assay

CSAE A Reagent (CPRG+H2O)CPRG Check CPRG delivery by R1ARM.
End-point (r2), air blanked This reading is proportional to the
Bichromatic (577/700) amount of residual CPRG in the solution.
Detects problems related to CPRG tablet
Limits: Mean +20% or –10% hydration or delivery to cuvette (wells 5
and 6)
B Reagent and sample (CPRG + Spl. + H2O) This read checks for sample addition and
End-point (30r), air blanked = rA foaming. Abnormal assay error is gener-
ated if mA is outside the result monitor
Monochromatic (700) limits. Abnormal reaction error is gener-
Limits: Mean +30% or –30% ated if mA is less than 80.

The CSAE method also uses two result monitoring errors: Result monitor A (RM A) and
result monitor B (RM B).
sion® software. The limits, however, are tighter than the fixed foam error limit described
chrome carryover.
RM B is a 30-second hard read at 700 nm. If Result Monitor B limits are not met, an
“abnormal assay” error is generated. If RM B mAUs are <80, an “abnormal reaction”
error is generated.

124 C Methods
Precision
Major causes for CSAE imprecision are:
1. Foaming in the reaction vessel after the R2 addition of conjugate may cause high or low
outliers. Foaming may be caused by:
a) Misalignment of R2 probe to HM incubate wheel by as little as 4 steps (vertical or
horizontal).
b) Hyperactive or worn probes.
c) R2 arm losing steps.
2. Sampler misalignment may cause low outliers, often zero values.
a) Sample probe aligned too high will sample at or above the meniscus.
b) Older (worn) sampler handlers may bind and not travel down the full distance with or
without error messages. Replacement may be necessary.
c) Outliers caused by the sample handler will also occur on other ACMIA methods
(DGNA and CSA) and photometric methods like MG.
Accuracy
Inaccuracy may be caused by changes in the temperature of the cuvettes.

C Methods 125
CTNI/ LTNI 4.13
Method Chemistry 0
Tab. 38 HM Vessel Processing

1 R2ARM (R5: cro2) 25 µL, (H2O) 35 µL N
4 MAGNET Chrome separation

Tab. 39 First Cuvette (Sample Processing)

1 R1ARM (R2: fadp) 24 µL, (R1:apo) 24µL, (H2O) 242 µL Y
2 SAMPLE (Sample from vessel) 65 µL, (H2O) 25 µL Y
3 PHOT READ hardread 510/ 700 nm

Tab. 40 Second Cuvette (Blank Processing)

1 R1ARM (R2: fadp) 24 µL, (R1:apo) 24µL, (H2O) 332 µL Y
2 SAMPLE no Sample addition N

126 C Methods
Method Specifics 0
• CTNI and LTNI methods are identical except LTNI has lower put-up controlled by soft-
ware for low volume.
• LTNI is available only on Dimension® Xpand® instruments using software revision 6.1.1
and higher.
• CTNI Reagents
a) Well 1: 3 FADP tablets hydrated with 1635 µL of cascade diluent in well 7
b) Well 2: 3 APO tablets hydrated with 1700 µL of water
c) Well 3, 4: empty
d) Well 5: 1 chrome tablet hydrated with 1750 µL of chrome diluent in well 8
e) Well 6: Conjugate reagent
f) Well 7: Cascade diluent
g) Well 8: Chrome diluent
Troubleshooting 0
General Information
• Filter data obtained through XLink is essential in troublehsooting HM methods.
• For HM system Imprecision and Accuracy Troubleshooting refer to HM System trouble-
shooting CSB D-00023R.
• For Diagnostic Criteria refer to CTNI education package D-0234R and FAQ D-01171.
• For sample handling/ integrity refer to Technical Bulletin on Pre-Analytical Sample han-
dling. See D-0244, D-0234R, D-01170 and CSB D-0244.
General Rules
The CTNI method is susceptible to any variation in the instrument condition. Changes in
chrome, reagent blanks, bacterial contamination, alignments, optics and ultrasonics affect
the precision and accuracy of the CTNI method. Chrome precision is moitored with abnor-
mal assay flags. Water and reagent contamination are monitored with abnormal reaction
flags. Chem Wash contamination does not have a monitor but may be checked using chem.
wash test. Optics and mA recovery can be chedked using XLink and read one function.
Abnormal Assay
• Chrome precision is monitored using the result monitor feature.
• The “A” monitor will have an above mean factor of 1.19 and a below mean factor of
0.83. If the results monitor exceeds these limits an error code of “Abnormal Assay” will
be flagged on the report slip.
• The Result Monitor mean for CTNI is usually at least greater than 100 mAU with a typi-
cal SD of 5 or less.

C Methods 127
• Chrome imprecision can be caused by the loss of chrome during the chrome transfer
process, spray or splatter during ultrasonic mixing, or under dilution of the chrome in the
wash station. Visual inspection is helpful in locating chrome residue and evaluation of
XLink data is essential in troubleshooting abnormal assay and abnormal reaction
errors.
• HM system maintenance - clean/ replace wash probes.
• Wash efficiency - change mixers, change wash cassettes.
• Check alignments and perpendicularity of all probes.
Abnormal Reaction Errors

• The abnormal reaction flag on CR02 readings is set at 80-300 mAU. If greater than or
less than these limits, the result will flag abnormal reaction.
• Caused by reagent blanks greater than 130 mAU or less than 2 mAU.
• Review of XLink filterdata is essential in determining the cause of the abnormal reac-
tion errors.
• Elevation of the reagent blanks is most often caused by bacterial phosphatases, con-
tamination of the FADP well by the R2 probe, or reagent carryover from poorly function-
ing R1 drain.
• If reagent blanks within well trend high over time, check if this is normal aging of the
well:
- May be seen for low volume labs or labs who only run 5 days per week. Check nor-
mal mAU for lot in use example normal 38 mAU escalation of 20 to 30 mAU may be
normal aging of the well.
- If reagent blanks return to baseline (reagent lot dependent check MFG QC data) on a
new Flex® and if the mAU value escalates very quickly, doubling or tripling the base-
line this may suggest contamination of the reagent well by the R2 probe. Perform R2
probe and drain maintenance.
- If reagent blanks trends higher Flex® cartridge to Flex® cartridge without returning to
baseline (2 to 3 times baseline).
- This may suggest bacterial contamination. Refer to HM System Troubleshooting
CSB D-00023R, #3 Water/ Reagent Contamination.
• If one hgh reagent blank result:
- Check R1 system, R1 drain, and R1 tubing.
NOTE IF there is water contamination, consider Millipore Mainte-

nance.
Always check the reagent and sample probe cleaner bottles
and tubing. Is cleaner being pumped into the drains? The R1
does not have probe cleaner; the probe is rinsed with water
when in the R1 drain.

128 C Methods
Chem Wash Contamination
NOTE In most cases, contamination is within the hardware sys-

tem/fluidics of the Chem Wash system and not the fluid itself.
If the Chem Wash system is contaminated, the polished mAU of samples will trend down-
ward as the Chem Wash flushes the bacterial phosphates out of the system, with a corre-
sponding downwards trend in analyte results. The effects of this contamination can be
seen as soon as 30 minutes after Standby. To test for Chem Wash contamination:
• Have te HM system in standby for 30 minutes.
• Using either TSH or CTNI method, run a sample of Level 1 calibrator or freshly opened
Chem Wash as a patient sample (n=10) as XQC. Review the polished MAU on the fil-
terdata and look for a downward trend with corresponding downward trend in analyte
results. A downward trend indicates the need to decontaminate the Chem Wash sys-
tem. Repeat the Chem Wash test. If the problem returns within the month, it could indi-
cate a severe contamination problem. Consult with Global Product Support before
decontaminating again.
Dissolved Oxygen (dO2) Effects

Cascade methodology requires sufficient and stable (not changing) levels of dO2 content.
Changes of dO2 of 2 ppm between two measurements of Millipore® product water at two
points in time (not the same day) are suggestive that dO2 not stable and should be further
investigated. FT4 is the most sensitive Cascade method to changing dO2 levels. FT4
requires dO2 content as close as possible to 7.0 ppm. See Service Bullein D-00016, “Mil-
lipore Aeration System”.
Magnetic Efects
NOTE Generally, magnetic efects causing result outliers occur with

low frequency.
• Refer to Service Bulletin D-0067, “Magnetic Field Effects on HM Assays”, “Magnetic

Field Effects on HM Assays REVISED” to identify potential stray magnetic fields affect-
ing chrome in cuvette. A guideline is presented below to help with this identification.
• If present, stray magnetic fields are generally found in the baseplate area (near cuvette
position 22 and/or position 44) or from the HM module and/ or photometer/ cuvette
bearings.

C Methods 129
• HM module bearing ring: A study was perfomed to observe the effects of magnetism on
cascade methods (CTNI, TSH, FT4) by using a highly magnetized HM module bearing
ring.
- Sample used was Chem Wash for CTNI, TSH, DPSA, and L1 Cal-FT4.
- Conclusions:
- Greatest effect ovserved with CTNI and TSH.
- Minimal effect observed on FT4.
- When imprecision was observed, mAU “outliers” were always high as compared to
the mean of results of a non-magnetized HM bearing ring (“Before”).
- A magnetic effect was observed on TSH, CTNI polished mAU results; ranked in order
of magnitude. FT4 did not appear to be affected.
- Effect was observed with CTNI on Read 1 at 510 nm.
Baseplate Area: Guideline Filterdata Interpretation for Identifying Possible Stray

Magnetic Fields
Stray magnetic fields generally exhibit themselves by lowering the active cuvette, 510 nm
signal. this can be observed in the filterdata of zero level sample results as:
• Polished mAU on a zero sample is -3 to -8.
• Active is <Blank by 10 or more mAU’s on a sample with no analyte (Chem Wash or 0.00
patient results). Typically the Active-Blank = ± 5. This is generally systematic across
multiple (usually all) zero level samples.
• The Read 4 - Read 2 mAU is <12 on a sample with no analyte (Chem Wash or 0.00
patient samples). This is systematic across multiple zero level samples. Normally this
value us 20-30 mAU.
- Removing the chrome from the Flex® and replacing with water yields (Active=blank)
± 5.
• There are a few filterdata patterns which indicate that a stray magnetic field may be
present on the instrument.
Patient Accuracy Problems
Sample Handling
Refer to Technical Bulletin on Pre-Analytical D01170 and CSB D-0244.
If collected in a red top serum tube ask the following:
1. Was the serum tube permitted to clot for 30 minutes?
2. Was the tube centrifuged according to Collection Tube Manufacture IFU?

130 C Methods
NOTE If the sample had been stored in the refrigerator or freezer,

re-centrifuge before processing to eliminate fibrin and result-
ing chrome aggregation. Rerun after centrifugation.
Non-Specific Binding (NSB) Interference

Potential NSB samples are defined as a patient sample results that are repeatable, not
matching the clinical picture for AMI or associated coronary syndromes and obtain normal
results using an alternate methodology.
NOTE No immunoassay is completely free of these types of interfer-

ence. We strongly advise that all of the discordant sample
inquiries on the revised CTNI method be handled through a
Technical Solutions Center (TSC) Inquiry.
Heterophilic Antibody Testing
1. Refer to HM System troubleshooting CSB D-0308, Dimension® HM Methods NSB

Interference and D-0023.
2. Contact Global Product Support (GPS) prior to sample return to Technical Support Lab
(TSL).
QC Issues
MAS, Bio-Rad and More are the primary manufacturers of QC materials that are used for
cardiac marker quality control. Remember that the analyte form in most QC materials is dif-
ferent from that in fresh patient samples or calibrator. You may see agreement between
instrument systems with patient results but widely different values with QC materials.
If QC accuracy issues arise:
1. Follow the “Accuracy” guideline above to challenge instrument and consumable perfor-
mance.
2. Check to be sure that the QC materials were received, stored, and used in accordance
with the product insert sheets.
3. Test alternate QC vials or product from alternate QC vendors. Stored CAP samples or
human pools can also be tested as alternate samples on accuracy checks to prove if
bias is seen only on QC materials as a matrix problem or if the bias is across multiple
sample sources. This is helpful in isolating Flex® vs. QC vs. calibrator as the problem
source.
4. Alternate shipments of QC products can be obtained by working with each QC vendor's
troubleshooting assistance centers.

C Methods 131
NOTE The Troponin-I analyte in QC material is also affected by stor-

age and handling similar to the Siemens calibrator.
Method Imprecision
If the QC or patient samples are showing erratic precision on recovery begin by trouble-
shooting the instrument. Obtain XLink data.
Refer to STS SB D-00023R HM System Imprecision and Accuracy Troubleshooting.
Dimension® CTNI Calibration Troubleshooting
Calibration
• CTNI calibrator
- Follow the recommended procedure on the insert. Before use, thaw for a minimum of
one hour (not to exceed two hours). Mix the contents of the vial by inverting gently ten
times. Also refer to the stability of the CTNI calibrator. the calibrator is shipped frozen
and should be put in the freezer upon receipt. Once the vials are opened the
assigned values are stable for 24 hours when thawed, recapped and stored at 2-8° C.
Thawed, unopened vials are stable for five days stored at 2-8° C.
• Calibration:
- When setting up the calibrations ensure enough calibrator is in each sample cup. For
HM methods, all data points are required for the curve. NO errors can be incurred on
the calibration and no data points can be deleted. For HM methods the “Arithmetic”
error is common on the preliminary calibration print out. For HM methods, which are
logit methods, you must press the calculate key. After pressing the Calculate key, all
the data for all the data points will be displayed on the screen. For all HM methods
there is a different calibration scheme (different number of replicates at each level).
For CTNI there are four replicates at levels 1 and 2, three replicates at level 3, and
two replicates at levels 4 and 5. Review the calibration data for accuracy and preci-
sion. If QC is processed within the calibration, ensure that the calibration is accept-
able prior to reviewing the QC recovery. Suggest running QC after the calibration is
calculated and accepted.

132 C Methods
Result Monitor 0
Tab. 41 Limit Table
Rslt Mntr Optical Fil- Minimum Maximum Above Below Error Mes- Status
ters Reps Reps Mean Fac- Mean Fac- sage
tor tor
B 510/700 15 250 40 0.0 abnl assay active

C Methods 133

134 C Methods

A • Troubleshoot for chrome dissolu-
CTNI/LTN Chrome level at 700 nm tion/mixing (R2 probe/ultrason-
I ics) if results are low and trend or
Air blanked difference between shift to normal (expected).
chrome cuvette (test) and the cas-
cade cuvette (blank). • Possible sample handling issue.
- The chrome value may not be
Limit + 19% or - 17 %
outside the result monitor limit;
Typical chrome SD < 5.0 however it may be atypical
compared to all other values.
See D-01171, “Preanalytical
Variable on Performance” on
the Dimension® CTNI method
and D-0244, “Information on
Specimen Preparation and
Handling’ for the Dimension®
HM.
- Styletting of the wash probes
is part of weekly maintenance.
Frequent required styletting of
the wash probes (within a
week) and CrO2 SD results
trending from normal up to 5
after styletting are indications
that sample handling is an
issue.
- Review W1BS and W2BS SD
values on chem data file for
outliers above their accep-
tance limit red line on the
graph.
- If low chrome occurs on more
than one sample and dissolu-
tion of the tablet is not the
problem, consider the follow-
ing:
- check alignment of the wash
probes
- replace wash probes
- replaces cassettes
- replace HM tubing harness
- evaluate pump panel (tubing,
chemwash valve), tubing from
HM wash station cassettes to
the waste bottle, vacuum sen-
sor
- diluent / aspirate lines
Dimension® DCIN-B01.840.02.01.02 Page 134 of 390 reversed © Siemens, 2014
10.14 H DX GPS D - W1BS, W2BS is useful for Restricted
troubleshooting to detect prob-
lem in wash station area. Load
an ABS/CHK flex manually as
D Methods 135
5-
DBI
5D Methods
Method Chemistry 0

1 R1ARM (R1) 0 µL, (H2O) 260 µL N
3 PHOTO READ 540/ 700 nm
4 R2ARM (R1) 25 µL, air bubble Y
Method Specifics 0
• Endpoint, Bichromatic 540/ 700 nm.

• Type “b” method.
• Calibration type: Linear.
• Elimination of the need for C0 adjustment on DBI.
• Level 1 calibrator is not supplied. Customer supplies Clinical Laboratory Reagent
water.
• Required to use TBI/ DBI Calibrator, Catalog Number DC167.
• TBI/ DBI calibrator (DC167) is traceable to NIST SRM 916. A traceability document is
available in PSOH.
• Standard sample volume is 10 µL, there is no reduced sample volume.
• Auto-dilute volume is 5 µL.
• DBI measures direct-acting bilirubins, which are monoconjugated bilirubin (ß) and
deconjugated bilirubin (γ) and delta bilirubin (δ).
• Delta Bilirubin is a direct reacting fraction of bilirubin (albumin-bound) present in a vari-
ety of patients with hyperbilirubinemia and hepatobiliary disease.

136 D Methods
• Delta bilirubin is not found in healthy population or in patients with unconjugated hyper-
bilirubinemia, including Gilbert’s disease, neonates and patients with hemolysis. It’s
absence in neonates with physiologic jaundice and Gilbert’s disease suggests that the
ability to glucoronate bilirubin is essential for the formation of albumin-bound bilirubin.
• The large amount of delta bilirubin in patients with a wide variety of hepatobiliary dis-
eases suggests that impaired bilirubin excretions in addition to intact conjugating mech-
anism is essential for delta bilirubin to appear.
• Delta bilirubin may result from tight albumin binding of bilirubin photoisomers which
could accumulate along with bilirubin conjugates during cholestasis.
• Delta bilirubin is the slowest reacting bilirubin fraction in the total reaction.
• Delta bilirubin occurs widely in adult icteric sera especially elevated during sever
obstructive jaundice.
• In patients with clinical worsening and increasing total bilirubin, delta bilirubin ranged
from approximately 20-50% of the total bilirubin. Delta bilirubin constituted a higher per-
centage of total bilirubin (50-90%) during clinical improvement with decreasing total
bilirubin.
• Independent “hemoglobin” test report message for DBI.
• A ‘hemoglobin’ error message indicates the hemoglobin concentration in the sample is
greater than 50 mg/dL.
• Customers should not use the TBIL/ TBI and DBIL/ DBI methods interchangeably.
• Calculated Results.
- Indirect Bilirubin (IBIL) = TBI - DBI (Direct Bilirubin)
• There is no result monitor for the DBI method. This field in the methpar is used for the
“crit” calculation of the hemoglobin flag.
• “Below assay range” indicates result is below the analytical sensitivity. Check and ver-
ify the presence of sample and no instrument malfunction has been confirmed.
Troubleshooting 0
• CLSI “Linearity” guidelines, EP6 states the definition of the linearity, is a measure of the
degree to which a curve approximates a straight line.
• This is easily done by intermixing high and low pools of human serum samples/ pools.
• As per CLSI documentation, designated method standards and calibrators are not suit-
able for linearity study.
• For DBI methods, diluting heolysed samples does not reduce hemoglobin interference.
Global Product Support (GPS) does not recommend diluting samples for these pur-
poses. By dilution you are lowering trip point in the software to avoid “hemoglobin flag”.
The Hb interference is still present after dilution, same proportion.
• The DBI Flex® IFU allows the laboratory to report results with the “hemoglobin” test
report message using their discretion.

D Methods 137
• The Dimension® Operator’s Guide has been revised to allow laboratories to report
results accompanied by the “hemoglobin” test report message.
• A standardized letter is available in “documentum” for those customers who would like
to be able to report results accompanied by a “hemoglobin” test report message,
according to their laboratory procedures. The letter explains the hemoglobin flag and
allows laboratories to report results accompanied by the “hemoglobin” test report mes-
sage, according to their laboratory procedures.
• Carryover pairs: SIRO/ DBI, TP/DBI
Measurement Error
MEAS_ERROR may be generated on all patients and not QC. This happens if DBI calibra-
tion steps are not followed as described in the Operator’s Guide. Calibration must be
accepted to store “cal-base” which is required for patient calculations. Failure to use “fresh”
Clinical Laboratory Reagent water such as Purified Water Diluent may cause this error. If
MEAS_ERROR is obtained, repeat DBI calibration, ACCEPT and STORE the calculated
coefficients.
High Intercept After Calibration

The calibration slope should be 0.97 to 1.03 and the intercept should not be clinically sig-
nificant. The DBI calibration automatically adjusts the Level 1 to “zero”. The calculated
intercept may appear to be higher than expected. Assess the recovery of the calibrators for
accuracy.
Open Well Stability
Identifying Open Well Stability

See Flex® map below. Working diazotized sulfanilic acid (the diazo reagent) is prepared in
Wells 1, 2, 3 and 4 from well 5, 7 or 8. the prepared reagent is stable for 48 hours. the QC
should recover within 2 SD. If QC is drifting outside of +2 SD may be contributed by insta-
bility the diazo reagent. Obtain X-link filterdata as evidence to support this issue.
insert graphic here
Resolving Open Well Instability

Process sample(s) or QC using freshly hydrated well set (go to a new well set).
If this brings QC recovery to expected values compared to the old well set indicate reagent
instability. Do the following corrective maintenance procedures:
• Clean R2 drain and if RMS is present clean R3 drain as well.
• Check R2 probe for tightness and correct alignment.
• Check R3 probe for tightness and correct alignment if RMS is present.
• Replace R2 reagent tubing and if RMS is present replace R3 reagent tubing as well.
• Replace R2/ R3 drain tubing to the waste tubing harness.

138 D Methods
• Replace waste tubing harness to the vacuum bottle.

• Dispatch Service Engineer to replace vacuum pump and R2/ R3 drain.
• X-Link Filter data prior to doing maintenance and after maintenance to monitor the suc-
cess of maintenance performed.

D Methods 139
DGNA (HM) 5.1
Method Chemistry 0

1 R2ARM (R1: conjugate) 100 µL, (H2O) 40 µL N
2 SAMPLE (Sample) 30 µL, (H2O) 30 µL Y
3 R2ARM (R2: CrO2) 75µL, (H2O) 45 µL Y
First Cuvette

2 SAMPLE (sample from vessel) 60 µL, (H2O) 35 µL Y
Method Specifics 0
• ACMIA format, Separate chrome only, CPRG detection.

• Flex® type = 8 well
• Samples containing Digibind® may result in misleading digoxin values.
• No significant interference from Spironolactone (up to 3000 ng/mL) and Canrenoic Acid
(up to 1250 µg/L).
• Chrome (R2) is remixed in Flex® prior to aspiration.

140 D Methods
Troubleshooting 0
Error Messages
Abnormal Reaction - rA Check 700>60 mAU (700ck; t = 3)

Check for foaming, air bubbles, or turbidity.
Root Cause:
• Photometric issues such as dirty windows, weak source lamp.
• Sample probe tubing crimped.
• Sample probe ultrasonics.
Typical mAU values 700ck; t = 30s and 700ck; t = 60s are negative.
Below Assay Range

DGNA concentration below assay range.
If the calculated sample concentration confirms the concentration to be < 0.20 ng/mL, the
result should be reported as “less than 0.20 ng/mL”.
Above Assay Range

DGNA concentration above assay range.
Dilute sample with DGNA-free serum, enter dilution factor.
NOTE Autodilute feature is not available for this method.
Absorbance
The mAU at the measurement wavelength exceeded 2000.
Re-assay the sample. If the error reoccurs, it may be due to optical interference.
Imprecision
If high fliers and increased imprecision is observed at 0, then R2 mix is likely the issue.
Check the probe tip and alignment. If this is still an issue, the R2 transducer or ultrasonic
board may be the issue.

D Methods 141
DGNA (Non-HM) 5.2
Method Chemistry 0
First Cuvette (Pre-treatment)

1 R1ARM (R1:conjugate) 100 µL, (H2O) 40 µL N
3 R2ARM (R2:CrO2) 75µL, (H2O) 45 µL Y

1 R1ARM (R4) 175 µL, (H2O) 125 µL N
2 R2ARM (Sample 700 nm first cuvette) 60 µL, (H2O) 40 Y
µL
Method Specifics 0

• 700 nm check shows incomplete magnetic particle separation in addition to foaming, air
bubbles, or turbidity.
• Mehod will give “floating point exception” errors during calibratioin when magnet does
not energize.
• Method will give “abnormal reaction” errors if magnet does not actuate.
• Unique “cuvette to cuvette” liquid reagent transfer used only on DGNA.

142 D Methods
• Instument throughput may be reduced due to long PHOTO READ time.

• Cuvette-to-cuvette transfer.
• Separation module required. This is installed on non-HM instruments in the factory.
• A magnet attached to the photometer separates magnetic particles.
• Samples containing Digibind® may result in misleading digoxin answers.
• No significant interference from Spironolactone (up to 3000 ng/mL) and Canrenoic Acid
(up to 1250 µg/L).
Troubleshooting 0
Error Messages
Abnormal Reaction Errors

Identifying which area is causing the problem is best done by getting filterdata on the result
that caused the error.
Looking at the Polished Results section of filterdata:
Tab. 43 Normal Polished Results
Primary Secondary
24s rate 185.637 185.637
700ck; t = 30s -18.836 -18.836
700ck; t = 60s -13.718 -13.718
Testing the Magnet

From the Main Menu:
1. Press F7 Diagnostics
2. Press F1 Electromechanical
3. Press F5 Photometer
4. Cursor over to magnet (OFF) and press return until magnet (ON)
5. Check to see if CR12 on Pump Region Board is on.
a) If YES, then continue.
b) If NO, replace Pump Region Board.
6. Remove air line from right side of DGN Air Pump Assembly.
a) If air is escaping, continue.
b) If no air, replace air pump.

D Methods 143
7. Lower thermal chamber and remove air line from Magnet Assembly.
a) If air is escaping, remove or repair magnet assembly.
b) If no air, look for air line leaks or kinks.
R2 Probe TIP/ Alignments
Polished Results
Primary Secondary
24s 43.583 43.583
700ck; t = 30s 194.934 194.934
700ck; t = 60s -8.164 -8.164
Change and align R2 probe tip.
Below Assay Range Error

DGNA concentration below assay range.
If the calculated sample concentration confirms the concentration to be < 0.20 ng/mL, the
result should be reported as “less than 0.20 ng/mL.”
NOTE If this error is obtained on all samples, check if 700ck t = 30s

and t = 60s are > 1500 mAU. Suspect no magnet.
No Magnet or Magnet Not Fully Against Cuvette
Primary Secondary
24s rate 0.000 0.000
700ck; t = 30s 1770.853 1770.853
700ck; t = 60s 1770.853 1770.853
Above Assay Range Error

DGNA concentration above assay range.
Dilute sample with DGNA-free serum, enter dilution factor.

144 D Methods
NOTE Autodilution is not available for this method.
Imprecision
Check R2 reagent probe alignment, reagent tubing and probe condition.

D Methods 145
DGTX (HM) 5.3
Method Chemistry 0

1 R2ARM (R1: conjugate) 100 µL, (H2O) 40 µL Y
3 R2ARM (R2: CrO2) 75µL, (H2O) 45 µL Y

3 PHOTO READ 577/ 700
Method Specifics 0
• ACMIA Format, Separate chrome only, CPRG detection

• Reagents:
- Well 1, 2: Conjugate
- Well 3, 4: 1 T chrome
- Well 5, 6: 1 T CPRG
- Well 7: Ethylene glycol
- Well 8: Empty
• Chrome (R2) is remixed in the Flex® prior to aspiration.

146 D Methods
Troubleshooting 0
No problems seen.
Error Flags
• Chrome Detection.
• Abnl Reaction “cro2” > 60 mA. Check for cuvette foaming or Bad Cuvettes.
NOTE High results accompanied by high chrome numbers may

indicate incomplete separation of chrome. Ensure good sep-
aration occurs at magnet location. Examine cuvettes for
presence of chrome.

D Methods 147
DGTX (Non-HM) 5.4
Method Chemistry 0
First Cuvette (Pre-Treatment)

1 R1ARM (R1:conjugate) 100 µL, (H2O) 40 µL Y
3 R2ARM (R2:CrO2) 75µL, (H2O) 45 µL Y

1 R1ARM (R4) 175 µL, (H2O) 125 µL N
2 R2ARM (Sample from first cuvette) 60 µL, (H2O) 40 µL Y
Method Specifics 0

• Calibration curve logit.
• Cuvette-to-cuvette transfer.
• Separation module required. This is installed on non-HM instruments in the factory.
• A magnet attached to the photometer separates magnetic particles.

148 E Methods
6-
ECO2
6E Methods
Method Chemistry 0

1 R1ARM (R1) 100 µL, (H2O) 230 µL y
Method Specifics 0
• Enzymatic Carbonate.
• Negative-Rate, bichromatic 405/ 700 nm.
• Flex® type = 8 well, all liquid reagents
• 15 tests per well, punctured life = 2.0 days.
• Remember samples for CO2 readily decompose, losing CO2.
• Between day QC precision depend on stability of the QC materials. Open a fresh vial if
QC results shift low.
Troubleshooting 0
Within-run Precision
• Sample ultrasonics - poor mix. Poor mix can produce low results (40 - 50%).
• Check sample probe alignment to cuvette.
Accuracy
• Poor sample mix can produce low results (40-50%).
• Evaporation of sample will cause lower results: samples left more than 30 minutes on
the sample wheel can lower results (2 - 10 mmols).
• High results can be caused by reagent degrading. Check Result Monitor A mAUs for
abnormal assay errors. Only solution is to blow the well.

E Methods 149
Abnormal Assay Errors

• Mainly caused by environmental conditions - Result Monitor A - Low.
• Occur mostly in physician offices where room air is not refreshed. High levels of CO2 in
room air will cause substrate depletion of reagent. Only solution is to blow the well.
• Result Monitor B - Low.
• Sample mix causing foaming:
- Replace sample probe tip and align.
- Replace sample ultrasonics.
- Replace ultrasonics PC board.
Other
• Use ONLY deionized water to make dilutions.
• DO NOT use Calibrator Level 1 (contains 0.05 N HCL). HCL will vaporize dissolved
CO2, falsely depressing results.
Result Monitor
Tab. 44 Limit Table

A 405/700 30 250 1.12 0.88 abnl active
assay
B 700 45 250 2.0 0.10 abnl active
assay

150 E Methods

DBIL A Result Monitor A = rg1Blank = Check (R1) enzymes and NADH
mau1 delivery by R1ARM.
Reagent QC-1 Calculation: Check wells 1-6, all liquid reagents.
end-point (r2), air blanked, bichro-
matic (700)
Limits: Mean +12% or -12%
B Result Monitor B = rg2Blank = Check 700 absorbance after reagent
ch700 r4r3 and sample delivery.
Reagent QC-2 calculation: rate (r4 -
r3), air blanked, mono-chromatic
(700)
Result Monitor A checks for integrity, i.e., has the reagent been compromised?
Result Monitor B checks for foaming after sample addition.

E Methods 151
ETOH 6.1
Method Chemistry 0
Cuvette #1

1 R1ARM (R1) 225 µL N
3 PHOT READ 293/ 700 (sample addition check)
4 R2ARM (R2) 121 µL, (H2O) 60 µL Y
5 PHOT READ 340/ 383
6 PHOT READ 340/ 383
Method Specifics 0
• Rate, Bichromatic 340/ 383 nm.

• Modification of alcohol dehydrogenase (ADH) enzymatic procedure based on Syva
EMIT® II Plus reagents.
• No isopropanol (IPA) interference.
• Linear Method.
• Urine result is quantitative, no cut-off supported for qualitative use of method.
• Not qualified for whole blood.
• ADH reagent is homogeneous mixture.
Troubleshooting 0
• Analyte in sample is subject to evaporation; run as soon as possible after opening.

• Event # 3: PHOT READ (r4 in the methpar) is intended for sample addition check. It will
check if the sample is serum or plasma. The r4 read is currently not used in the calcula-
tion.
• ADH/ NAD reagents in wells 1 and 2 are not remixed prior to aspiration of the reagent.

152 E Methods
• Atmospheric ethanol can contaminate open wells.

• If contamination is observed then the Flex® can not be stored onboard. Add a new flex
when needed. The system will use the new well when the new Flex® is added.

E Methods 153
EXTC 6.2
Method Chemistry 0

1 R1ARM (R1) 245 µL N
2 SAMPLE 13 µL for 300 ng/mL cutoff, (H2O) 13 µL Y
8 µL for 500 ng/mL cutoff, (H2O) 13 µL
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Total Cuvette Volume: 396 µL for 300 mg/mL cutoff

Total Cuvette Volume: 391 µL for 500 mg/mL cutoff
Method Specifics 0
• EXTC DF109 qualified for urine only.

• EXTC DF109 suports two cutoff levels: 300 and 500 ng/mL.
• Syva EMIT® II Plus Ecstasy Calibrators are used to calibrate this method.
• Calibration guideline is ±10% only at the cutoff level for semi-quantitative mode. The
(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance

154 E Methods

method.
Low ‘A’ Error

• Root Cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
- Ghost Flex®.
Inaccuracy
Process five tests at the cutoff level. Mean should be ±10% cutoff level for semi-quantita-
tive and 975 - 1025 for qualitative.
drugs. Refer to Dimension® EXTC method insert sheet.
• Many cross-reactivity problems.

E Methods 155
Imprecision
Process 5-test precision study using cutoff levels. Evaluate agains SD claims.
• R1 probe.

156 E Methods
EZCR 6.3
Method Chemistry 0
Event # Event Cuvette Delivery Vol- Drain Delivery Volumes Mix

umes/ Filters
1 R1ARM (R3) 30 µL, (Air) 110 µL,
(H2O) 300 µL
2 R1ARM (R1) 110 µL, (H2O) 170 µL Y
5 R2ARM (R3) 30 µL, (Air) 10 µL,
(H2O) 300 µL
4 R2ARM (R2) 118 µL, (H2O) 20 µL Y
Method Specifics 0

• Flex® type = 6 well, HCI (Designated reagent R3) in wells 1 and 2, matched set of
reagents R1 and R2 in wells 3-6.
• Liquid reagents, no hydration required.
• Qualified autodilution volume for serum is 2 uL. Dilution is 1:3. No autodilution for
urines.
• Urines do not need a preservative.
• Pre-reagent wash command with HCI from the Flex® wells 1 and 2 with every R1 and
R2 probe reagent pickup.
• Requires software upgrades; Dimension® 7.4.5 or higher and for EXL® 9.2 or higher.
• All Dimension® models: (See for additional details)
Automated Urine Dilutions (AUD) for EZCR, 1:20 dilution is performed by in the First
Photometric Cuvette, PUD (Photometric Urine Dilution). The dilution is performed using
100 µL Sample Syringe for sample aspiration and 500 µL R1 Metering Syringe for dilu-
tion. The Photometric sampler transfers the diluted sample from the First cuvette to the
second cuvette.

E Methods 157
• Carryover Pairs: ACTM, EZCR; PHOS, EZCR; TP, EZCR
Troubleshooting 0
Precision
Causes of Imprecision
• Sample drain dirty or clogged.
• Sample tubing crimped or leaking.
• Poor photometric system.
• Extremely low dissolved oxygen content in water.
Result Monitor
Tab. 46 Limit Table

A 540 56 250 1.20 0.80 abnl Active
assay

EZCR Detects reagent delivery to Cuvettes 1. Repeat the sample. If the error
does not recur, the likely cause
would be a one-time event.
2. Align R1 probe.
3. Replace R1 tubing.
4. Evaluate condition of the optics
(lamp and windows).
5. Clean or replace R1 drain.

158 E Methods
Abnormal Reaction
700 check = Read 2 at 700 nm - Read 1 at 700 nm
If 700 check is >70, will generate Abnormal Reaction Flag.
Occurs after addition of reagent by R1 arm.
FATS (foaming, air bubbles, turbidity, scatter).
Troubleshooting
1. Clear turbidity from lipemic samples by ultracentrifugation.

2. Check tightness and alignment of R1 probe.
3. Replace R1 probe.
4. Replace R1 tubing.
5. Replace R1 500 µL pump panel tubing.
6. Replace R1 500 µL syringe.
7. Replace R1 valve solenoid.
EZCR is an Auto Urine Dilution (AUD) Method 0
NOTE PUD dilution protocol is used for the Enzymatic Creatinine

(EZCR) method on all Dimension® platforms.
PUD was used to standardize the urine enzymatic creatinine

patient, quality control and proficiency results across all plat-
forms. The 1:20 dilution was used to extend the urine mea-
surement range.
Correct Software Version is Required to Run the EZCR Method

• This is a 1:20 dilution with water when the sample is designated as “urine”.
• Two cuvettes are assigned for each test.
• The final sample dilution in the first-cuvette is 1:20.
• Uses sample/ reagent metering pumps.
• R1ARM fills first cuvette with 240 µL of water.
• R1ARM fills second cuvette with test reagents.
• SAMPLE arm always adds 15 µL of Urine sample + 45 µL of water to the first cuvette to
make 1:20 dilution and transferred to second cuvette by SAMPLE arm.
• The volume of the diluted-sample transferred to second cuvette is 6 µL.

E Methods 159

• Troubleshoot urine dilution errors using the PUD method guide.
Pre-Reagent Wash Command

This is a new system level feature for the Dimension® systems to wash the R1 and R2
probes prior to every EZCR reagent delivery. This is not currently performed with any other
method.The pre-reagent wash command must be included in the individual method meth-
par in order to be carried out (e.g. EZCR, see methpar commands below). This is not a cus-
tomized option. Howerver, this feature is now an available option for any future method
developments which may require a probe wash. The purpose of this wash is to remove any
potential reagent carryover on the probes from a prior reagent. This can be from prior
reagent delivery or from reagent hydrations perfromed prior to reagent delivery. This extra
pre-reagent wash command is necessary when rescheduling tests and normal probe
washes set up by the carryover pair violation feature is not adequate enough to prevent
reagent carryover.
The EZCR method is susceptible to reagent carryover from Cholesterol (CHOL) Accumu-
lation of Cholesterol (CHOL) reagent along with Automated High Density Lipoprotein Cho-
lesterol (AHDL). Automated Low Density Lipoprotein Cholesterol (ALDL), Total Protein
(TP), Phosphorus (PHOS), and Acetaminophen (ACTM) reagents on the probes exagger-
ates the interference. The extra cleaning step performed between carryover pairs is not
adequate enough to prevent carryover from CHOL into EZCR. Residual CHOL reagent on
the R1 arm probe is not completely removed. In the case of the R2 arm, CHOL reagent
hydration can leave residual CHOL reagent which also interferes. If this was to occur,
EZCR results would be falsely elevated. To prevent carryover issues that may result when
these tests are processed directly before an EZCR test the pre-reagent wash command
was developed.
EZCR Flex® Wells 1 and 2 Contain HCI at 0.5N Concentration 0
Before Each Reagent Delivery by R1 or R2:

• The pre-reagent wash command picks up HCI from the Flex® followed by an air slug.
• Dumps it down the drain.
• Followed by a wash with water.

160 E Methods
• Then the R1 or R2 probe picks up the EZCR reagents.
In the methpar you will see the following command comments:

{* Note that the R1 time for the 7.2 sec cycle instruments has been moved from -57.6 to
-56.0 sec, to accommodate for the HCI pre-reagent wash*}
-57.6 sec (XPANDL -77.7 sec): add 110 µL of R1/ 30 µL of R3 followed by 170 µL of water
{* The pre-reagent wash command below changes the above to: take the 30 µL R3
followed by 110 µL of air and pump it down the drain and wash with 300 µL of water,
then pick up 110 µL of R1 *}
Pre-reagent-wash air 110 µL water 300 µL
• ultra power = 3
• ultra ontime = 0.5 sec
• ultra duty cyle = 30%
• ultra cycle time = 105 msec
• ultra error rate = 40%
0.0 sec: add 6 ul of sample followed by 15 ul of water {*t.v.=301ul*}
• ultra power = 2
• ultra ontime = 0.5 sec
• ultra duty cycle = 20%
165.0 sec: read cuvette tag = “r2”
184.0 sec: add 118 µL of R2/ 30 µL of R3 followed by 20 µL of water

{* The pre-reagent-wash command below changes the above to: take the 30 µL R3
followed by 10 µL of air and dump it down the drain and wash with 300 µL of water,
then pick up 118 µL of R2*}
Pre-reagent-wash air 10 µL water 300 µL

• ultra power = 8
• ultra ontime = 0.5 sec.
• ultra duty cycle = 30%

E Methods 161
420.0 sec: read cuvette tag = “rc1”

435.0 sec: read cuvette tag = “rc2”
450.0 sec: read cuvette tag = “r3”
Calculations Associated with EZCR Method 0
New Dimension® software versions for EZCR have been updated to include EZCR in cre-
atinine calculations defined on the Dimension® system. CREA and/ or EZCR will work
when the calculations are ordered.
BUN/ Creatinine Ratio: (BN/EC)

BN = BUN, EC = EZCR
BN/EC = (BUM) (k) / EZCR

K = 1 if both results are reported in mg/dL
K = 1000 if BUN is reported in mmol/L and EZCR in µmol/L
NOTE This is a new equation. The original BN/ CR calculation refers

to BUN/ CREA ratio only. A new equation was necessary in
order to enter a BN/ EC reference interval.
Microalbumin/ Creatinine Ratio: (MA/CR)

MA = MALB and CR = CREA or EZCR
[MALB/CREA(EZCR)] X 100
MALB must be in the unit mg/L and CREA or EZCR must be in the unit mg/dL.
The MA/CR ratio is reported with the unit mg/g.

162 F Methods
7-
FERR
7F Methods
Method Chemistry 0

1 R2ARM (R2:CrO2) 30 µL, (H2O) 50 µL N
2 SAMPLE 40 µL, (H2O) 50 µL N
3 R2 ARM (R1:conjugate) 50 µL, H2O 30 µL Y
4 Magnet Chrome separation

1 R1ARM (R4: CPRG) 175 µL, (H2O) 125 µL Y
4 PHOTO READ hardread 577/ 700
Method Specifics 0
• Simultaneous format, CPRG detection.

• FERR reagents.
- Well 1: Conjugate reagent
- Well 2: Empty
- Well 3: 1 tablet chrome hydrated with 1750 µL of H2O
- Well 4, 5, 6: 2 tablets of CPRG hydrated with 1500 µL of diluent in well 7
- Well 7: CPRG Diluent
- Well 8: Empty

F Methods 163
• CRO2 range 40-125 (software 7.4.2 and higher).

• Rgt blank range 50-500.
Troubleshooting 0
The FERR method contains chrome and reagent flags. These flags are very similar to
those in the HCG and MMB methods.
Reagent Flags
• “rgt blank” error < 50 indicates low CPRG concentration in cuvette.
- If an isolated event, check for bad cuvettes or R1 probe fluidics.
- If multiple events, check for R2 probe coring, incomplete tablet hydration or too few
CPRG tablets (<2).
• “rgt blank” error > 500 indicates high CPR concentration in cuvette.
- Check for R2 coring, bad cuvette or foaming, reagent contamination or too many
CPRG tablets (>2).
Chrome Flags
Check filterdata to determine if Abnl reaction coded “cro2.”
• Abnl reaction “cro2” <40 indicates low chrome in cuvette.
- Check for chrome tablet in well, underhydration of chrome well, undissolved tablets,
R2 remix of chrome well, R2 chrome transfer to reaction vessel, chrome loss at wash
station (magnet and wash probe alignments), chrome clumping due to sample clot-
ting.
• Abnl reaction “cro2” >125 indicates high chrome in cuvette or foaming, etc.
- Check for correct number of tablets per well (1), underhydration of chrome well,
improper resuspension of chrome in reaction vessel. Also look for foaming in cuvette.
The cro2 flags are lower than those of the HCG and MMB methods. They were adjusted to
reflect the fact that the chrome concentration in the cuvette is lower in the FERR method.
Plasma Samples
Although the problem was not observed on the FERR method, during the MMB Field Eval-
uation at Columbia a significant imprecision problem waas observed. The problem was
traced to plasma samples that had been frozen and thawed. The clots in the samples were
clogging the wash probes resulting in poor washing and erroneous results. This problem
caused both erroneous high and low results. Once the material clogged the wash probes,
they had to be cleaned thoroughly to regain proper performance. All of the heterogeneous
module methods are sensitive to contaminants that may block the wash probes.

164 F Methods
Chrome and Substrate Tablet Hydration

The effect of over or underhydration of the Substrate or Chrome Tablets was examined by
dissolving tablets to either 50% or 150% of the normal value. The results show that a 50%
variation in chrome has very little effect on response. This is consistent with the optimiza-
tion data showing that the chrome is present in excess.
The volume of chrome in the well has been set high enough to maintain a large dead vol-
ume. This allows for an efficient remix of the chrome between runs. If the chrome tablets
are underhydrated the remix may not be efficient and the chrome per vessel may vary. This
is normally observed as a trending in chrome numbers across the well. If the underhydra-
tion is severe, the last tests from the Flex® will contain insufficient chrome, triggering the
low chrome flag.
Changes in substrate content have more effect. A 50% change in substrate concentration
results in about a 15-20% change in analyte. Unlike the chrome well, the substrate wells
do not contain a significant dead volume. Any significant underhydration of a well will result
in an early depletion of the substrate solution. This will cause low substrate concentrations
in the cuvetes, resulting in reagent blank errors.
The effect of missing or additional tablets was also examined. The following table shows
that an extra chrome tablet alters response by 10-15%. Obviously, if the tablet is missing,
no chrome will be present, resulting in low chrome errors. The presence of an additional
substrate tablet (3 versus 2), increases response by about 10%, while a missing substrate
tablet (1 versus 3) decreases response by about 30%.
FERR Calibrator Average %

Change
Level 1 Level 2 Level 3 Level 4 Level 5
Normal Volumes 0 24 148 476 1059 na
Chrome - 2 tablets 0 22 134 428 892 -11%
Substrate 1 tablet 0 17 108 347 727 -29%
Substrate 3 tablets 0 26 159 514 1158 +8%
Calibration Variation
Level 5 calibrator may under recover up to 5% because of magnetic field in the wash
wheel-system and not method issue. To minimize this effect, always schedule QC with cal-
ibration so that the level 5 calibrator sample will not be the last on the wheel.

F Methods 165
FPSA 7.1
Method Chemistry 0


4 PHOT READ hard read 577/700 nm
Method Specifics 0
• FPSA reagents:
- Well 1: Conjugate
- Well 2: Chrome diluent
- Well 3: 1 tablet chrome hydrated with 1800 µL of chrome diluent
- Well 4, 5, 6: 2 tablets of CPRG hydrated with 1800 µL of CPRG diluent in well 7
- Well 7: CPRG diluent
- Well 8: Empty
• CRO2 range: 50-150. Foam_Error; CRO2 check, abnormal reaction.

166 F Methods
• Reagent blank range: 50-500 Foam_Error; R1 reagent check, abnormal reaction.

• Sequential sandwich assay format, CPRG detection; bichromatic 577/ 700.
• Type ‘c’ method (required processing in HM module).
• Extended read (long/short) method.
• Extended read method (Level=4).
• FOD error will enable autodilute.
• If (R30D > 1999.9) = FOD error.
R30D = r3 (577) + 2000
• Autodilute volume = 6 µL.
Troubleshooting 0
Low-end Imprecision
• Troubleshoot suspected wash station problems per HM System Check Guide.
• This method is susceptible to magnetism (uncommon) resulting in low-end imprecision.
• Refer to SKB ID# SKB0023323 for troubleshooting assistance.
• Contact GPS for further assistance
CPRG Detection
Abnl reaction Indicates low CPRG concentration delivered to cuvette. If

“rgt blank” < 50 mA isolated event, check for:
• bad cuvettes
• R1 probe fluidics
If multiple “events” (i.e. well set), check for:
• coring (R2 probe tip - CPRG wells transfer hydrations)
• incomplete hydration, undissolved tablets
Abnl reaction May indicate underhydration of CPRG wells. Check for:
“rgt blank” > 500 mA • coring
• foaming in cuvette/ bad cuvette
• reagent well contamination
Polished filterdata for “rgt blank” must be checked to determine high/ low failure mode.

F Methods 167
Chrome Detection
Abnl reaction Indicates low chrome delivered to cuvette. Check:

“cro2” < 50 mA • chrome remix in reagent cartridge. R2 probe to reagent cartridge
• for chrome loss at wash station, wash probe alignments
• magnet locations for good chrome separation
Abnl reaction • Indicates high chrome delivered to cuvette
“cro2” > 500 mA • Undissolved chrome tablet
• Chrome well underhydrated
• Check proper functioning of mixers for chrome resuspension in
vessel
• Check sample probe to vessel alignment for chrome resuspension
in vessel
Polished filterdata for “cro2” must be checked to determine high/ low failure mode.
Accuracy
• FPSA is unstable in samples and most likely the cause of inaccuracy is testing of FPSA
after the sample was kept at room temperature for more than four hours. See insert
sheet for sample handling.
• Fibrin clot in sample. Centrifuge and repeat.
• Immunoassay methods are susceptible to “hook effect,” where excess antigen pre-
vents simultaneous binding of capture and detection antibodies. Dilute sample with
purified water and rerun.
Result Monitor
Tab. 48 Limit Table

A 700 15 250 1.2 0.80 abnl Active
assay

FPSA cr02 check, mono-chromatic 700 nm

168 F Methods
FT3 7.2
Method Chemistry 0
Reaction Vessel
Event # Time (seconds) Event Delivery Volumes/ Filters Mix

1 -1109.8 R2ARM R1 (Biotinylated-Ab) 25 µL, (H2O) 25 µL N
2 -927.3 SAMPLE (Sample) 15 µL, (H2O) 10 µL Y
3 -800.8 R2ARM R2 (T2-Chemibead) 25 µL, (H2O) 10 µL N
4 -534.5 R2ARM R3 (Sensibead) 37 µL, (H2O) 103 µL N
5 0 LOCI ARM LOCI read vessel (3 reads) -
Method Specifics 0
• LOCI® method, a homogeneous, sequential (competitive) chemiluminescent assay.

• FT3 method is only available on the Dimension® EXL™ system with LOCI® module.
• Flex® type = 8 well. All FT3 reagents are liquid; however, Chemibead and Sensibead
reagent wells are mixed by the instrument when the well is first punctured. Mixing is per-
formed by the R2 or R3 probe (RMS). Mixing is accomplished by aspirating 40 µL of
reagent from the well and then dispensing it back into the same well for a total of 51
times (referred to internally as “thumper mixing”). This process is performed automati-
cally when a new Chemibead or Sensibead well is punctured. Mixing of Sensibead and
Chemibead can be pre-programmed using the inventory/ hydration screen.
FT3 Flex® Configuration (8 well Flex®)

Well Reagent Reagent Form
1, 2 Streptavidin Sensibeads Liquid
3, 4 T2 Chemibeads Liquid
5, 6 FT3 Biotinylated-Ab Liquid
7, 8 Empty Liquid

F Methods 169
• Coefficients:
- C0 = 3990.0
- C1 = -4007.00
- C2 = -2.6
- C3 = 5.8
- C4 = 0.9
• FT3 method uses the LOCI THYR Cal (RC610A) for calibration. Level 1 is not included
in the LOCI THYR Cal carton. Calibrator levels 2-6 are used for calibration of the FT3
method. During calibration each calibrator level is analyzed for three replicates. The
FT3 method is a logit method, and the calculated slope (m) should be between 0.95 and
1.05. The intercept (b) should be 0.0 or clinically insignificant. The correlation coeffi-
cient (r) should be between 0.990 and 1.000.
• FT3 is an inverse (reverse) reaction. The first calibrator has the highest count and the
fifth calibrator has the lowest count.
• The assay range for the Dimension EXL FT3 method is from 0.50 to 30.0 pg/mL. The
FT3 method reports to 2 decimal places. Samples with results in excess of 30.00 pg/mL
should be reported as “/greater than 30.0 pg/mL”. Samples should NOT be diluted.
Samples with results less than 0.50 pg/mL should be reported as “less than 0.50
pg/mL”.
Troubleshooting 0
troubleshooting should start with checking R2 alignments/ fluidics, followed by sampler
alignments/ fluidics.
• XLink instructions can be found in the EXL™ with LM Service Guide. Chemdata file will
contain summarized FT3 QC data. LOCIDATA file contains LOCI® reads and module
level checks. Standard Dimension® filterdata holds no FT3 or LOCI® method informa-
tion. LOCIDATA can be obtained via the snapshot directory. Software versions 9.1 and
higher has the “get LOCIDATA” command, which will pull most recent LOCIDATA (simi-
lar to “get filterdata” command).
• Abnormal Reaction errors (abnl reaction) are generated when a sample produces a
Kcount 20% below the mean recovery of the level 6 calibrator. Frequent occurrence of
this error indicates either the wrong calibrator level run, or a reagent delivery issue with
the Chemibead or Biotinylated Antibody. If the error is specific to a single sample, the
sample should be diluted 1:2 with a sample that has a known concentration. If the sam-
ple does not recover appropriately, an interferrent should be suspected.
• Measurement Errors are generated when the low signal value (20% below the mean
recovery of level 6 calibrator) used to trigger the abnormal reaction error is missing.
This can occur if the calibration is processed but not accepted.

170 F Methods
• The LOCI® Read outline is composed of 3 distinct reads which occur in this order: 1)
Pre-read; 2) Assay read; and 3) Gain read. The Pre-read and Gain reads produce diag-
nostic information to identify a malfunctioning LOCI® detector, shutter, or light emitting
diode (LED). Both occur on an empty read chamber with no vessel present. For FT3,
the Assay Read is composed of three assay read cycles. For each assay read cycle,
the reaction vessel is illuminated for 500 msec, and after a 100 msec gate delay, the
chemiluminescent signal is collected for 1000 msec. Total signal, reported in
kilo-counts (Kcounts-found in the LOCIDATA file under the Primary Column with LEG-
END: FT3 signal), is the sum of the 3 assay read cycles in counts/ 1000.
Results Monitoring
• The FT3 method uses the ReadVF as a result monitor, this is found in the LOCIDATA
file in the column ASY TOT VF. ASY TOT VF is the sum of the three ASY VF Rd. The
ReadVf measures the amount of light from the LED that gets detected by the illumina-
tion photocell. This read occurs when the sample reaction vessel is in the LOCI®
reader. An unusually high ReadVf occurs when there is no or a drastically reduced
amount of sensibead reagent in the assay. The methpar is set up to create an “Abnor-
mal Assay” error in this case. Likewise, a low ReadVf can occur if the sensibeads have
settled and are not sufficiently re-suspended during the thumper mix routine.
• The ReadVf for an assay is specific for a given instrument and may also vary with the
reagent lot or change after major work on the instrument. Therefore, results monitoring
is required to reliable detect this type of error. The first 15 results with a new Flex® lot or
calibration are averaged and the 16th result is the first to be checked with the results
monitor. It passes if it is within +/- 15% of this average and is then included in the aver-
age. After a total of 50 tests, the running average over the last 50 passing results is
used.
• The ReadVf running mean and calculated high and low acceptability limits can be found
in the LOCIDATA file. These are found in the primary column to the right of the follow-
ing legends: tVFR mean, tVFR sd, lo limit, and high limit.
• Abnormal Assay Troubleshooting for FT3 should include checking R2 and R3 align-
ment to Flex®, followed by R2 and R3 fluidics.
Contamination Read
• The contamination read occurs after the illumination LEDs have been fired during the
pre-read. The contamination read should normally show the noise floor of the reader.
This read can be found in the LOCIDATA file under column Contamination. The con-
tamination value is typically below 45 counts. If a contamination read exceeds accept-
able limits it will produce Error 849- Failed Reader Contamination Check, and the test
will not process.
• Should the system flag a contamination error, the LOCI® vacuum cup should be
replaced along with the LOCI® insert and retainer rubber seal. LOCI® arm alignments
shouldbe performed following replacement. Prior to replacing the vacuum cup, insert
and retainer seal, the HM incubation wheel should be examined to ensure there is no

F Methods 171
reagent spillage that could contaminate the vessel. Close examination should also be
done in the R2 delivery area. Should there be any stray fluids, cleanup should be per-
formed along with realignment of the R2 arm.
Illumination Read
• The illumination read is a measurement taken with the illumination photodiode of the
illumination LED banks function at the beginning of the pre-read. Acceptable range of
the illumination read is between 150,000 and 500,000 counts. The illumination read
appears in the column Illumination in the LOCIDATA file. If the value is greater than 7
standard deviations it must be within 1% fo mean. If the illumination read exceeds
acceptable limits it will produce Error 850- Failed Reader Illumination Check.
• Over illumination failures may be caused by:
- Noise related to electrical components, inspected to ensure cable routing is correct. If
problem persists change LOCI® board followed by the reader. If noise in the illumina-
tion value is found and corrected the LOCI® statistics file should be reset.
- Combination of instrument LOCI® reader sensitivity and reagent lot reactivity. If
errors started with new lot of reagent contact CCC/RSC. Do not replace parts.
- Patient samples have not caused over illumination errors because FT3 is a reverse
curve. It is very rare to have a patient sample with a near zero FT3 value.
Gain Read
• The gain read is taken after the method read. During the gain read the CPM response to
the gain LED is referenced to the gain photodiode measuring the same signal. Three
values output into the LOCIDATA file. These are GAIN TotCPM, GAIN Tot VF, (the sig-
nal as measured by the gain photodiode), and the ratio of the two or Relative Gain.
Acceptable Relative Gain ratios are between 1.0 and 8.5. Values must also be within
4% of the running mean and 5 standard deviations.
• The Relative Gain ratio can be used as a CPM drift monitor. Gain ratio should not drift >
1.0% over the course of a month. If a customer complains of a QC trend over time or
complains of not meeting the claimed calibration interval, the Relative Gain ratio should
be checked. Take the mean of the Relative Gain ratio reads from Day 1 and compare
with the mean of Relative Gain ratios from Day 30.
• Gain read errors typically stem from two issues. Most issues will occur as the result of a
semi/ nonfunctional shutter. Next, as normal CPM signal response degrades over time
the CPM may have truly fallen out of its usable life, and have a Relative Gain ratio of
below 1.0 (this however, should not happen for years of use). Persistent gain read
errors or significant CPM drift would necessitate replacement of the reader.
Non-delivery of Reagents or Sample

• Completely missing Bio-Ab reagent eliminates the specific signal and is expected to
result in significant signal loss. When FT3 signal is significantly lower than the level 6
calibrator signal the FT3 result cannot be calculated. The signal will be extremely low;
below 1 kilo-count and an “above assay range” or “assay range” test message will be

172 F Methods
reported. Non-delivery of Bio-Ab reagent should be flagged by an “assay range” test

message. Partially missing Bio-Ab is not easily identifiable. The amount of signal loss
depends on the fraction that is missing.
• Completely missing Chemibead reagent eliminates the specific signal and most of the
background and is expected to result in significant signal loss. When a FT3 signal is sig-
nificantly lower than the level 6 calibrator signal the FT3 result cannot be calculated.
The signal will be extremely low; below 1 kilo-count. Non-delivery of Chemibead
reagent should be flagged by an “abnormal reaction” test message. Partially missing
Chemibead reagent is not easily identifiable. The amount of signal loss depends on the
fraction that is missing.
• Completely missing Sensibead reagent eliminates the specific signal and most of the
background. Signal will be extremely low; below 1 Kilo-count. Non-delivery of sensi-
bead reagent should be flagged by an “abnormal reaction” message - see results moni-
toring section above.
• Completely missing sample eliminates the specific signal and results in a signal higher
than the zero level calibrator signal and the FT3 result cannot be calculated. A “Below
Assay Range” test message will be reported. Partially missing sample is not easily
identifiable.
Water is Substituted for Level 2 Calibrator

• FT3, TSHL and FT4L use LOCI® Thyroid Calibrator (RC610A). FT3 and TSHL use
Level 2 as their zero-level calibrator. FT3 uses calibrator Levels 2-6 to calibrate. Given
that the FT4L method uses water (Level 1) as its zero-level calibrator, a customer could
inadvertently substitute water instead of Level-2 calibrator during a FT3 calibration.
Water produces signal higher than Level-2 calibrator. Calibration curve fit and QC
recovery using water will most likely be acceptable. Using water for calibration will have
the greatest impact on analyte values less than 2.00 pg/mL. Low-end results would be
slightly inflated.

F Methods 173
FT4 7.3
Method Chemistry 0

1 R2ARM (R4: cro2-dil) 18 µL, (R5: cro2) 32 µL, N
(H2O) 105 µL
3 INCUBATE/ WASH Incubate/Wash/Separation/Rinse (150 µL)
Total Vessel Volume: first incubation: 250 µL; second incubation: 100 µL

1 R1ARM (R2: fadp) 40 µL, (R1: apo) 28 µL, (H2O) 212 µL Y
3 PHOT READ hardread turbidimetric 510/700 nm

174 F Methods
Second Cuvette (Blank Processing)

1 R1ARM (R2: fadp) 40 µL, (R1: apo) 28 µL, (H2O) 292 µL Y
2 SAMPLE No sample addition N
Method Specifics 0
FT4 Reagents
• Wells 1, 2: 3 FADP Tablets hydrated with 1635 µL of well 7
• Wells 3, 4: 2 APO Tablets hydrated with 1273 µL of water
• Wells 5: Chrome Diluent
• Well 6: 3 Chrome Tablets hydrated with 695 µL of well 5 and 1092 µL of water
• Well 7: Cascade Diluent
• Well 8: Conjugate Reagent
FT4 Reaction
The FT4 method uses 2 immunological reagents and the Rabin Cascade alkaline phos-
phatase detection system.
1. Chromium Dioxide: The chrome reagent contains covalently bound anti-T4 antibody.
The chrome tablets are dissolved in a method-specific chrome diluent. The hydrated
reagent contains buffers, salts, protein, detergents and preservatives.
2. Conjugate: The conjugate reagent consists of T3 bound to alkaline phosphatase. This
reagent also contains protein, buffers, salts and preservatives.
3. The alkaline phosphatase colorimetric detection system uses the Rabin Cascade.
These reagents are the same as used in the TSH and Troponin methods. The concen-
tration of the FADP reagent is higher in the cuvette to promote assay precision.

F Methods 175
Reaction Scheme (Sequential Format, Cascade Detection)
1. First incubation: Chrome added to reaction vessel followed by sample. Sample and
chrome reagents are incubated for 4.3 min at 37°C in a reaction vessel. During this
period, T4 in the sample is captured by the chrome-antibody reagent in proportion to
the free T4 content of the sample.
2. The first mixture is washed 3 times by the RxL Wash Station. The fluid phase is dis-
carded and the chromium dioxide solid phase further reacted.
3. Second incubation: Conjugate is added to the washed chrome-antibody-T4 complex,
and reacts with free chrome-antibodies in a 3.3 min incubation period at 37°C.
4. The second mixture is washed 3 times by the RxL Wash Station. Wash probe 2 MUST
deliver Chem Wash precisely.
5. The washed chrome-antibody-T4-conjugate complex is sampled into a cuvette contain-
ing Rabin Cascade alkaline phosphatase detection reagents. 6 cuvettes are formed, 2
cuvettes are used.
6. Color formation is measured over a 3.7 minute period, using a reagent blank and
bichromatic timed measurements.
7. Free T4 concentration is inversely proportional to color produced, and is estimated
through use of a 5-point calibration curve using a weighted logit equation.
8. Assay error flag order is important. FOD is lowest priority, others equal.
Reaction Monitor
Tab. 50 Limit Table

A 700 15 250 1.13 0.87 abnl Active
assay

176 F Methods

FT4 A True chrome level at 700 nm Determine if the Abnormal Assay is
Air blanked difference between chrome caused by high or low chrome (CrO2)
cuvette (test) and the cascade cuvette (blank). High chrome, suspect:
Limit ± 13% • Under-hydration, R2 fluidics
• Poor chrome remix, R2 ultrasonics
• Overactive R2 probe
• Bubble in light path, R1
• Low cuvette volume, sampler or R1
• Clogged Chem Wash (CW) dispense
probes or faulty pumps
• Sample (clot, fibrin particulates)
Low chrome, suspect:
• End of well, R2 alignment or fluidics
• Drips on Flex tray cover, R2 fluidics
• Splash on Plexiglass shield, mixers
• Drips on baseplate, sampler fluid-
ics/ultrasonics
• Sample (clot, fibrin particulates)
• Low chrome caused by high blanks
(elevated 700 nm reads 4, 5, 6 or 7)
- Foaming, R1
- Optics, dirty windows, source
lamp, photodiode
Troubleshooting 0
General Rule
In general, the FT4 method is the most susceptible method to variation or deterioration of
the instrument condition. Changes in chrome, blank values, dO2 content, alignments,
optics and ultrasonics all affect the precision and accuracy of this method. Chrome preci-
sion is monitored with Abnormal Assay flags. Water and reagent contamination is moni-
tored with Abnormal Reaction flags. Chem Wash contamination does not have a monitor
but may be checked using a Chem Wash test described below. Optics and mA recovery
can be checked using the x-link function.

F Methods 177
Troubleshooting
Analyze in the Following Order:
1. Windows and Source Lamp
2. Chrome
3. Water Reagent Contamination
4. Chem Wash Contamination
5. Dissolved Oxygen (dO2) Effects
6. Magnetic Effects
7. Inaccuracy
Windows and Source Lamp
• Review the data from the Read One Macro. Visually check the values to see if the indi-
vidual mAU values agree with the calculated mean and SD. Guideline Limits: Mean val-
ues should be 200 ±20, SD should be less than 5. Review all data and not just the final
SD provided at the bottom of the Read One Macro, there may have been a change due
to maintenance performed.
• If the Read One mAU values are intermittently or consistently high and/ or the SD is >
5.0, most likely the windows are dirty or the source lamp is bad.
• If the Read One mAU is consistently low (<180) or the SD > 5.0, most likely the lamp is
bad or it could also be dirty windows.
• For source lamp replacement, see Service Bulletin RxL-83, “Source Lamp Replace-
ments Requirements”.
Chrome
Chrome Abnormal Assay Errors
Precision of HM cascade methods is dependent on precise transfer of chrome particles
and good optics. Chrome imprecision can be caused by the loss of chrome during the
chrome transfer process, spray or splatter during ultrasonic mixing, under-dilution of the
chrome in the wash station, or mathematically when the blank reagent value is imprecise.
A combination of using your eyes to locate chrome residue and evaluation of x-link data is
required to efficiently troubleshoot Abnormal Assay flags. Abnormal Assay errors are
caused by chrome values outside the result monitor limit of 13%. Typical chrome precision
is < 5.0 SD. If the chrome values on the X-link data are imprecise (noisy):
• Check sample for clots and fibrin.
• Check wash station, incubation wheel, baseplate and Reagent Tray cover for splash-
ing.
• Check for bent or bad reaction vessel clips.
• Check for dirty or bad reaction vessel mixers.
• Check wash station alignment.
• Check for cleanliness of the wash probes.
• Check Sample and R2 alignments.

178 F Methods
• Clean drains and check sample and prove wash delivery.

• Check for crimps in tubing or loose tubing (R2 and Sample).
• If chrome first result is high or low, suspect chrome dissolution/ mixing.
• Check R2 ultrasonic alignment. Ensure ultrasonics are firing correctly, especially after
the system is in standby mode for a long time, such as a weekend.
Chrome Flags
If chrome value is above the FT4 Result Monitor limit, suspect sample probe to vessel
alignment, chrome under hydration, chrome remix problem, clogged wash probe or bub-
bles, foaming, poor cuvette, low cuvette volume, overactive R2 probe, sample handling
causing clumping from fibrin and/ or particulates in the sample.
• If below the FT4 Result Monitor limit suspect sample handling causing clumping from
particulates in the sample.
• Additional causes for FT4 Abnormal Assay Flags:
- It has been observed that the reagent blank cuvette (APO and FADP) can cause
Abnormal Assay errors. A reagent blank problem often is associated with an inverse
True/ Active chrome ratio. Two causes have been identified:
R1 probe not aligned or not perpendicular in the cuvette, causing foaming.
Optical problems due to lamp, photodiode or photometer.
- To determine the cause of the Abnormal Assay flag use the following criteria:
Suspect optics if:
- Consistent elevation of read 5 and 6 above the read 4 (second cuvette air blank).
- Both True and Active chrome values are elevated and the ratio is flipped.
Suspect R1 if:
- Reads 5 and 6 are randomly elevated above read 4 (second cuvette air blank).
- Only True chrome values are decreased and True/Active ratio is flipped.
Chrome Processing Assays
Three methods were used during HM development for troubleshooting chrome issues:
CRQC (Chrome QC), CRCV (Chrome to Cuvette), and CRRS ( Chrome Re-Suspension).
They are included in the commercial software without the need of passwords. The primary
advantages of these methods are:
• They use only the chrome from the Flex®.
• Much shorter assay time (about 50%) than standard TSH/FT4 methods.
• They do not require a sample.
Water/Reagent Contamination
System water contaminated with microbes contains phosphatase enzymes. These
enzymes act like the conjugate (alkaline phosphatase) and will cause the blank rate to
increase. The rate of increase is slower than seen with R2 probe contamination.

F Methods 179
• Very low mA (< 2 mA) may indicate missing tablets or non-hydration (coring by R2 dur-
ing hydration).
• Review XLINK blank results for the following: An abnormal reaction error message
occurs if blank readings are FT4 > 110. Blank results normally increase a small amount
as the reagent well ages. It can increase as much as 20 to 30 mAU during the three-day
life of the reagent well. Typical is 10 to 15 mAU. an increase of 30 mAU above the man-
ufacturing release blank data may indicate contaminated water or a contaminated
reagent well. The manufacturing release blanks are typically 15 to 30 mAU.
• Reagent Contamination: Rapid elevation above manufacturing Blank value +30 mAU,
typically observed immediately or within 1 day.
Corrective Actions (in the following order):
- Ensure that Probe Cleaner is not empty and is flowing to the drain.
- Clean (Clorox) and align the R1 and R2 drain and the R1 and R2 probe (clean with
reagent probe wash).
- Change R1, R2 probe; change R1, R2.
• Bacterial Contamination - Water: Steady rise of Blank above manufacturing Blank value
+ 30 mAU over a 3 day period. Gross bacterial contamination may start out (upon
hydration) above manufacturing Blank value + 30 mAU and continue to rise over the 3
days, or exceed 100 mAU within one day.
Corrective Action: If this is the first case of contamination, decontaminate both the
water system and the Chem Wash system. If this is not the first case, decontaminate
the water system back to the Millipore. If decontamination was performed during the
past month, consult Global Product Support before decontaminating again.
Chem Wash Contamination
NOTE In most cases, contamination is within the hardware system/

fluidics of the Chem Wash system and not the fluid itself.
If the Chem Wash fluidics system is contaminated, the polished mAU of samples will trend
downward as the Chem Wash flushes the bacterial phosphatases out of the system, with
a corresponding downwards trend in analyte results. The effects of this contamination can
be seen as soon as 30 minutes after Standby. To test for Chem Wash contamination:
• Have the HM system in standby for 30 minutes.
• Using either TSH or CTNI method, run a sample of Level 1 calibrator or freshly opened
Chem Wash as a patient sample (n=10) as XQC. Review the polished mAU on the fil-
terdata and look for a downward trend with corresponding downward trend in analyte

180 F Methods
results. A downward trend indicates the need to decontaminate the Chem Wash sys-
tem. If the problem returns within the month, it could indicate a severe contamination
problem. Consult with Global Product Support before decontaminating again.
Dissolved Oxygen (dO2) Effects
Cascade methodology requires sufficient and stable (not changing) levels of dO2 content.
Changes of dO2 of 2 ppm between two measurements of Millipore® product water at two
investigated. FT4 is the most sensitive Cascade method to changing dO2 levels. FT4
requires dO2 content as close to equilibrated water as possible. Typically this is a value of
7.0 ppm to 8.0 ppm. See Service Bulletin D-00016, “Millipore Aeration System.”
Magnetic Effects
NOTE Generally, magnetic effects causing result outliers occur with

low frequency and have minimal effect on FT4.
• Refer to Service Bulletin D-00067, “Magnetic Field Effects on HM Assays”, “Magnetic

Field Effects on HM Assays REVISED” to identify potential stray magnetic fields affect-
ing chrome in the cuvette. A guideline is presented below to help with this identification.
position 22 and/ or position 44) or from the HM module and/ or photometer/ cuvette
bearings.
• HM module bearing ring: A study was performed to observe the effects of magnetism
on cascade methods (CTNI, TSH, FT4) by using a highly magnetized HM module bear-
ing ring.
- Sample used was Chem Wash for CTNI, TSH, DPSA and L1 Cal-FT4.
- Conclusions:
• Greatest effect observed with CTNI and TSH.
• Minimal effect observed on FT4.
- Data is presented in Appendix 3, 4 and 5.

F Methods 181
Baseplate Area: Guideline Filter data Interpretation for Identifying Possible Stray
Magnetic Fields
• Stray magnetic fields generally exhibit themselves by lowering the active cuvette, 510
nm signal. This can be observed in the filterdata of zero level sample results as:
- Polished mAU on a zero sample is -3 to -8.
- Active is < Blank by 10 or more mAU’s on a sample with no analyte (Chem Wash or
0.00 patient results). Typically the Active- Blank = ±5. This is generally systematic
across multiple (usually all) zero level samples.
- The Read 4 - Read 2 mAU is <12 on a sample with no analyte (Chem Wash or 0.00
patient samples). This is systematic across multiple zero level samples. Normally,
this value is 20-30 mAU.
• Removing the chrome from the Flex® and replacing with water yields
(Active=blank) ±5.
- There are a few filterdata patterns which indicate that a stray magnetic field may be
present on the instrument. These are displayed in Appendix 8.
• You will notice from these graphs atypical shifts in mAU at the second and third
photometric reads. This is indicative of possible stray magnetic fields in these areas
of the instrument (cuvette position 22 and/ or 44 for RxL).
- These recommendations are only guidelines that may suggest acquiring a gauss
meter from second level support to identify if a stray magnetic field may be present on
the instrument.
- A gauss meter should be used to identify Magnetic effects on HM assays. See Ser-
vice Bulletin D-00067, “Magnetic Field Effects on HM Assays.”
- Representative data with HM Module bearing magnetism present and absent is dis-
played in Appendix 3. Also included are the specifications with failed data highlighted
in bold.
Inaccuracy
The most common cause of inaccuracy of FT4 is changes in the mA values since the time
of calibration. The most common cause of these mA changes is the dO2 content.
• Changes in the dO2 content of the water from the time of the calibration will change the
calibration curve causing a shift in accuracy. If the water dO2 content changes call RSC
to decide on the corrective action.
• If the calibrator 2 mA is 50 mA below the manufacturing mean mA value, check the dO2
content of the Millipore® product water. Laboratories at elevation above 2000 feet will
recover lower mA values. Check with RSC to interpret dO2 content readings.
• Conjugate exposed to elevated temperatures will deteriorate faster.
The FT4 method requires calibration every 30 days.

182 F Methods
FT4L 7.4
Method Chemistry 0
Reaction Vessel
Event # Time Event Delivery Volumes/ Measurement Mix

1 -720.4 sec R2ARM R1 (Biotinylated-Ab) 40 µL, (H2O) 15 µL N
2 -581.7 sec Sample (Sample) 10 µL, (H2O) 15 µL Y
3 -540.6 sec R2ARM R2 (T3-Chemibead) 20 µL, (H2O) 15 µL N
4 -123.1 sec R2ARM R3 (Sensibead) 60 µL, (H2O) 75 µL N
5 0 sec LOCI ARM LOCI read vessel (4 reads)
Method Specifics 0
• LOCI® method, a homogeneous, sequential (competitive) chemiluminescent assay.

• FT4L method is only availale on Dimension® EXL™ system with LOCI® Module.
• Flex® type = 8 well. All FT4L reagents are liquid, and originally were not mixed by the
instrument.
• In software version 9.1 or higher a design change wa made to improve uniform reagent
delivery. Chemibead and Sensibead reagent wells are mixed by the instrument when
the well is first unctured. Mixing is performed by the R2 or R3 probe (RMS). Mixing is
accomplished by aspirating 30 µL of reagent from the well and then dispensing it back
into the same well for a total of 25 times (referred to internally as “thumper mixing”). This
process is performed automatically when a new Chemibead or Sensibead well is punc-
tured.
FT4L Flex® Configuration (8 well Flex®)

1, 2 Streptavidin Sensibeads Liquid
3, 4 T3 Chemibeads Liquid
5, 6 FT4 Biotinylated-Ab Liquid
7, 8 Empty Liquid

F Methods 183
• Coefficients:
- C0 = 5328.0
- C1 = -5331.0
- C2 = -1.8
- C3 = 0.7
- C4 = 0.5
• FT4L method uses the LOCI® THYR Cal (RC610A) for calibration. Level 1 is not
included in the LOCI® THYR Cal carton. Reagent grade water must be used as the
level 1 calibrator for the FT4L method. During calibration each calibrator level is ana-
lyzed for three replicates. The FT4L method is a logit method, and the calculated slope
(m) should be between 0.95 and 1.05. The intercept (b) should be 0.0 or clinically insig-
nificant. The correlation coefficient (r) should be between 0.990 and 1.000.
• The assay range for the Dimension EXL FT4 method is from 0.1 to 8.0 ng/dL. The FT4
method reports to 1 decimal places. Samples with results in excess of 8.0 ng/dL should
be reported as “/greater than 8.0 ng/dL”. Samples should not be diluted. Samples with
results less than 0.1 ng/dL should be reported as “less than 0.1 ng/dL”.
Troubleshooting 0
troubleshooting should start with checking R2 alignments/ fluidics, followed by sampler
alignments/ fluidics.
• XLink instructions can be found in the EXL™ with LM Service Guide. Chemdata file will
contain summarized FT4L QC data. LOCIDATA file contains LOCI® reads and module
level checks. Standard Dimension® filterdata holds no FT4L or LOCI® method informa-
tion. LOCIDATA can be obtained via the snapshot directory. Software versions 9.0SP3
and higher will have the “get LOCIDATA” command, which will pull most recent LOCI-
DATA (similar to “get filterdata” command).
Kcount 20% below the mean recovery of the level 6 calibrator. Frequent occurrence of
this error indicates either the wrong calibrator level run, or a reagent delivery issue with
the Chemibead or Biotinylated Antibody. If the error is specific to a single sample, the
sample should be diluted 1:2 with a sample that has a known concentration. If the sam-
ple does not recover appropriately, an interferrent should be suspected.
• Measurement Errors are generated when the low signal value (20% below the mean
recovery of level 6 calibrator) used to trigger the abnormal reaction error is missing.
This can occur if the calibration is processed but not accepted.
• The LOCI® Read routine is composed of 3 distinct reads which occur in this order: 1)
Pre-read, 2) Assay read, and 3) Gain read. The Pre-read and Gain reads produce diag-
nostic information to identify a malfunctioning LOCI® detector, shutter, or light emitting
diode (LED). Both occur on an empty read chamber with no vessel present. For FT4L,
the Assay Read is composed of four assay read cycles. For each assay read cycle, the
reaction vessel is illuminated for 700 msec, and after a 100 msec gate delay, the chemi-

184 F Methods
luminescent signal is collected for 500 msec. Total signal, reported in kilo-counts
(Kcounts- found in the LOCIDATA file under the Primary Column with LEGEND: FT4L
signal. This is the sum of the 4 assay read cycles in counts/1000). These 4 assay read
cycles (referred to as ASY CPM rd 1-4 in the LOCIDATA file), produce consistent pat-
tern counts at reportable FT4L concentrations. The pattern of the 4 reads may be valu-
able as misdelivery of reagent may show an abnormal pattern. The graph below shows
the pattern of the 4 assay reads when each reagent is individually missing from the
reaction vessel.
Fig. 2: FT4L Cycle Patterns
Results Monitoring
• The FT4L method uses the readVF as a result monitor, this is found in the LOCIDATA
file in the column ASY TOT VF. ASY TOT VF is the sum of the four ASY VF Rd. The
settled.
is required to reliably detect this type of error. The first 30 results with a new Flex® lot or
calibration are averaged and the 31st result is the first to be checked with the results
monitor. It passes if it is within +/- 20% of this average and is then included in the aver-
age. After a total of 250 tests, the running average over the lst 250 passing results is
used.
ing legends: tVFR mean, tVFR sd, lo limit, and high limit.

F Methods 185
• Abnormal Assay Troubleshooting for FT4L should include checking R2 alignments, fol-
lowed by R2 fluidics.
Contamination Read
• The contamination read occurs after the illumination LED’s have been fired during the
software versions 9.0SP3 and higher, the read can be found in the LOCIDATA file
under column Contamination (In prior software versions the Contamination column will
always read “0” - The Contamination Read can be calculated by multiplying the PRE
Tot CPM column by 3.3333). The contamination value is typically below 45 counts. If a
contamination read exceeds acceptable limits it will produce Error 849- Failed Reader
Contamination Check, and the test will not process.
should be performed following replacement. Prior to replacing the vacuum cup, insert
and retainer seal, the HM incubation wheel should be examined to ensure there is no
done in the R2 delivery area. Should htere be any stray fluids, cleanup should be per-
Illumination Read
• The illumination read is a measurement taken with the illumination photodiode of the
illumination LED banks function at the beginning of the pre-read. Acceptable range of
the illumination read is between 150,000 and 500,000 counts. In software version
9.0SP3 and higher the Illumination Read should appear in the column Illumination in
the LOCIDATA file. (In prior software versions the Illumination column will always read
“0”).
• The Illumination Read can be calculated by multiplying the PRE Tot VF column by 2.
The Illumination value must be within 2.5% and 7 standard deviations from the mean. If
the value is greater than 7 standard deviations it must be within 1% of the mean. If the
illumination read exceeds acceptable limits it will produce Error 550- Failed Reader Illu-
mination Check.
• Over illumination failures may be caused by:
- Noise related to electrical components, inspected to ensure cable routing is correct. If
- Combination of instrument LOCI® reader sensitivity and reagent lot activity. If errors
started with new lot of reagent contact CCC/RSC. Do not replace parts.
- Patient samples have not caused over illumination errors because FT4 is a reverse
curve. It is very rare to have a patient sample with a near zero FT4 value.

186 F Methods
Gain Read
values output into the LOCIDATA file. These are GAIN Tot CPM, GAIN Tot VF (the sig-
nal as measured by the gain photodiode) and the ratio of the two or Relative Gain.
Acceptable Relative Gain ratios are between 1.0 and 8.5. Values must also be within
1.0% in the course of a month. If a customer complains of a QC trend over time or com-
plains of not meeting the claimed calibration interval, the Relative Gain ratio should be
checked. Take the mean of the Relative Gain ratio reads fro Day 1 and compare with
the mean of Relative Gain ratios from day 30.
the CPM may have truly fallen out of its usable life, and have a Relative Gain ration of
below 1.0 (this, however, should not happen for years of use). Persistent gain read
Ambient Temperature
During development, the FT4L method showed susceptibility to ambient temperature
shifts. Design changes were made to address theis including redesign of the HM ring ther-
mal control and methpar changes. The worst case situation is calibrating FT4L at 18°C
(64°F) and recovering samples at 30°C (86°F), shifts in FT4L recovery of ~10% can be
observed (18°C and 30°C are the instrument operating extremes). QC material is impacted
more than patient samples or calibrators.

result in signal lower than the Level-6 Calibrator. An “Assay Range” error should appear
when Bio-Ab reagent is not delivered. Partially missing Bio-Ab isnot easily identifiable.
The amount of signal loss depends on the fraction that is missing.
background. Signal will be extremely low; below 1 Kilo-count. An “Above Assay Range”
error should appear when Chemibead reagent is not delivered. Partially missing
• Non-delivery of sensibead reagent is flagged by Abnormal Assay message- see results
monitoring section above.
• Completely missing sample results in a FT4 value close to 0 ng/dL. A “Below Assay
Range” error should occur. Paritally missing sample is not easily identifiable.

F Methods 187
Level 2 - Calibrator Substituted for Water

TSHL and FT4L both use LOCI® Thyroid Calibrator (RC610) and FT3, TSHL and FT4L use
LOCI® Thyroid Calibrator (RC610A). Given that the FT3 and TSHL methods use Level-2
as its zero-level calibrator, a customer could inadvertently substitute Level-2 instead of
water during a FT4L calibration. Water and Level-2 calibrator produce very similar signal,
and a calibration curve using Level-2 yields excellent curve fit and acceptable serum/ QC
recovery above 0.6 ng/dL. Low-end results would be slightly inflated.

188 G Methods
8-
GENT
8G Methods
Method Chemistry 0
First Cuvette (Probe Wash)
Event # Event Delivery Volumes/ Measurement Mix

1 R1ARM (R4) 71µL, (H2O) 260 µL N
2 SAMPLE 0, (H2O) 24 µL Y

5 R2ARM (R1) 64 µL, (H2O) 49 µL Y
Method Specifics 0
• Pseudo-rate, bichromatic 340/ 700 nm.

• Flex® type = 8 wells, all liquid reagents.
• As with all PETINIA methods, GENT is a nonlinear method with five C terms. All terms
will change with calibration except the C4; C4 is 0.5.
• Acceptable specimens: serum and plasma (heparin, citrate, EDTA).

G Methods 189
since this may alter Particle Reagent and can cause gross imprecision.
• GENT has a 0.5% NAOH wash to eliminate carryover (first cuvette, probe wash).
Troubleshooting 0
Error Messages
Abnormal Reaction (Check 700 > 100 mAU)

Root Cause:
• Weak source lamp.
• Dirty or improperly aligned photometer lenses.
• Photodiode: Perform inner/outer check. If not within 80 mAU, replace photodiode.

error, analyze sample by an alternate method since it is pos-
sible there is an interfering substance present in the sample.
Abnormal Reaction (nonsp > 50 mAU)

check for non-specific aggregation prior to the addition of the antibody reagent.
Root Cause:
• Sample quality issues such as fibrin strands, clots.
Absorbance (monoPR > 1500 mAU)

Root Cause:
• Particles aggregated on their own in Flex well.
Absorbance (Part 1 < 350 mAU)


190 G Methods
Root Cause:
• R1 probe tubing crimped.
Below Assay Range

GENT concentration below assay range.
• If the calculated sample concentration confirms the concentration to be < 0.20 µg/dL,
the result should be reported as “less than 0.20 µg/dL”.
Above Assay Range

GENT concentration above assay range.
• Dilute sample with GENT-free serum or DDRUGCII level 1, enter dilution factor.
Assay Range Diluted

The sample was autodiluted but the result still exceeded the assay range. Dilute sample
with GENT-free serum or DDRUGCII level 1, enter dilution factor.
Root Cause:
• Photometric issues such as weak source lamp, dirty cuvette windows.
• Flex reagent exposed to freezing conditions.
Within-Lot Accuracy
Root Cause:

G Methods 191

192 G Methods
GGT 8.1
Method Chemistry 0
First Cuvette (Probe Wash)

1 R1ARM (R1) 75 µL, (H2O) 255 µL N
Method Specifics 0

• 405 nm filter critical.
• Methodology: GCNA.
Troubleshooting 0
• Correlation from one instrument to another affected by photometer system - source

lamp/ filter change.
• GGT is present primarily in the liver, kidney, pancreas and prostate.
• Check the coefficients:
- C0 = -1.000, C1 = 3.360 (standard volume)
- C0 = -8.000, C1 = 7.230 (reduced volume)

G Methods 193
Tab. 52 Limit Table

A 405/600 80 250 3.5 0.5 abnl Active
assay

GGT A on sample and reagents Check GCNA delivery by R1ARM
Back extrapolated, air blanked Check wells 1-6 for tablet hydration
Bichromatic (405/600)

194 G Methods
GLUC 8.2
Method Chemistry 0

1 R1ARM (R1) 56 µL, (H2O) 251 µL Y
Method Specifics 0
• Endpoint, bichromatic 340/ 383nm.

• Liquid reagents, no hydration needed.
• Sample initiated method.
• Urines do not need a preservative. Qualified autodilution volume for urine is 2 µL.
Troubleshooting 0
Precision
• Sample drain dirty or clogged.
• Sample tubing crimped or leaking.
• Poor photometric system.
• Extremely low dissolved oxygen content in water.

G Methods 195
Result Monitor
Tab. 54 Limit Table

A 293/383 20 250 1.20 0.85 abnl Active
assay
B 340/383 20 250 1.02 0.96 abnl Active
assay

GLUC A on reagents only Check NADH delivery by R1ARM
End-point at (r2), air blanked No effect by sample
(XL/RxL/Xpand/Max)
B If ratio not close to 100, indicates
Ratio of 103 sec to 180 sec (%) sample undermix.
Weak mix factor
Abnormal Assay A and B Errors
Result Monitor A
• Detects reagent delivery to cuvette.
a) Repeat the sample. If the error does not recur, likely cause is a one-time event.
b) Align R1 probe.
c) Replace R1 tubing.
d) Evaluate optics (lamp and windows).
e) Clean or replace R1 drain.
Result Monitor B
• Indicator of sample mix.

196 G Methods
• Poor mix can result in high or low B flags (Software version 7.2 has enhanced methpar
to minimize effects of sample mix).
a) Tighten sample probe.
b) Align sample probe.
c) Replace sample probe.
d) Replace sample ultrasonics components (transducer, pcb, cable).
e) check/ adjust dissolve oxygen content in water (4-7 ppm).
Abnormal Reaction
• 700 check = read 2 at 700 nm - read 1 at 700 nm. If 700 check > 10, generates Abnor-
mal Reaction flag. Occurs after addition of reagent by R1 arm.
a) Check tightness and alignment of R1 probe.
b) Replace R1 probe.
c) Replace R1 tubing.
d) Replace R1 500 µL pump panel tubing.
e) Replace R1 500 µL syringe.
f) Replace R1 valve solenoid.

H Methods 197
9-
HB1C
9H Methods
Method Chemistry 0
First Cuvette: Calibration (Lysing/ Hb Reaction) (HCAL)

1 R1ARM 0 µL R3, 49 µL H2O N
2 SAMPLE 98 µL Sample, 0 µL H2O Y
Second Cuvette: Calibration (HbA1c Reaction) (HCAL)
Event # Event Delivery Volumes and Filters Mix

2 PHOT READ hard read, turbidimetric 405/700 nm
3 R2ARM 19 µL from first cuvette, 35 µL H2O Y
4 PHOT READ hard read, turbidimetric 340/405/700 nm
5 R2ARM 52 µL R2, 34 µL H2O Y
First Cuvette: Sample (Lysing/ Hb Reaction)

1 R1ARM 300 µL R3, 132 µL H2O N
2 SAMPLE 3 µL Sample, 15 µL H2O Y

198 H Methods
Second Cuvette: Sample (HbA1c Reaction)

2 PHOT READ hard read, turbidimetric, 405/700 nm
3 R2ARM 19 µL from first cuvette, 35 µL H2O Y
4 PHOT READ hard read, turbidimetric, 340/405/700 nm
5 R2ARM 52 µL R2, 34 µL H2O Y
Method Specifics 0

• HB1C uses a logit method for HbA1c calibration. All terms will change with calibration,
except the C4; C4 is 0.5.
• HB1C uses a linear method for Hb calibration. An “E” coefficient is used to translate mA
signal to Hb in g/dL [mmol/L].
• Inverse standard curve for HbA1c: the lower the mA, the higher the HbA1c g/dL result.
• All liquid reagents (no hydrations).
• Put up: 20 tests per Flex®.
• Level 1 calibrator for HB1C contains analyte and is now included in the HB1C Kit. Do
not use saline as with HA1C.
• HbA1c concentration values are printed on the Calibrator IFU Table of Assigned Val-
ues.
• Hemoglobin concentration values for Level 3 and Level 4 are also printed on the Table
of Assigned Values.
• The HB1C calibrator lot is matched to the HB1C Flex® reagent lot in the kit and must
only be used in this combination.
• Accuracy and precision of the pipettes used for hydration of the HB1C calibrator is
extremely important in order to obtain accurate ressults.
• Only whole blood treated with EDTA can be used for this assay. Specimens should be
collected by normal procedures. Whole Blood specimens may be refrigerated at 2-8° C
for up to 7 days or frozen for longer storage.

H Methods 199
• Samples for the HB1C method can only be assayed from a sample cup or Small Sam-
ple Container (SSC). Samples cannot be assayed directly from primary collection
tubes.
• Samples should be mixed gently by inversion or in a rocker mixer prior to pipetting into
the sample cup.
• Before pipetting the sample of whole blood into the sample cup, gently invert the tube
ten times to obtain uniform distribution of the erythrocytes. Avoid the formation of foam.
• Pipette 300-500 µL of the whole blood sample into the sample cup or SSC.
• Sample can sit in the sample cup on the instrument for up to one hour.
• For sample dilutions, mix one part of clinical laboratory reagent water and one part of
well mixed whole blood. Assay the dilution mixture.
NOTE When performing 1:1 dilutions for HB1C, the resulting read-
out (% [mmol/mol] HB1C) is the reportable result. The result
must not be corrected for dilution as it is a calculated result
based on the ratio between HbA1c and Hb. Therefore, a dilu-
tion factor must not be used in the HB1C method.
• Carryover pairs:
- IRON, HB1C
- IBCT, HB1C
HB1C Detailed Calculations
Calculation Method Parameters

mA calculation for Hb From cuvette 2 (Polished 2)
Bichromatic 405/700 nm
c2r2 - c2r1*vol. correction - air correction
E factor generation Average Hb mA of L3 and L4 divided by the average of
the Hb bottle values
mA rates calculation for HbA1c From Cuvette 2 (340/ 700 nm):
Long = c2r4 - c2r2* vol. correction - air correction;

(Polished 0)
Short = c2r3 - c2r2* vol. correction - air correction;

(Polished 1)

200 H Methods

Slope, intercept and trip a = Slope (long rates of L1-L3, short rate for L1-L3)
b = Intercept (long rates of L1-L3, short rate for L1-L3)
Trip = average of long rate for L3
Combo mA calculation for cali- For L1 and L2:
bration
Combo mA = a*short + b
Else
Combo mA = long;
A1c Coefficients Logit function (Combo mA, BV’s)
Software Calculation to Analyte

• Software stores polished mAU from cuvette 2:
- Pol (0) and (1) are polished long and short mAU rates for HbA1c, respectively.
- Pol (2) is polished mAU for Hb measured.
Company Confidential
• Combo mAU is used to calculate g/dL for HbA1c from Combo mAU and logit coeffi-
cients.
• Hb mAU divided by stored calibration coefficient (E) = g/dL Hb.
• Instrument %HbA1c (x) is calculated based on the following equation:
Fig. 3: Calculation
Scalers
Scalers are correction factors of the form shown below and are applied to the % HbA1c
result.
• These factors are used to standardize the instrument result (x) to IFCC or country spe-
cific standardization (ex. NGSP) requirements.
• The factor is of the form of a polynomial equation.
• The factor is customer programmable as each reporting unit (% [mmol/mol]) requires
different factors. % [mmol/mol] scalers are second order polynomial (3 values). Japan
may require third order polynomial function (4 values).
- a (x3) + b (x2) + c(x) + d
• (x) is the instrument calculated %HbA1c shown above.

H Methods 201
• a, b, c, d are termed scalers

• Effective with software 7.4.5 MR1 and 10.0.5, default scalers for HB1C have been
removed from the method parameters. For each new reagent lot, the scalers must be
entered in the Calibration Set-up screen from the kit carton label. If the scaler values on
the Calibration Set-up screen remain as “0”, an error message will be generated and
calibration will not proceed until values are entered.
Troubleshooting 0
Assay Range (HB1C % [mmol,mol] will be reported)

Assay Range errors will be printed if:
• Result is HIGH:
- The Hb concentration is > 25g/dL [15.5 mmol/L] or HbA1c concentration is > 2.6 g/dL
[1.6 mmol/L]. The % [mmol/mol] HB1C result will be printed. The sample should be
manually diluted with clinical laboratory reagent water. Mix one part of water and one
part of well mixed whole blood. Re-assay the dilution mixture.
NOTE The resulting readout (% [mmol/L] HB1C) is the reportable

result. The result must not be corrected for dilution as it is a
calculated result based on the ratio between HbA1c and Hb.
Therefore, a dilution factor must not be used in the HB1C
method.
- Autodilution is not available for this method.

• Result is LOW:
The HB concentration is <5.0 g/dL [3.1 mmol/L] or HbA1c concentration is <0.3 g/dL
[0.2 mmol/L]. The % [mmol/mol] HB1C result be printed. The sample should be
repeated using a new aliquot of whole blood. If the message persists, a sample or sam-
pling problem should be investigated. Follow Below Assay Range information below.
Below Assay Range (HB1C % [mmol/mol] will not be reported)

Below Assay Range errors will be printed if:
• HbA1c mAU is > C0.
• The HB result is < 5g/dL [3.1 mmol/L].
• Calculated HbA1c ratio is <3.6% [17 mmol/mol] (software 10.0 and higher).
Dismpense a new 300–500 µL aliquot of whole blood and reassay the sample. If the errors
persist, confirm correct instrument operation by running QC and also evaluate potential for
a Flex® related issue (ensure acceptable QC results were obtained from the same well-set
as the patient sample. Download the filterdata and message log and evaluate the HB and
Hb1Ac analyte values (g/dL [mmol/L]). If HB and Hb1Ac are both low, consider either sam-
ple or sampling issue (especially if QC above is acceptable). Consult with lab whether the

202 H Methods
patient sample can be analyzed for HB by alternate method (CBC analyzer). If HB is not
confirmed, consider sample delivery issue. The vast majority of patient samples would not
be expected to fall below the component assay ranges, especially the HB limit. If HbA1c
<0.3 g/dL [mmol/L] but is not low, consider possible reagent mis-delivery (Polyhapten). If
unresolved, the recommendation is for the specimen to be analyzed by an alternate
method with wider reportable ranges. Rarely, some QC materials may trigger the HbA1c
component limit as the material has low concentrations of both component analytes. After
confirmation of proper instrument operation, suggest an alternate QC material with higher
HbA1c (g/dL) concentration.
Above Assay Range

Above Assay Range errors will be printed if:
• Absorbance rates for HbA1c are < C0+C1.
• HB result is > 25 g/dL [15.5 mmol/L].
• Calculated HbA1c ratio is > 16.0% [151 mmol/mol] (software 10.0 and higher).
The sample may be diluted with clinical laboratory reagent water. Mix one part of water and
one part of well mixed whole blood. Reassay the dilution mixture.
NOTE The resulting readout (% [mmol/mol] HB1C) is the reportable

result. The result must not be corrected for dilution as it is a
calculated result based on the ratio between HbA1c and Hb.
Therefore, a dilution factor must not be used in the HB1C
method.
If the ABOVE ASSAY RANGE message persists on the diluted sample, the likely cause is
a calculated ratio >16.0% [151 mmol/mol]. In this situation, dilution is unlikely to resolve the
flag since both components will be altered similarly, with no resulting change to the ratio.
Confirm correct instrument operation by running QC and also evaluate potential for a Flex®
related issue by ensuring that the patient sample is run on the same wellset as acceptable
QC. To demonstrate that the sample is >16.0%, you can suggest that sample be mixed 1:1
with a known QC (normal QC) and the mixture analyzed. Follow the calculation instructions
in the “Mixture of a Sample and Known Standard” section of the Dimension® Operator’s
Guide Appendix. If sample is confirmed >16.0% [151 mmol/mol], suggest that sample be
analyzed by an alternate method or handled according to laboratory procedure.
• Autodilution is not available for HB1C.
LO/HI Errors
• The HB1C result may be accompanied by “LO” on the report slip when the %
[mmol/mol] HB1C result is below the reference interval under CSF/BLOOD.
• The HB1C result may be accompanied by “HI” on the report slip when the final %
[mmol/mol] HB1C result is above the reference interval under CSF/BLOOD.

H Methods 203
Arithmetic Errors
Arithmetic Errors will be printed if:
• The hemoglobin (HB) extinction coefficient (E) is 0 or not assigned. Results will not be
printed. Recalibrate and rerun the sample.
• The mau for hemoglobin (HB) is ≤ 0. Results will not be printed. Recalibrate and rerun
the sample.
• The four scalers in the method calibration screen are set to 0. No results will be printed.
Enter the correct scalers provided in the HB1C Kit carton label.
Abnormal Reaction
Two flags (one for cuvette 1 and one for cuvette 2) are defined in the HB1C Method Param-
eters for sample testing to warn customers of insufficient volume in cuvette. The numeric
limits were set by analyzing measured mA from cuvettes with insufficient reagent/ sample
volumes. The absorbance at 700 nm when enough reagents are present was lower than
that for empty cuvettes. However, when the volume is so low that the light beam is passing
through the meniscus, the reads at 700 nm will be higher than that for the empty cuvettes.
Therefore, the following equations are employed for flagging insufficient volume in cuvette.
c1lovol = (c1r1[700] - c1r0[700])
c2lovol = (c2r1[700] - c2r0[700])
Limits
• If (c1lovol > 50.0)
FOAM_ERROR (Abnormal Reaction)
• If (c2lovol > 50.0)
The same flag is used in the HB1C Method Parameters for Calibration (HCAL) for cuvette 2
only. The calculation for the c2lovol flag is:
• If (c2lovol > 50.0)
The use of c1lovol flag for cuvette 1 is inadequate in the HB1C Method Parameters for Cal-
ibration (HCAL) because there is normally insufficient volume in the first cuvette.
In the sample testing method parameters, c1lovol may detect insufficient volume in the 1st
cuvette. Because mixing the hemolyzing reagent may result in foamed meniscus,
FOAM_ERROR (Abnormal Reaction) is used for c1lovol.
When tripped, FOAM_ERROR will give an “Abnormal Reaction” error message that should
prompt the laboratory to align probes and rerun the test.
The c2lovol flag detects insufficient antibody delivery. The read after antibody delivery
(c2r1) is used for this flag. Again, FOAM_ERROR was assigned for the flag. When tripped,
FOAM_ERROR will give an “Abnormal Reaction” error message that should prompt the
laboratory to align probes and rerun the test.

204 H Methods
Result Monitor
Tab. 56 Limit Table
Result Optical Fil- Mini- Maxi- Above Mean Below Mean Error Status
Moni- ters mum mum Factor Factor Message
tor Reps Reps
A 340/700 20 250 1.50 0.85 abnl assay active
B Hb mAu 30 250 1.15 0.80 abnl assay active
ratio

HB1C A = rg 1 Blank = QC cuvette tag (sec- “Abnormal Assay A” errors may be
ond cuvette) caused by dirty cuvettes, optical filters,
Reagent QC-1 calculation: (c2r0), air or a weak source lamp. Verify cleanli-
blank check, Bichromatic (340 ness and proper operation of the photo-
nm-700nm) metric system.
rg 1 Blank = (c2r0[340] - c2r0[700]) +

100.0 (second cuvette)
B = rg2Blank If “Abnormal Assay B” errors are
Reagent QC-2 calculation: Hb mAu encountered, verify that 300-500 µL of
ratio whole blood was used (do not use
serum or plasma) in the sample cup
Rg2Blank = 100.0 ∗ and verify probe alignment and condi-
(χ1µαυ1−χ1µαυ0)/(χ2µαυ5−χ2µαυ1−Η tion.
βΑιρχρρ)(φιρστ χυϖεττε) / (σεχονδε
χυϖεττε)
[577/700] [405/700]
Result Monitor “Abnormal Assay” Error Flags

• Result Monitor A
Result Monitor A is used for monitoring the difference in cleanliness of cuvettes/win-
dows. Normally, the absorbance difference between 340nm and 700nm should be fairly
consistent across all empty cuvette/ windows. If one cuvette/ window shows a large dif-
ference at 340nm/700nm, it is either extremely clean or dirty, either case may affect
reproducibility of the method.The default limits were set in percentage at 1.5 and 0.85,
which are very wide to avoid unnecessary flagging. The A monitor is activated after the

H Methods 205
initial 20 tests are processed for a given Flex® lot. “Abnormal Assay” “A” errors may be
caused by dirty cuvettes, optical filters, or a weak source lamp. Verify cleanliness and
proper operation of the photometric system.
• Result Monitor B
Result Monitor B is for monitoring the cuvette-to-cuvette transfer of the hemolysed sam-
ple. To restrict the transfer variation from one test to the next, the HB1C method moni-
tors the Hemoglobin (Hb) absorbance ratios of cuvette 1 over cuvette 2. An outlier from
the range usually means an insufficient transfer, which consequently results in lower
analyte values. The default limits for this flag are set at 115% and 80%. Result Monitor
B may also be triggered if plasma instead of whole blood is accidentally analyzed. For
each HB1C Flex® lot, the result monitor limits are initially set around the mean derived
from the first 30 test results. When the absorbance reading is outside the limits set in
the Result Monitor function, an “Abnormal Assay B” error message will appear. If
“Abnormal Assay B” errors are encountered, verify that 300-500 µL of whole blood was
used (do not use serum or plasma) in the sample cup and verify probe alignment and
condition.
Although the %HbA1c is corrected to some extent by simultaneous measurements of

both HbA1c and total Hb in the second cuvette, the method may still generate impre-
cise results if the transfer is grossly imprecise since hemolyzing reagent suppresses
the HbA1c mAU signal possibly by inhibiting the formation of Ab-polyhapten com-
plexes. The more hemolyzing reagent is transferred with the sample, the lower the
mAU signal, which subsequently results in higher HbA1c analyte values or vice versa.
An outlier from the range usually means an insufficient transfer, which consequently
results in lower analyte values. The default limits for this flag are currently set at 115%
and 80%. The wide default range is to avoid tripping the flag too frequently for instru-
ments with probes that have borderline precision. This feature also provides an extra
protection against running the wrong type of samples (plasma vs. blood).
For each new Flex® lot, limits are initially set around the mean derived from the first 30
results and then updated based on the rolling mean from the last 250 results. When the
absorbance reading is outside the limits set in the Result Monitoring function, an
“Abnormal Assay” error message will appear prompting the laboratory to rerun the sam-
ple.

206 H Methods
HCG/ LHCG 9.1
Method Chemistry 0
HM Vessel processing

3 Incubation Incubtion 211 sec, Suck vessel dry
5 R2ARM (H2O) 50 µL Y
First Cuvette

2 PHOT READ 577/700
4 PHOT READ 577/700
5 PHOT READ 577/700
6 PHOT READ Hardread 577/700

H Methods 207
Method Specifics 0
• HCG Reagents
- Well 1, 2: conjugate reagent
- Well 3: 1 tablet, chrome, hydrated with 1950 µL of chrome diluent in well 8
- Well 4, 5, 6: 1 tablet, CPRG hydrated with 1500 µL of diluent in well 7
- Well 7: CPRG Diluent
- Well 8: CRO2 Diluent
• IMT probe is cleaned by IMT probe cleaner.
• HCG on Dimension® Xpand®: HCG sample is level sensed by photometric sampler
probe. This probe is washed using probe cleaner bleach present in the sample drain.
• HM method uses reaction vessel and one cuvette.
• Two step immunoassay based on sandwich principle (beta-galactosidase label). Two
step eliminates hook effect and nonspecific binding (3 washes).
Sequential Format, CPRG Detection

• After conjugate addition two one-second mixes occur to break up chrome mass (fine
suspension critical).
• HM RxL method bichromatic 577 nm, 700 nm.
• Calibration type: logit, extended read, trip factor needed. Do not fake calibrations or
copy coefficients. A full calibration is required.
• Calibration slope range: 0.95-1.05.
• Result Monitor: not available in the software for this method, none programmed.
• No hook effect to 1,000,000 mIU/mL.
• Assay range is 0-1000 mIU/mL. An error occurs if “FOD” limit is > 2000 mA and/or 1000
mIU/mL analyte.
- The “assay range” message will point to the need for autodilute. Sample size is 40
µL.
- Set autodilute to 2 µL.
- Only autodilute volume of 2 µL has been qualified for HCG.
- The autodilute capability allows for a 1:200 dilution to occur. Covers assay range up
to 200,000 mIU/mL.
• If FOD limit is > 2000 mA and/or 1000mIU/mL analyte, the instrument will attempt auto-
matically to reprocess for a dilution.

208 H Methods
• Two reaction vessels are loaded onto the HM wheel.

- The sample probe re-enters sample cup to make a 1:10 dilution in the first reaction
vessel (30 µL sample + 270 µL water).
- Chrome is added to the second reaction vessel.
- Sample probe transfers 2 µL (autodilute volume) from first reaction vessel (1:10) to
the second reaction vessel. An autodilute of 1:20 of the 1:10 dilution occurs for a final
1:200 dilution.
- The photometric reaction goes to completion and a final printout of the 1:200 dilution
will be printed.
- The message “diluted” appears on the printout for any sample that has been autodi-
luted. The result should be above the assay range of the method. (For HCG, > 1000
mIU/mL).
- Do not remove sample or segment from wheel until after final printout is complete
and no dilution messages are present.
• For HCG, if conditions for autodilute are not met, HIGH “A” errors will be generated.
• Samples greater than 200,000 mIU/mL will have assay/dilute message. These sam-
ples require a greater than 1/200 dilution by the operator.
• Conditions for autodilute:
- Autodilute and Autorerun must be turned on. Check in System Configuration.
- The sample is not manually diluted and no dilution factor entered. (Dilution factor
entered negates Autodilute).
- Method must have autodilute volume entered for specific fluid type.
- System must not be in error state (mechanical or silent error).
- Test has not been diluted already (once per test). The system allows one sample to
be accessed only two times - once when the sample is run as a whole and once when
the sample is diluted.
- Test was not aborted (stopped by the user).
- For tubes, must have sufficient volume left for Autodilute. No level sense.
- Must have HYDRATED calibrated reagent of the same lot available on board.
Autodilute for HCG

Recommended autodilution volume: 2 µL.
HCG uses an autodilute sequence that is different than any other method. In a normal
method with a sample size of 40 µL, a 2 µL autodilute would be equivalent to a 1:20 dilution.
However, in HCG we have added an additional 10 fold dilution prior to taking theautodilute
sample. This was done to cover as large a range as possible. This prior additional 10 fold
dilution allows diluted results on samples as high as 200,000 mIU/mL. So, in HCG a 2 µL
autodilute sample is equivalent to a 1:200 dilution (10 x 20 = 200). The instrument auto-
matically does the calculations.

H Methods 209
How is this additional 10 fold dilution done?

• When an HCG result is outside the assay range (0-1000 mIU/mL) and the autodilute
feature is programmed by the operator, 2 reaction vessels will be loaded onto the incu-
bate wheel. The photometric sample arm will pick up sample and add it to the first ves-
sel with water to make the 10 fold dilution (the same way it does for the AUD methods).
Then, after chrome is added to the second vessel, the sample arm will pick up the 2 µL
(programmed by operator for autodilute) from the first vessel and deliver to the second
vessel. Then the conjugate is delivered to the second vessel and it gets incubated to
form sandwich.
- FOD error will enable auto-dilute
Troubleshooting 0
• Abnormal reaction reagent blank flag:

This flag is used to assess the activity of the CPRG reagent using a reagent blank upper
and lower limit check. The error occurs if the blank mau exceeds the limits.
Lower limit = 50mAU; Upper limit = 500mAU
The lower limit flag results when there is a problem with the CPRG hydration. Probable
cause may be a poor hydration of the well (suspect change reagent probes). The hydra-
tion occurs using the R2 probe. The R1 probe delivers the CPRG reagent to the
cuvette.
• Abnormal reaction chrome flag error occurs if an assessment of the chrome in the
cuvette fails at either the upper or lower limit set in the software. The limits are as fol-
lows:
Lower limit = 51mAU; Upper limit = 226mAU
- If low, may indicate low chrome delivery to the cuvette. Proper tablet dissolution and
good mix of chrome is critical. Avoid resettling of chrome in well with good mix and
remix (ultrasonics R2 delivery). If a failure occurs change R2 probe as it may be
worn, clogged or misaligned. Check for chrome loss at the wash station and wash
probe alignments. Clean wash probes by flushing with warm water. Change/ install
new wash probes. Check proper functioning of mixers and sample probe to vessel
alignment for chrome resuspension in vessel.
- Ultrasonics problems such as worn transducers or improper ultrasonics settings may
cause mix problems that may produce a weak mix and a poor dissolution of the
chrome tablet. Change probes and/or transducers, check ultrasonics settings. Look
for residuals of any poorly dissolved tablets physically in reagent well.
- Review of Xlink filterdata must be checked to determine the high/low failure mode for
the reagent blank and the “cro2”.
- Check for sample integrity: fibrin, clots, or particles. Refer to CSB D0244 Specimen
Preparation and Handling for Dimension® Heterogeneous Module.

210 H Methods
Result Monitor
Tab. 58 Limit Table

A 700 15 250 0.0 0.0 abnl Not
assay active

HCG air-blanked, mono-chromatic 700 nm cro2 check

H Methods 211
HIL 9.2
Method Chemistry 0

1 R1ARM (R1) 0 µL + (H2O) 300 µL Y
2 PHOT READ 293/405/452/700 nm
3 SAMPLE 20 µL + (H2O) 30 µL Y
4 PHOT READ 293/405/452/700 nm
5 PHOT READ 293/405/452/700 nm
Method Specifics 0
• HIL - tests sample for hemolysis, icterus, lipemia.

• Endpoint, polychromatic 293/405/452/700 nm.
• Key = {*Alt P5*}.
• No Flex® reagent cartridge required.
Troubleshooting 0
Accuracy Issues
HIL Abnormal Assay Error (rgqc lo) - obtain filterdata
1. Insuficient or no sample - confirm sufficient volume in sample cup.
2. Fibrin in sample cup - replace sample with fibrin-free sample.
3. Offline dilution of serum/ plasma sample - HIL must use undiluted serum or plasma
only.
4. Incorrect sample type - HIL must use serum or plasma only.
5. Sample probe worn - replace sample probe.
6. Sample probe loose or misaligned - tighten sample probe and perform sample probe
alignments.
7. Sample probe tubing crimped or leaking - replace sample tubing.

212 H Methods
HIL Abnormal Assay Error (rgqc hi) - obtain filterdata

1. Reagent probe worn - replace probe.
2. Reagent probe loose or misaligned - tighten probe and perform probe alignments.
3. Reagent probe tubing crimped or leaking - replace tubing.
4. Insufficient water delivery - troubleshoot R1 pump panel/ fluidics.
5. Grossly lipemic sample - ultracentrifuge or clarigy sample and rerun.
HIL Abnormal Reaction Error
• Precipitation of atypical protein in sample (e.g. myeloma) - no known solution; HIL not
reliable for this sample type.
H Index Value Obtained on Non-Hemolyzed Sample
• Highly turbid sample - ultracentrifuge and rerun. DO NOT dilute for an error.
I Index Value Obtained on Non-Hemolyzed Sample
L Index Value Obtained on Non-Hemolyzed Sample
Apparent discrepancy between visual estimation of lipemia and/or measured TGL
result and reported L index value.
• Heterogeneity of endogenous lipid species prevents measured TGL levels in the sam-
ple from correlating with either visual estimations of lipemia or HIL index values. (i.e.,
depending on the particle size, the lipids in the sample may or may not result in a visual
lipemia or an increase in absorbance of 700 nm) - provide customer with technical
explanation for apparent discrepancy.
Result Monitor
Tab. 60 Limit Table

A 293/700 10 250 2.5 0.60 abnl Active
assay

HIL A = rg2Blank Checks for sample addition.
Reagent QC calculcation: end-point
(r4), water blanked (r2), bichromatic
(293/700)
Limits: Mean -40%, +150%

I Methods 213
10-
IBCT
10I Methods
Method Chemistry 0

3 SAMPLE 600/700 nm
4 PHOT READ (R3) 25 µL, (H2O) 25 µL Y
6 R2ARM (R4) 75 µL, (H2O) 25 µL Y
Method Specifics 0

• Flex® type = 8 wells.
• No pretreatment protocol.
• Calibration type: linear.
• QC products preserved with preservative chloroacetamide may give inaccurate IBCT
results.
Troubleshooting 0
• QC material with bovine, avian or other animal transferrin source will give low results
and can cause imprecision.
• Falsely elevated IBCT values may be caused due to reagent carryover with ACTM, CA
and TP methods. This problem is resolved by selecting “Optimized Time to Results”.
• Iron supplements such as Fe-dextran and Ferrous sulfate may cause falsely elevated
IBCT values. If the IBCT value is >900 µL/dL, it is possible that the patient is on iron
supplement therapy and patient history should be examined for this. Refer to the
method insert sheet for more information.
• Plasma samples are not approved for use on this method. Discordant, unflagged,
results can be obtained if customer processes plasma.

214 I Methods
• Evaluate the following as potential causes of imprecision.

- High Outliers. Check condition of R1 probe and alignments.
- Low Outliers. Check condition of R2 probe and alignments.
- Ultrasonics. If no problems are uncovered with reagent probes, evaluate ultrasonics
(e.g., loose probe tips, probe assembly, transducer, and PC board).
- Method is sensitive to photometric position. Check READ 1, evaluate PXQC results.
• Carryover pairs: ACTM, IBCT; CA, IBCT; TP, IBCT

I Methods 215
IGA 10.1
Method Chemistry 0
First Cuvette (pretreatment/dilution)

1 R1ARM (R1) 135 µL, (H2O) 170 µL Y

1 R1ARM (R1) 110 µL, (H2O) 190 µL Y
2 R2ARM (From cuvette #1) 4 µL, (H2O) 46 µL Y
4 R2ARM (R2) 50 µL, (H2O) 20 µL Y
7 PHOT READ Hardread 340/700 nm
Method Specifics 0
• Endpoint, bichromatic 340/700 nm (turbidimetric method).

• Autodilute volume is 2 µL.

216 I Methods
• Calibration volume is 60 µL.

• Two cuvette method: Cuvette 1 is for sample predilution, Cuvette 2 is reaction cuvette.
Troubleshooting 0

Checks for foaming and turbidity, check 700 (r1 [700] - r0c2 [700] > 5 mAU
• Centrifuge cloudy or turbid samples; may need to dilute the sample with saline.
• Frozen samples stored long-term may have gone through freeze/thaw cycles and
aggregate when mixed with buffer containing PEG. This would cause atypically low val-
ues due to falsely elevated sample blank. Collect fresh samples.
lular debris, etc.
• Monoclonal immunoglobulin samples may spontaneously aggregate when mixed with
buffer or diluent. Try testing by alternate methodology.
- If cryoglobulins or cold agglutinins are present, try warming the sample to 37° C
before testing.
• Align sample and reagent probes; misalignment may cause foaming.
if related methods (C3, C4, IGG, IGM, & TRNF) are also affected, check the following:
• Tag readings for empty cuvettes- readings at -72 seconds should be around 200 mA for
all wavelengths.
- Sporadically high reads across all wavelegths may indicate dirty windows.
• Snapshot to check the readings of the photodiode- in cases of abnormal reaction, the
snapshot may read in the 90’s (atypically high- typical readings are 50 to 70).
“Antigen Excess” Errors

• Samples with the Delta Test > Delta Ref will be marked with “antigen excess” error.
• If autodilute is enabled, these samples will be diluted automatically and rerun.
• If the instrument is not configured for autodilute, manually dilute the sample 1:5 with
saline and rerun.

I Methods 217
• Antigen excess detection is based on transfer of sample from cuvette 1 to cuvette 2 in

two stages. The photometer takes a bichromatic read after the first sample transfer step
(r2 read) and subtracts the blank read from it to get a “Delta_Test” value. During calibra-
tion, a similar value is computed from the r2 read of the Level 5 calibrator (Delta_Ref)
and is stored in memory.

- This has a cuvette to cuvette transfer of sample by R2 probe and tubing.
Precision Issues
• Clean windows.
• Worn or misaligned sample or reagent probes (R2 delivers sample from cuvette 1 to
cuvette 2).
• Pinched sample or reagent tubing.
• Run PXQC.
• Photodiode.

218 I Methods
IGG 10.2
Method Chemistry 0

1 R1ARM (R1) 135 µL, (H2O) 170 µL Y

1 R1ARM (R1) 110 µL, (H2O) 190 µL Y
4 R2ARM (R2) 50 µL, (H2O) 20 µL Y
Method Specifics 0


I Methods 219

Troubleshooting 0

Checks for foaming and turbidity, check 700 (r1 [700] - r0c2 [700] > 5 mAU.
lular debris, etc.
before testing.
if related methods (C3, C4, IGA, IGM, & TRNF) are also affected, check the following:
all wavelengths.

saline and rerun.

220 I Methods


Precision Issues
• Clean windows.
cuvette 2).
• Run PXQC.
• Photodiode.

I Methods 221
IGM 10.3
Method Chemistry 0

1 R1ARM (R1) 135 µL, (H2O) 250 µL Y

1 R1ARM (R1) 80 µL, (H2O) 210 µL Y
4 R2ARM (R2) 50 µL, (H2O) 10 µL Y
Method Specifics 0


222 I Methods

Troubleshooting 0

Checks for foaming and turbidity, check 700 (r1 [700] - r0c2 [700] > 5 mAU.
lular debris, etc.
before testing.
if related methods (C3, C4, IGA, IGG & TRNF) are also affected, check the following:
all wavelengths.

saline and rerun.

I Methods 223


Precision Issues
• Clean windows.
cuvette 2).
• Run PXQC.
• Photodiode.

224 I Methods
IRON 10.4
Method Chemistry 0

1 R1ARM (R1) 200 µL, (H2O) 40 µL Y
4 R2ARM (R2) 70 µL, (H2O) 20 µL Y
Method Specifics 0
• Endpoint, Bichromatic 600/700 nm.

• Liquid reagents, no hydration required.
• Calibration type: Linear.
• Level 1 calibrator is not supplied. Customer supplies Clinical Laboratory Reagent
Grade water.
• Standard sample volume is 40 µL, reduced sample volume is 25 µL.
• Autodilute volume at standard sample size is 20 µL. Autodilute is not qualified for using
reduced sample size.
• Calculated Results.
UIBC = IBCT – IRON
%ISAT = [IRON/IBCT] x 100
Troubleshooting 0
• Iron values may be falsely elevated due to:

- Therapeutic iron-containing medications (iron dextran, ferrous sulfate, etc.).
- Hemolysis.
- Lipemia.

I Methods 225
• Water is used as the level 1 calibrator. If the water is contaminated with iron (not using
reagent grade water or if the Millipore system is not working properly), the calibration
will give higher mau.
• Serum iron show diurnal variation with peak values seen in the early morning. Because
of this diurnal variation, serum iron may vary by up to 30% during the course of the day.
• EDTA, sodium citrate, and potassium oxalate will chelate metal iron. IRON samples
should not be collected in these tubes. Similarly, draw order during phlebotomy could
impact results if there is cross-contamination from drawing one of these tubes prior to
the serum or heparin tube for IRON determination. The IRON results in these cases
may be falsely low.
• Lipemic samples may generate an ‘Abnormal Reaction’ test report message.
- Check700 = r 2 [700] – r1 [700].
- If (check700 > 300) FOAM_ERROR, will generate ‘Abnormal Reaction’ flag.
• If the sample is turbid:
a) Clear turbidity from lipemic samples (for example: by ultracentrifugation or what-
ever procedure customer has established in their laboratory for dealing with lipemic
samples).
b) Process via alternate methodology.
• If the sample is not turbid, suspect foaming:
a) Check tightness and alignment of sample probe tip.
b) Replace Sample probe tip.
c) Check tightness and alignment of R2 probe tip.
d) Replace R2 probe tip.

226 L Methods
11-
LA
11L Methods
Method Chemistry 0

3 PHOT READ 340/383 nm -
4 R2ARM (R1) 34 µL, (R2) 20 µL, (R4) 20 µL, (H2O) 50 µL Y
Method Specifics 0
• Linear rate, bichromatic 340/383 nm..

• Whole blood stabilized with sodium fluoride/separated within 15 minutes is the most
suitable specimen.
• Heparinized samples need to be iced immediately.
• Susceptible to reagent ultrasonics.
• Long PHOT READ time (r3=658.9 sec.) . Instrument throughput will be reduced when
photometer read time is greater than 454 seconds
• Due to issues with impact to HM performance, the lactic acid method will no longer
“stop the wheel.” The scheduler will delay processing of LA tests if there are HM meth-
ods requested. Processing of LA is most efficient when processed as a STAT test and
when the assay is started while the instrument is in Standby
• R2ARM reagent delivery include three reagent component (triple-dip).

L Methods 227
LDI 11.1
Method Chemistry 0

1 R1ARM (R1) 106 µL, (H2O) 61 µL N
3 R2ARM (R2) 50 µL, (H2O) 60 µL Y
Method Specifics 0

• Methodology = NAD, lactate > pyruvate.
• All liquid method.
• Calibrated method – uses Enzyme I Calibrator (ENZ I CAL) DC35.
• Measuring range 6-1000 U/L (0.10-16.70 µκατ/Λ).
• Serum and (Li and/or Na) heparin Plasma. Serum is specimen of choice.
• No hazard labeling.
Troubleshooting 0
• Check theoretical coefficients: C0= 0.000 C1= 1.000..

• Prime all pumps before measuring the cuvette temperature. If any air is in the lines it will
falsely elevate the cuvette reading that you are measuring.
• Air filter on thermal chamber must be clean, otherwise cuvette temperature will be out
of specifications, especially if ambient temperature is >80°F.
• Switching from I to II on thermometer can cause inaccurate temperature readings. After
switching (scales) wait for meter to stabilize before measuring temperature.
• For accuracy problems from lot to lot do a patient crossover study.
• No sample mix will produce lower results.

228 L Methods
• Low intercept - replace 340 nm filter. Low slope replace source lamp and/or 700 filter.
• Serum is the preferred specimen for measuring lactate dehydrogenase.
• Phlebotomies to obtain samples for lactate dehydrogenase activity concentration
should be carefully done to avoid hemolysis. Lactate dehydrogenase in red blood cells
can falsely elevate the LDI results of hemolyzed samples.
• Platelets may contain high activity concentrations of lactate dehydrogenase. Plasma
samples may contain platelets or platelet agregates which have been known to be
responsible for causing duplicate errors, particularly when plasma specimens have
been spun at shorter than recommended centrifugation time.
• Since lactate dehydrogenase is very sensitive to hemolysis, it is also sensitive to stor-
age and transport conditions of samples.. Exposing specimens during transport to
extreme temperatures, random positions, shaking, or delay in centrifugation, can cause
inaccurate results.
• To get two Dimension® systems to match, replace 340 filter and set temperature using
the same thermometer.
• Method sensitive to cuvette temperature. 1.0°C = 10–15% difference.
Loss of Performance or Stability Due to Shipping Temperature

• Above 25 °C for 48 hours plus 30°C for 6 hours.
• Below freezing temperatures 0°C for up to 17 hours.
High Background Samples

• From some medications or disease states.
• May produce inaccurate low results.
• FOD error flag in methpar – “fod test >1500” – produces “Abnormal Reaction” Flag.
QC Shifts and Patient Results High and Imprecision

• Sample delivery issues – check pump, check sample probe and alignment.
• Check reagent R1 probe and alignment.
• Check pump, check R2 probe and alignment.
• Cuvette temperature high.
• Poor ultrasonic mix of sample or NAD (reagent 20) – check R2 probe.
QC Shifts and Patient Results Low and Imprecision

• Sample delivery low, clot – check sample probe and alignment.
• Check pump, check reagent R1 probe and alignment.
• Check reagent R2 probe and alignment.
• Clogged sample drain.
• Clogged reagent drain.

L Methods 229
• Cuvette temperature low.

• Poor ultrasonic mix of sample or NAD (reagent 2) – check R2 probe.
• Thermal chamber not sealed properly (shift in temperature around the cuvette wheel) –
also check air filter.
• Heavy condensation on top of Flex® - water carried into Flex® - reagent dilution.
• “Foam error” occurs if “check 700” > 60.
• Reagent 1 Buffer open well stability 3 days.
- ALT,LDI
- ALTI,LDI
- AST,LDI
- LA,LDI

230 L Methods
LI 11.2
Method Chemistry 0
First Cuvette

1 R1ARM (R2) 100 µL, (R3) 240 µL, 30 µL (H2O) Y
3 SAMPLE 10 µL, 25 µL (H2O) Y
Second Cuvette

1 R1ARM (R2) 100 µL, (R1) 240 µL, 30 µL (H2O) Y
Method Specifics 0

• Two-cuvette method. First cuvette serves as a sample blank; reaction with lithium
occurs in the second cuvette.
• Final photometric read occurs at different times for cuvettes 1 and 2 for throughput rea-
sons. Chemistry is not affected; formation of color in cuvette 2 occurs very quickly and
is stable.
• Flex® type = 6 well (all liquids).

L Methods 231
• Flex® reagents:
Wells 1 and 2 contain a red lithium dye reagent.
Wells 3 and 4 contain a clear, colorless alkaline salt reagent.
Wells 5 and 6 contain a clear, colorless “surrogate dye” or blank reagent.
• The method is sensitive to the R1 mix, especially due to the presence of an organic sol-
vent (DMSO) in each of the reagents. The condition and alignment of the R1 probe may
affect mixing. Inadequate mixing may result in an accuracy shift or imprecision.
NOTE Dimension® Xpand® instruments operating with software

version 6.0 or 6.0.1 use a 50% duty cycle on the R1 mix.
Xpand® software version 6.1 (or higher) and XL/RxL/ARx
software version 5.2 (or higher) use a 30% duty cycle on the
mix. Xpand® instruments operating a 50% duty cycle may be
more sensitive to the condition and alignment of the R1
probe.
• The method is sensitive to sample mix. If FOD demonstrates foaming with either R1 or
sample mix, there will be increased imprecision with the potential for accuracy shifts.
• Calibration type: Nonlinear, logit coefficients, C4 = 0.5; mAU increases with increasing
lithium concentration
• Calibrator bottle values for lithium are assigned (lot-specific).
• Lithium calibrator is designed specifically for use on the Dimension® system. Calibra-
tors may recover low if processed as unknowns on other systems.
• The lithium dye also binds sodium (but to a lesser degree than lithium). Significant
increases or decreases in serum sodium concentration may produce a bias in lithium
results (refer to insert sheet).
• Serum and sodium heparin are the recommended sample types; lithium heparin is NOT
recommended.
Troubleshooting 0
• Above Assay Range - Samples above the assay range (> 5.00 mmol/L) must be manu-
ally diluted with lithium-free serum. Water is not recommended for manual dilution. Use
of the auto-dilute feature is not recommended.
• Below Assay Range - Samples below the assay range (< 0.20 mmol/L) should be con-
firmed by dilution with an equal volume of calibrator or control product of known value. If
the calculated sample concentration confirms the concentration to be < 0.2 mmol/L, the
result should be reported as “less than 0.2 mmol/L” instead of the numerical value. A
“below assay range” message will also appear if no sample is delivered to the cuvette,
or a fibrin clot prevents delivery of sample to the cuvette.

232 L Methods
• Inaccuracy (particularly at low lithium concentrations) - Evaluate the following as poten-

tial causes of inaccuracy:
Calibrator Values - Ensure that the lot-specific calibrator values were used to calibrate;
ensure that the actual concentration (not zero) was not used for level 1.
Sample and Reagent Probes - Check condition of sample and reagent probes and
alignments. Pay particular attention to the R1 probe and alignments. Visually check the
alignment of the R1 probe in the actual cuvette.
Ultrasonics - if no problems are uncovered with sample or reagent probes, evaluate
ultrasonics (e.g., loose probe tip, probe assembly, PC board).
Sodium Content - Significant increases or decreases in sodium content (e.g. sample
diluted with water) will produce a bias.
• Imprecision - Check condition of sample probe, reagent probes, and alignments.
Method is particularly sensitive to the condition and alignment of the R1 probe. Visually
check the alignment of the R1 probe in the actual cuvette. If no problems are uncov-
ered, pursue troubleshooting of ultrasonics.
• Source Lamp Change - Recalibration of lithium should not be required after a source
lamp change. However, if a change in QC was observed after a source lamp change,
recalibration should be performed.
• No sample - No delivery of sample will result in a “below assay range” message.
• No Flex® - “Ghost” Flex® (i.e., no reagents delivered to the cuvette) will result in an
“abnormal assay” message.
Result Monitor
Tab. 62 Limit Table

A 540/700 30 250 1.18 0.82 abnl Active
assay

L Methods 233

LI A Result Monitor = rgBlank = mau1 Monitors Dye/DMSO delivery by
(second cuvette) R1ARM in second cuvette.
Reagent QC calculation: endpoint A typical absorbance is most likely
(c2r2), air blanked, bichromatic due to inaccurate reagent delivery or
(540/700) insufficient R1 mix. Check fluidics,
Limits: Mean +18% or -18% condition of the R1 probe, and align-
ments.
Result Monitor / Abnormal Assay - This function monitors the bichromatic reagent blank
(mau1) in cuvette 2 for accurate delivery of the lithium dye reagent before sample addition.
The abnormal assay message indicates an absorbance outside of the established result
monitor limits. Atypical absorbance is most likely due to inaccurate reagent delivery or
insufficient R1 mix. Check fluidics, condition of the R1 probe, and alignments.

234 L Methods
LIDO 11.3
Method Chemistry 0
First Cuvette

1 R1ARM (R1) 80 µL, (R2) 130 µL, 103 µL (H2O) N
5 R2ARM (R3) 80 µL, 40 µL (H2O) Y
Fig. 4: LIDO Assay Kinetics
Method Specifics 0

• LIDO uses logit method for calibration. All terms change with calibration except C4; C4
is 0.5.

L Methods 235
• 20 tests per Flex reagent cartridge.

• Whole blood treated with EDTA, lithium heparin, can be used for this assay.
• Specimens should be collected as described in the LIDO Instructions For Use (IFU).
Troubleshooting 0
• May be sensitive to photometer positioning. Make sure the thermal chamber insulation
and photometer cables are not interfering with the photometer. Lubricate the photome-
ter bearing.
• Recalibrate if you replace source lamp, optical filter or photodiode.
• Make sure the Flex reagent cartridge has not been frozen in the instrument or the refrig-
erator, since it may alter particle reagent and can cause gross imprecision.
Hi “A” Error (FOD ERROR)

• This flag represents final absorbance at 340 nm for the last read.
• It is used to check for the final absorbance reading.
• This flag ensures that the absorbance values used to calculate analyte units did not
exceed the photometer detection limits (final optical density or FOD) of the analyzer.
• This error occurs if there is non-specific atypical aggregation due to abnormal proteins
or grossly turbid or lipemic samples.
• If (fod > 1700)
FOD_ERROR
Low “A” Error (IOD ERROR) Case 1

• This flag represents final absorbance at 340 nm for the last read.
• It is used to check for the final absorbance reading.
• This flag ensures that the absorbance values used to calculate analyte units did not
exceed the photometer detection limits (final optical density or FOD) of the analyzer.
• This error occurs if there is non-specific atypical aggregation due to abnormal proteins
or grossly turbid or lipemic samples.
• If (fod > 1700)
FOD_ERROR

• It checks to make sure the particles were added.
• It checks that the particles were delivered and not short-sampled. This flag monitors the
identical phenomenon as Result Monitor A.

236 L Methods
• Imprecision of pipetting both buffer and particle reagent. This may be caused by parti-
cle reagent delivery problems by R1 reagent arm or a gross fluidic problem from a clog-
ging probe, crimped reagent tubing, leaking or loose fitting on pump valves, or bad R1
syringe tips.
• If (part1 > 300)
IOD_ERROR
Abnormal Reaction (FOAM ERROR) Case 1

• This flag checks for aggregation when particles and sample are present (no antibody is
yet added at this point).
• It checks to make sure that nothing in the sample causes non-specific (Nonsp) aggre-
gation of the particles.
• No change in values should occur until the antibody is added.
• If there is a change greater than the limits, the result gets flagged for non-specific
aggregation.
• Check for non-specific aggregation prior to addition of the antibody reagent.
• Sample quality issues such as fibrin strands, small fibrin clot added to the cuvette.
• If (nonsp > 50)
FOAM_ERROR

• Limit is 100 mAU. Checks for foaming, non-specific particle aggregation, and excess
turbidity prior to antibody addition. Checks for foaming, air bubbles, turbidity or scatter
in the cuvette.
• Photodiode. Perform inner/outer check. If not within 80 mAU, replace photodiode.
• (check700 > 100)
FOAM_ERROR

Assay Range Errors

• Assay range errors will be printed if the sample concentration is below or above the
assay range.

L Methods 237
• Assay Range (results below assay range)

Below assay range errors will be printed (without the numerical value) if the sample
concentration is below the calculation range.
- Perform a 50% recovery of know standard or QC material to confirm there was no
activity in the sample and that there was no instrument malfunction.
- If the calculated sample concentration confirms the concentration to be <0.5 mg/mL,
the result should be reported as “less than 0.5 mg/mL.”
• Assay Range (results above assay range)
NOTE Autodilute feature is not available for the LIDO method.
Above assay range errors will be printed if the sample concentration is above the calcu-
lation range.
- Dilute sample with equal volumes of drug-free serum or DRUG CAL II Level 1. Multi-
ply by dilution factor of 2.
Within-Run Imprecision
• Photometric issues such a weak source lamp, dirty cuvette windows.
• Flex reagent cartridge exposed to freezing conditions.
Within-Lot Inaccuracy
Calibration drift due to reagent or instrument instability.
• Photometric issues: weak source lamp or photodiode, dirty cuvettes and windows.
• Temperature of reaction in cuvettes and windows.
Results Monitor
NOTE “Abnormal reaction” report message has higher priority over

“abnormal assay.” Only the highest priority message will
appear on the print out even though there may be more mes-
sages affecting the test result.

238 L Methods
Tab. 64 Limits
Rslt Mntr Optical Filters Minimum Reps Maximum Above Mean Below Mean Error Messag
Reps Factor Factor
A 340/700 20 250 1.5 0.5 abnl assay
Tab. 65 Results Monitor Method Specific Troubleshooting

LIDO Reagent QC - 1 calculation: endpoint (r1), air-blanked, Problem was likely caused by impre
bichromatic (340/700 nm) pipetting both buffer and particle rea
Limits: Mean ± 50% ficient volume of either particle or bu
would trigger this flag.
Monitors the particle blank for each test. The particle blank
is the absorbance taken immediately after addition of par- • Replace R1 probe tip, tubing and
ticle, sample and assay buffer (prior to antibody). This • Check for tightness or replace fitti
measurement has also been corrected for by any back- valves.
ground mAU (any absorbance at 700 nm has been sub- • Use alternate Flex cartridge lot
tracted).
Insufficient volume of either particle or buffer in well would
trigger this flag. Gross fluidic problem from a clogged
probe, crimped reagent tubing, leaking or loose fitting on
pump values or had R1 syringe tips.
Particles may have agglutinated in the Flex reagent car-
tridge (e.g. frozen reagent cartridge).
Reagent QC - 2: not used for LIDO.

L Methods 239
LIPL 11.4
Method Chemistry 0
First Cuvette
Tab. 66 Cuvette #1 (Clean R1 and Sample Probes)

1 R1ARM (R3) 200 µL, (H2O) 100 µL N
2 Sample 0 µL, (H2O) 80 µL Y
Second Cuvette
Tab. 67 Cuvette #2 (Test)

Method Specifics 0

• Flex®type = 6 well.
• Two-cuvette method. R1 probe tip and sample probe tip are cleaned in NaOH from
Flex® wells 5 and 6 into first cuvette, not used in test reaction calculations.
• Interfering method: TGL. R1 and sample probes are cleaned with NaOH to protect from
lipase in TGL reagent.
• Linear calibration with a 0 calibrator level.
• LIPL calibrator must be used for calibration.
• Carryover pairs: ALDL,LIPL

240 L Methods
• Reagent delivery is performed by R1 arm. Troubleshoot R1 probe tip, alignment, ultra-

sonics and fluidics.
• Sample initiated reaction. Troubleshoot sample arm probe tip, alignment, ultrasonics
and fluidics.
Troubleshooting 0
Result Monitor
Tab. 68 Limit Table

A 452/700 60 250 1.5 0.5 abnl Active
assay

LIPL A: Rgt Blank, Air blanked, bi-chro- R1ARM addition, After additionof
matic colipase and substrate in the second
(r1 [452] – r1 [00] –c2r0 [452] – (c2r0 cuvette. This read is taken before
[700]) sample addition. Sudden shift in
absorbance indicate reagent addi-
Limits are high A Mean +150% and tion problem.
low A Mean –50%
Result Monitor “A” assesses reagent delivery to cuvette.

M Methods 241
12-
MALB
12M Methods
Method Chemistry 0
First Cuvette (clean Sample, R1 and R2 Probes)

1 QC blank 340/700 nm
cuvette
2 R1ARM (well 3 or 6) 80 µL NaOH, 211 µL (H2O) N
4 R2ARM (well 3 or 6) 80 µL NaOH, 100 µL (H2O) N
Section Cuvette (test)

1 QC blank - R0 340/700 nm
2 R1ARM Aspirate:(PR) 76 µL, (buffer) 299 µL N
Dispense: 364 µL
4 READ R1, R2 340/700 nm
5 R2ARM Aspirate: 96 µL Y
Dispense: 76 µL
READ R4, R3 340/700 nm
Read 4 not used in the calculation of results
Method Specifics 0
• PETINIA, pseudo-endpoint, bichromatic 340/700 nm

• Result monitor A (limits + 4.0/-0.5) monitors particle reagent and sample addition

242 M Methods
• Two-cuvette method: Cuvette 1 is used to wash sample, R1 and R2 probe tips are not
used in result calculation.
• Sample volume 17 µL, autodilute volume 2 µL (dilution factor 8.5)
Calculated Results Associated with MALB

With the addition of a new enzymatic creatinine method (EZCR) on the Dimension® sys-
tem, the MALB/Creatinine ratio calculation has been revised.
With newer Dimension® software versions that include the EZCR method, the MA/CR will
calculate with either CREA or EZCR creatinine methods. See EZCR method sheet for SW
versions.
Calculated results Microalbumin/Creatinine ratio use the following equations:
MA/CR:
MA = MALB and CR = CREA or EZCR
MALB (mg/L)/Urine creatinine (mg/dL) x 100 = [MALB/CREA(EZCR)] x 100
MA/CR ratio is reported with the units mg/g.
Troubleshooting 0
Accuracy
• MALB measures small amount of albumin in urine.
- Extremely sensitive to carryover of albumin in urine.
- Check sample probe, IMT probe and drains.
• Turbidimetric assay.
- Recalibrate after source lamp replacement.
- Check/clean windows.
Imprecision
• MALB measures small amount of albumin in urine.
- Extremely sensitive to carryover of albumin in urine.
- Check sample probe, IMT probe and drains.
• Sensitive to fluidics delivery.
- Check R1 and R2 alignment.
- Check R1 and R2 pumps and syringes.
- Run R1BS and R2BS.
- Check R2 ultrasonics.
- Check sample and IMT probes.

M Methods 243
Interpretation of XLINK Data

• Cuv# (read 1) = blank cuvette read, empty. This cuvette is used only to wash sample
and reagent probes with NaOH.
• Cuv#2 = test cuvette with 5 photometric reads.
Read 2 = r0 test cuvette empty.
Read 3 = r1 test cuvette after addition of particle reagent, buffer and sample.
Read 4 = r2 test cuvette, should be close to r1 if cuvette has no preagglutination.
Read 5 = r4 (not used in the calculation).
Read 6 = r3 final reaction read.
• Pol MAU - read 3 (340-700) - read 2 (340-700) - account for dilution factor and air cor-
rection.
• PartBlank = reagent blank after addition of particle reagent, buffer and sample
r1 (340-700) - r0 (340-700)
• FOD_340 = r3, if > 1700, it exceeds photometer limit (absorbance error).
• Nonsp = slope between r2 and r1. If > 110, preagglutination or foaming occurring,
should be flat (340 read only).
• MonoPR = r2 at 340 - r0 at 340 to check particle uniformity. If > 1700 (absorbance
error).
• Check 700 = r2 at 700 - r0 at 700 reaction cuvette. If > 700, foaming (abnormal reac-
tion).
• Dye Ab and Dye Buffer - used for internal troubleshooting only.
Result Monitor
Tab. 70 Limit Table

A 340/700 20 250 4.0 0.5 abnl Active
assay

MALB A reagent blank after addition of par- To distinguish if reagent or sample,
ticle reagent, buffer and sample. check r2 (it should be close to r1).
R1 (340/700) - r0 (340/700) Increased MAU indicates particle
Limits are +4.0 and -0.5. reagent preagglutination or foaming.
Check R1 probe, rerun sample on
dilution.

244 M Methods
MBI 12.1
Method Chemistry 0
Tab. 72 Method Chemistry

1 R1ARM (R1) 288 µL, (H2O) 10 µL N
3 R2ARM (R2) 58 µL, 10 µL Y
Method Specifics 0

• Flex® type = 6-well.
• Although CKMB is not covered by IFCC enzyme standardization, the diagnostic rela-
tionship between Total CK and CKMB warrants development of a matching CKMB
method. The calibrator is traceable to IRMM – IFCC certified reference materials
• Calibrated with CKI/MBI Calibrator, Cat. No. DC32.
• All liquid reagents.
• Sensitive to cuvette temperature.
• Sensitive to water temperature used to hydrate QC.
• Calibrators, QC product and samples degrade quickly when left out at room tempera-
ture.
Troubleshooting 0
• Carryover pair in software 10.0.5 for Dimension®CHK Flex® solution. This solution can
cause interferene with MBI.

M Methods 245
- DABS,MBI
- HABS,MBI
- NAOH,MBI
- R1BS, MBI
- R2BS, MBI
- RIMS, MBI
- SABS, MBI
- SCHK, MBI
- W1BS, MBI
- W2BS, MBI

246 M Methods
METH 12.2
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Methadone, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance
- If diluted sample still has absorbance errors, analyze the sample by an alternate
method.

M Methods 247

Low ‘A’ Error

• Root Cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
- Sample turbidity. Centrifuge sample and rerun the assay after centrifugation.
Inaccuracy
drugs. Refer to Syva Emit® Drugs of Abuse cross-reactivity list and method insert
sheet..
• Does not detect EDDP metabolite.
Imprecision
• R1 probe.

248 M Methods
MG 12.3
Method Chemistry 0

1 R1ARM (R2) 100 µL, (H2O) 350 µL Y

1 R1ARM (R1) 100 µL, (R2) 100 µL(, H2O) 250 µL Y
Method Specifics 0

• Type ‘a method.
• 6-well Flex®
• Two cuvettes; cuvette 1 is for sample blanking.
• Higher MG results may be observed using the revised MG depending on the bilirubin
concentrations in the samples.
• Triglycerides at 600 mg/dL does not affect the MG result (<0.1 mg/dL) at a magnesium
concentration of approximately 2.0 mg/dL. The effect of 3000 mg/dL of triglycerides is
less than 0.2 mg/dL at the same magnesium concentration (2.0 mg/dL).

M Methods 249
• Hemoglobin at 1000 mg/dL has no significant effect (<0.1 mg/dL) on the rMg results as
stated in the IFU. However, Mg is present inside RBCs. The intracellular Mg concentra-
tion is greater than the extracellular Mg concentration. Therefore, hemolysis can cause
spuriously high Mg results.
Troubleshooting 0
• Interfering methods: ALP, ALPI

• First test, Mg++ high after system check – possible carryover from sample drain.
• SABS/CHK high after system check – sample drain carryover.
- ALP, MG
- ALPI, MG
Result Monitor
Tab. 73 Limit Table
Rslt Mntr Optical Fil- Minimum Maxi- Above Below Error Mes- Status
ters Reps mum Mean Fac- Mean Fac- sage
Reps tor tor
A 600/510 30 250 +10 SD -10 SD abnl assay active
B 293/700 60 250 2.0 0.85 abnl assay active

250 M Methods

MG A on reagents only. Check MTB delivery by R1ARM.
Endpoint at (r2) air blanked. Check Wells 1-3, all liquid reagent.
Bichromatic at reagent max (600/510)
Limits are mean ± 10 Σ∆σ
Note: This reading is taken from sec-
ond cuvette.
B checks for sample addition.. Detects lack of 2 µL sample delivery.
Endpoint at (r3), air blanked. Flags aqueous samples.
Bichromatic, at protein max (293/700) Errors are not reported.
Note: This reading is taken from sec-
ond cuvette.

M Methods 251
MMB/LMMB 12.4
Method Chemistry 0


1 R1ARM (R4:CPRG) 91 µL, (H2O) 224 µL Y
Method Specifics 0
• MMB and LMMB methods are identical except LMMB has lower put up controlled by
software for low volume.
• LMMB is available only on the Dimension® Xpand® system using software revision
6.1.1 or higher.

252 M Methods
• MMB Reagents:
Well 1,2 - Conjugate
Well 3,4 - 2 tables/well, CrO2 hydrated with 1,300 µL of CrO2 diluent in well 8
Well 5,6 - 3 tablets of CPRG hydrated with 1,500 µL of CPRG diluent in well 7.
Well 7 - CPRG diluent
Well 8 - CrO2 diluent
• Type ‘c’ method {* requires pre-processing *}
• Extended read method (Level = 4).
• Simultaneous format, CPRG detection.
• One step immunoassay based on sandwich principle (beta-galactosidase label).
• Flex® type = 8 well Flex®.
• HM RxL method bichromatic 577 nm, 700 nm
• Calibration type: logit, extended read, trip factor needed.
Do not fake calibrations or copy coefficients. A full calibration is required.
• Calibration slope range: 0.95 - 1.05
• Result Monitor: NOT AVAILABLE
Troubleshooting 0
• FOD error will overwrite “absorbance” error (mA > 2000).

• FOD error will enable auto-dilute.
• Assay range is 0-300 ng/mL. An error occurs if “FOD limit is > 2000 mA and or 300
ng/mL analyte. The “assay range” message will point ot the need for autodilute (30 µL
instrument performs autodilution) or manual dilution steps to occur on that high sam-
ple. Sample size is 60 µL.
The message “diluted” appears on printout on any sample
• If (cro2 < 56 || cro2 > 231)
FOAM_ERROR;/* cro2 check, abnormal reaction
• If (rgBlank < 50 || rgBlank > 500)
FOAM_ERROR;/* R1 reagent check, abnormal reaction

M Methods 253
• Abnormal reaction reagent blank flag. This flag is used to assess the activity of the
CPRG reagent using a reagent blank upper and lower limit check. The error occurs if
the blank mau exceeds the limits.
Lower limit = 50 mAU. Upper limit = 500 mAU.
The reagent cartridge contains THREE CPRG tablets. Look for floaters or tablets stuck
to lid stock. The proper hydration and dissolution is essential. If floaters are present a
pattern of high blanks descending to lower readings will occur.
The lower limit flag results when there is a problem with the CPRG hydration. Probable
cause may be a poor hydration of the well (suspect change reagent probes). The hydra-
tion occurs using the R2 probe.
The R1 probe transfers reagent to the cuvette. Look for improper volume in the well.
Correct well volume will allow for approximately 0.3 mL dead volume to remain. Sus-
pect the 8th, 9th or 10th tests in a well to be low on 577 nm readings. Conversely sus-
pect poor dissolution if a pattern of the 1-7 tests may show inaccurate readings.
Proper tablet dissolution and good mix of chrome is critical. Avoid resettling of chrome
in well with good mix and remix (ultrasonics R2 delivery).
Two chrome tablets must dissolve for good working reagent status. By design, there is
900 µL is not present, then proper hydration is not taking place. If a failure occurs
change R2 probe as it may be worn, clogged or misaligned.
Ultrasonics problems such as worn transducers or improper U/S settings may cause
mix problems that may produce a weak mix and a poor dissolution of the chrome tablet.
Change probes and/or transducers, check U/S settings. Look for residuals of any poorly
dissolved tablets physically in reagent well.
• Transfer steps from reaction vessel to cuvette must be accurate with 40 µL of sandwich
from reaction vessel being transferred. If more chrome is transferred then imprecision
will occur. Change sample probes, change wash probes, check for vacuum failures and
inspect for chrome clumping due to fibrin and poor preanalytical sample handling.

254 M Methods
MPAT 12.5
Method Chemistry 0
First Cuvette Processing (Low Range)

1 R1ARM (R2: Part Rgt) 80 µL, (R1) 190 µL, (H20) 35 Y
µL
2 SAMPLE (Sample) 5 µL, (H20) 40 µL Y
3 PHOT READ softread 340/700 nm
5 R2ARM (R3: Ab) 70 µL, (H20) 40 µL Y
Second Cuvette Processing (High Range)

1 R1ARM (R2: Part Rgt) 64 µL, (R1) 152 µL, (H20) 35µL N
2 SAMPLE (Sample from cuv. 1) 35 µL, (H20) 34 µL Y
4 R2ARM (R3: Ab) 70 µL, (H20) 35 µL Y

M Methods 255
Method Specifics 0
• MPAT is sold as Cat No. DF115 (OUS) and DF215 (US). DF215 was cleared for use
with EDTA plasma only. Both catalog numbers use the same method parameters for
processing.
• MPAT uses a logit calibration. All terms will change with calibration except the C4; C4 is
0.5.
• Turbidimetric method – uses inner detection cell only.
• Inverse standard curve – the lower the mA, the higher the µg/mL result.
• Recalibrate if the source lamp, optical filter or photodiode is replaced.
• MPAT uses two cuvettes – second cuvette uses prediluted sample transferred from first
cuvette. Assay uses a blended rate calculation (combine = rate (cuvette 1) + rateb
(cuvette 2)).
• Type ‘b’ method
MPAT Reagents
• Well 1, 2: Particle reagent (liquid) (10 tests per well)
• Well 3: empty
• Well 4, 5: Antibody reagent liquid (10 tests per well)
• Well 6: empty
• Well 7, 8: Assay Buffer (liquid) (14 tests well 7, 6 tests well 8
Troubleshooting 0
eter cables are not interfering with the photometer. Lube the photometer bearing.
• Make sure that the reagent has not been frozen, either by the instrument, the refrigera-
tor or during shipping, since this may alter Particle Reagent and can cause gross impre-
cision.
• Due to dynamic assay range, 0.2-30 µg/mL, the assay is susceptible to imprecision at
both ends of the curve. This is usually observed during calibration, especially at the cali-
brator Level 5. If level 5 appears to be imprecise, run 5-test over 2 wells at one of the
troubleshooting levels. If troubleshooting guidelines were not met, troubleshoot the
sample and reagent arms and ultrasonics.
• “FOAM_ERROR” occurs if “nonsp > 60” or “< –20”
nonsp = detects non-specific particle aggregation rates prior to antibody. For example,
if a small fibrin clot is added to the cuvette, the monochromatic rate between r2 and r3
would be abnormal and an error message would be printed.

256 M Methods
• “FOAM_ERROR” occurs if “part” or “partb < 150”

Particle blank = ensures that particles were delivered and not short-sampled. Check R2
probe and fluidics.
• “FOAM_ERROR” occurs if “check700” or “check700b > 100”
• “below assay range” samples should be confirmed by dilution with an equal volume of
calibrator or control product of a known value. If the calculated sample concentration
confirms the concentration to be < 0.2 µg/mL, the result should be reported as “less
than 0.2 µg/mL (0.62 µmol/L).” Consult the Operator’s Guide for further information.
• “above assay range” samples must be diluted manually. Recommended diluent for
manual dilution is MPAT Calibrator level 1. Samples should be diluted 1 part sample
and 1 part MPAT Calibrator level 1, and repeated with the dilution factor of 2 entered.

This flag represents final absorbance at 340 nm for the last read. It ensures that the absor-
bance values used to calculate analyte concentration did not exceed the photometer detec-
tion limits (FOD) for the analyzer. The error may occur if there is non-specific aggregation
due to abnormal proteins or grossly turbid or lipemic samples.
If (fod>1700) FOD_ERROR
Low “A” Error (IOD ERROR)

This flag is intended to detect the addition of particle reagent and can sometimes tell if the
particles aggregated in the Flex®. The measurement is taken on both reaction curves.
If(part<150) IOD_ERROR
If(partb<150) IOD_ERROR
Assay Range
Result flags will accompany the numerical value if the sample concentration is below or
above the assay range (AMR).
Assay Range (results below the AMR)

in the patient sample and there was no instrument malfunction. If the calculated sample
concentration confirms the concentration as <0.2 µg/mL (0.62 µmol/L), the result should be
reported as “less than 0.2 µg/mL (0.62 µmol/L).” Refer to the Operator’s Guide for further
information.
Assay Range (results above the AMR)

Dilute the sample with equal volume of MPAT CAL level 1 (0 µg/mL [0.0 µmol/L]). Enter dilu-
tion factor = 2. Rerun the assay.

M Methods 257
NOTE Autodilute feature is not available for the MPAT assay.
Below Assay Range

Result flag will be printed (without a numerical value) if the sample concentration is below
the calculation range.
in the patient sample and there was no instrument malfunction. If the calculated sample
concentration confirms the concentration as <0.2 µg/mL (0.62 µmol/L).”
Above Assay Range

Result flag will be printed (without the numerical value) if the sample concentration exceeds
the AMR.
Dilute the sample with equal volume of MPAC CAL level 1 (0 µg/mL [0.0 µmol/L]). Enter
dilution factor = 2. Rerun the assay.
NOTE Autodilute feature is not available for the MPAT assay.
Possible causes:
• Photometric issues such as weak source lamp, dirty cuvette windows
• R2 probe misaligned or worn
• Reagent mixing inadequate due to R2 probe ultrasonics
• Sample probe misaligned or worn
• Sample mixing inadequate due to sample probe ultrasonics
• Flex® reagent cartridge exposed to freezing conditions
Within-lot Inaccuracy
Possible causes:
• Calibration drift due to reagent or instrument instability
• Incorrect handling of QC material
• QC material deterioration
• Photometric issues such as weak source lamp or photodiode, or dirty cuvettes and win-
dows

258 M Methods
Result Monitor
NOTE “abnormal reaction” report messages has higher priority

over “abnormal assay.” Only the highest priority message
will appear on the printout even though there may be more
messages affecting the test result.
Tab. 74 Limit Table

A 340/700 40 250 1.5 0.5 abnl Active
assay
B 340 50 250 1.5 0.5 abnl Active
assay

M Methods 259
MYO 12.6
Method Chemistry 0

2 SAMPLE 20 µL, (H2O) 75 µL N
3 Incubation Incubation 211 sec, Suck vessel dry
5 R2ARM (H2O) 100 µL Y
First Cuvette

2 PHOT READ 577/700
4 PHOT READ 577/700
5 PHOT READ 577/700
6 PHOT READ 577/700
Method Specifics 0
• RF422A catalog number.

260 M Methods
• MYO reagents:
Well 1 - conjugate
Well 2 - empty
Well 3 - 1 tablet CRO2 hydrated with 1,800 µL of chrome tablet diluent in well 8
Well 4, 5, 6 - 2 tablets/well, CPRG tablets are hydrated with 1,400 µL CPRG diluent in
well; 7 + 400 µL CPRG H2O
Well 8 - Chrome table diluent
• Sequential format, CPRG detection.
• Two-step immunoassay based on sandwich principle (beta-galactosidase label).
• HM RxL method bichromatic 577 nm, 700 nm.
• Calibration type: logit, extended read, trip factor needed.
Do not fake calibrations or copy coefficients. A full calibration is required.
• Calibration slope range: 0.95 - 1.05.
• Assay range is 0-1000 ng/mL. An error occurs if “FOD limit is > 2,000 mA and / or 1,000
ng/mL analyte. The “assay range” message will point to the need for autodilute (2 µL
instrument performs a 1:10 dilution) or manual dilution steps to occur on that high sam-
ple. Sample size is 20 µL.
Troubleshooting 0
Result Monitor
Tab. 75 Limit Table

A 700 15 250 1.20 0.80 abnl Active
assay

MYO A on reagents. Check wells 4, 5, 6 for tablet hydra-
CPRG hydration. tion (R2ARM).
Limits are mean ±20%. Check CPRG delivery R1ARM.

M Methods 261
Error Messages
Abnormal Assay
The results monitor feature monitors the CPRG reagent. The abnormal assay flag will be
generated if the reagent blank exceeds the above mean factor or is less than the below
mean factor.
Troubleshooting Steps:
• Hydration of CPRG tablets
- R2 alignment, especially to reagent cartridge.
- R2 probe tip alignment
- R2 ultrasonics components (transducer and pcb).
• Delivery of CPRG by R1 arm.
- R1 alignment, especially to cuvette.
- R1 probe tip replacement.
- R1 tubing, syringe, solenoid.
Abnormal Reaction
CPRG Reagent
• If the reagent blank (RM A on filterdata) is less than 50 or greater than 500, an abnor-
mal reaction flag is generated. This is in addition to the Result Monitor feature.
• The upper limit flag occurs when the reagent blank has excessive activity causing an
incorrect analyte result. The lower limit flag occurs when there is a CPRG tablet hydra-
tion problem.
• Troubleshoot R2 alignment, R2 probe tip, and R2 ultrasonics components.
Chrome
If the chrome value (CrO2 on filterdata) is less than 38 or greater than 128, an abnormal
reaction flag is generated. The single chrome tablet must go into solution for good working
reagent. The reagent cartridge has single common chrome well. Chrome must be added
correctly to the vessel and transferred from vessel to cuvette.
Troubleshooting Steps
1. R2 probe worn, clogged or loose.

2. R2 probe misaligned.
3. Sample probe alignment to HM and to cuvette.
4. Wash probe alignment.
5. Ultrasonics components (transducer, pcb).
6. Refer to SB D-00022 (page 2) for additional chrome troubleshooting tips.

262 M Methods
Outliers (High or Low with no Error Code Triggered)
Fibrin Issues
1. Repeat the initial sample tube on a fresh well. Ensure no fibrin issues are associated
with the sample collection tube. Also check sample height into tube.
2. If in a cup, pour a fresh cup and repeat on fresh well. Ensure no fibrin issues are associ-
ated with the sample.
If outlier still exists after repeat processing, obtain XLINK or filterdata.
- Check CRO2 reading or Blank readings
- Compare mau readings from the outlier mAUs to a good result on XLINK or filterdata.
- If CRO2 readings are erratic, replace wash probes, align properly.
- If blank readings are erratic, check Milipore or water system. Not usually a MYO
issue.
- CHEMWASH, ensure bottled is filled, and no crimps in Chem Wash tubing are
present.
- PROBE WASH, ensure bottled is filled, and no crimps in tubing.
- Sample Probe, ensure alignment is good and that the probe is not worn. If worn,
replace and align.
Hook Effect
Patients with advanced muscle effect disease or muscle trauma may have extremely ele-
vated MYO results.
MYO method shows no hook up to at least 300,000 ng/mL [µg/L]. If extremely elevated
results are suspected, the sample should be processed both undiluted and manually
diluted 1:100 with sample diluent.

N Methods 263
13-
NAPA
13N Methods
Method Chemistry 0

5 R2ARM (R3) 80 µL, (H20) 40 µL Y
Total Cuvette Volume: 468 µL.
Method Specifics 0

• NAPA uses a logit method for calibration. All terms will change with calibration, except
the C4; C4 is 0.5.
• Put up: 20 tests per reagent cartridge.
• Whole blood treated with EDTA, sodium heparin, lithium heparin, can be used for this
assay.
• Specimens should be collected by normal procedures.
Troubleshooting 0
• Make sure that reagent has not been frozen by the instrument or the refrigerator, since
it may alter particle reagent and can cause gross imprecision.

264 N Methods

This flag represents final absorbance at 340 nm for the last read. It is used to check for the
final absorbance reading. This flag ensures that the absorbance values used to calculate
analyte units did not exceed the photometer detection limits (final optical density or FOD)
of the analyzer.
if (fod > 1700)
FOD_ERROR
Troubleshooting
This error occurs if there is non-specific atypical aggregation due to abnormal proteins or
grossly turbid or lipemic samples.

This flag monitors the particle reagent to ensure that an aggregation reaction has not
already occurred before the test measurement occurs. This measurement is similar to that
of Result Monitor A. However, the measurement has not been corrected for background
mAU (i.e. has not had absorbance at 700 nm subtracted).
if (monoPR > 1700)
IOD_ERROR;
Troubleshooting
Check for particle reagent that may have aggregated possibly due to freezing in the refrig-
erator or reagent tray.

It checks to make sure the particles were added and can sometimes tell if the particles
aggregated in the Flex® on it's own. It checks that the particles were delivered and not short
sampled. This flag monitors the identical phenomenon as Result Monitor A.
if (part1 < 150)
IOD_ERROR;
Troubleshooting
Imprecision of pipetting both buffer and particle reagent. This may be caused by particle
reagent delivery problems by R1 reagent arm or gross fluidic problem from a clogged
probe, crimped reagent tubing, leaking or loose fitting on pump valves or bad R1 syringe
tips.

N Methods 265

This flag checks for aggregation when particles and sample are present (No antibody is yet
added at this point). It's a check to make sure that NOTHING in the sample causes non-
specific (Nonsp) aggregation of the particles. No change in values should occur until the
antibody is added. If there is a change greater than the limits, the result gets flagged for
non-specific aggregation.
This flag monitors the identical phenomenon as Results Monitor B.
if (nonsp > 50 || nonsp < -30)
FOAM_ERROR;
Troubleshooting
• Check for non-specific aggregation prior to the addition of the antibody reagent.
• Sample quality issues such as fibrin strands, small fibrin clot is added to the cuvette.

Limit is 100 mau. It checks for foaming, non-specific particle aggregation, excess turbidity
prior to antibody addition. Checks for foaming, air bubbles, turbidity, or scatter in the
cuvette.
if (check700 > 100)
FOAM ERROR;
Troubleshooting

Below Assay Range

Below assay range errors will be printed (without the numerical value) if the sample con-
centration is below the calculation range.
Troubleshooting
Concentrations below assay range:

266 N Methods

• If the calculated sample concentration confirms the concentration to be < 0.5 ûg/mL, the
result should be reported as “less than 0.5 ûg/mL”.
Above Assay Range

Above assay range errors will be printed if the sample concentration is above the calcula-
tion range.
Troubleshooting
Dilute sample with equal volumes of drug free serum or DDRUGCII level 1. Multiply by dilu-
tion factor or 2.
NOTE Autodilute feature is not available for the NAPA method.
Possible Causes:
• Flex® reagent cartridge exposed to freezing conditions.
Possible Caused
• Calibration drift due to reagent or instrument instability.

N Methods 267
Result Monitor 0
NOTE “abnormal reaction” report message has higher priority over

“abnormal assay”. Only the highest priority message will
appear on the printout even though there may be more mes-
Tab. 77 Limit Table
tor tor
B 340 50 250 1.5 0.5 abnl assay active

268 N Methods

NAPA Reagent QC - 1 calculation: • Precision of pipetting both buffer
end-point (r1), air blanked, bi-chro- and particle reagents.
matic (340/700) • Not enough particle reagent
Limits: Mean ± 50% delivered by R1 reagent arm or
This monitors the particle blank for gross fluidic problem from a
each test. The particle blank absor- clogged probe, crimped reagent
bance is taken after the addition of tubing, leaking or loose fitting on
particle and assay buffer and sam- pump valves or bad R1 syringe
ple. This measurement has also tips.
been corrected for by any back- • Insufficient volume of either parti-
ground mAU (and absorbance at cle or buffer in well would trigger
700 nm has been subtracted). this flag.
• Particles which may have agglu-
tinated in the Flex®
would (i.e. frozen flex).
• If a single patient sample is
flagged with abnormal assay
error, analyze sample by an alter-
nate method since it is possible
there is an interfering substance
present in the sample.
Reagent QC - 2 calculation: rate (r2 • Unstable particles would trigger
- r1), non air blanked, monochro- the flag.
matic (340) • Patient samples with specific
Limits: Mean ± 50% interference which have not been
This monitors non-specific aggluti- identified may possibly trigger an
nation reactions which may occur (in agglutination reaction and would
absense of antibody). Prior to anti- be identified by this flag.
body reaction, the mAU should have • If a single patient sample is
negligible increases over time. flagged with abnormal assay
error, analyze sample by an alter-
nate method since it is possible
there is an interfering substance
present in the sample.

N Methods 269
NTP/LNTP 13.1
Method Chemistry 0

1 -840.8 sec Sample (Sample) 8 µL, (H2O) 14 µL Y
2 -821.2 sec R2ARM R2 (Chemibead-Ab) 20 µL Y
R2ARM R1 (Biotinylated-Ab) 20 µL
(H2O) 10 µL
3 -353.4 sec R2ARM R3 (Sensibead) 15 µL, (H2O) 10 µL N
4 -122.7 sec R2ARM R4 (Assay Buffer), 100 µL, (H2O) 53 µL N
5 0 sec LOCI READ LOCI read vessel (2 reads)
Method Specifics 0
• LOCI method, a homogeneous, sandwich chemiluminescent assay.

• NTP/LNTP methods are only available on the Dimension® EXL™ System with LOCI®
Module. The NTP/LNTP methods contain identical reagents and use the same calibra-
tor. The difference between the two methods is the amount of tests per Flex® reagent
cartridge. The LNTP configuration was designed to allow the lower volume user more
efficient utilization of all tests within the open-well stability time period.
• Flex type = 8 well, all liquid reagents. All NTP/LNTP reagents are liquid; however,
chemibead and sensibead reagent wells are mixed by the instrument when the well is
first punctured. Mixing is performed by the R2 or R3 probe (RMS). Mixing is accom-
plished by aspirating a fixed volume of reagent from the well and then dispensing it back
into the same well (referred to internally as “Sip and Spit mixing”). This process is per-
formed automatically when a new chemibead or sensibead well is punctured. This pro-
cess can be pre-programmed using the inventory/hydration screen.
Tab. 79 NTP/LNTP Flex Configuration (8 Well Flex)

1,2 Biotinylated Ab Liquid
3,4 NT-proBNP Chemibeads Liquid
5,6 Streptavidin Sensibeads Liquid
7,8 Assay Buffer Liquid

270 N Methods
• Coefficients: C0 = -35.0, C1 = 7360.0, C2 = -1.1, C3 = 22314.0, C4 = 0.01

• The NTP/LNTP method uses a 5-level LOCI NTP/LNTP calibrator, RC623. During cali-
bration each calibrator level is analyzed for three replicates. The NTP/LNTP method is
a logit method, and the calculated slope (m) should be between 0.95 and 1.05. The
intercept (b) should be 0.0 or clinically insignificant. The correlation coefficient (r)
should be between 0.990 – 1.000.
• The assay range for the Dimension EXL NTP/LNTP method is from 5 to 35000 pg/mL.
The NTP/LNTP method reports to 0 decimal places. Samples with results in excess of
35000 pg/mL can be reported as > 35000 pg/mL or can be manually diluted. Manual
dilutions should be performed with Sample Diluent (Cat. No. 791092901) to obtain
results within the reportable range. The recommended dilution factor is 2. Enter dilution
factor on the instrument and reassay. The resulting readout is corrected for dilution.
Dilutions of 1:5 have demonstrated maximum deviations of 20% from the theoretical
value.
Troubleshooting 0
• XLINK instructions can be found in the Dimension EXL XLINK Functional Description
(DCIN-A03.850.15 / Introducing Xlink). Chemdata file will contain summarized
NTP/LNTP QC data. LOCIDATA file contains LOCI reads and module level checks.
Standard Dimension filterdata holds no NTP or LOCI method information. LOCIDATA
can be obtained via the snapshot directory. Software versions 9.0SP3 and higher will
have the “get LOCIDATA” command, which will pull most recent LOCIDATA (similar to
“get filterdata” command).
• LOCI NTP/LNTP calibrator is a frozen calibrator and is sensitive to storage and han-
dling conditions. See calibrator IFU for storage and handling conditions.
handling conditions. Both BioRad and MAS cardiac control products indicate that the
product is stable within their claims when product is stored in a non frost-free freezer.
1. Pre-read
2. Assay read
3. Gain read
The Pre-read and Gain reads produce diagnostic information to identify a malfunction-
ing LOCI detector, shutter, or light-emitting diode (LED). Both occur on an empty read
chamber with no vessel present. For NTP, the Assay Read is composed of four assay
and after a 100 msec gate delay, the chemiluminescent signal is collected for 1000

N Methods 271
msec. Total signal, reported in kilocounts (kcounts – Found in the LOCIDATA file under
the Primary Column with LEGEND: LOCI NT-pr. This is the sum of the 2 assay read
cycles in counts / 1000).
kcount less than 1/2 the mean recovery of the level A calibrator (zero calibrator). Fre-
quent occurrence of this error indicates either the wrong calibrator level run or a reagent
delivery issue with the chemibead or biotinylated antibody.
Results Monitor
• The NTP/LNTP method uses the ReadVF as a result monitor, this is found in the LOCI-
DATA file in the column ASY Tot VF. ASY Tot VF is the sum of the four ASY VF Rd. The
tion photocell. This read occurs when the sample reaction vessel is in the LOCI reader.
An unusually high ReadVf occurs when there is no or a drastically reduced amount of
sensibead reagent in the assay. The methpar is set up to create an “Abnormal Assay”
error in this case. Likewise, a low ReadVf can occur if the sensibeads have settled and
are not sufficiently resuspended during the sip and spit mix routine.
is required to reliably detect this type of error. The first 30 results with a new flex lot or
monitor. It passes if it is within ±20% of this average and is then included in the aver-
used.
ing Legends: tVFR mean, tVFR sd, lo limit, and high limit.
• Abnormal Assay Troubleshooting should include checking R2 and R3 alignment to flex,
Contamination Read
under column Contamination. In prior software versions the Contamination column will
always read “0” – the contamination read can be calculated by multiplying the PRE Tot
CPM column by 3.3333. The contamination value is typically below 45 counts. If a con-
tamination read exceeds acceptable limits it will produce Error 849 - Failed Reader
Contamination Check and the test will not process.

272 N Methods
• Should the system flag a contamination error, the LOCI vacuum cup should be replaced
along with the LOCI insert and retainer rubber seal. LOCI arm alignments should be
performed following replacement. Prior to replacing the vacuum cup, insert and retainer
seal, the HM incubation wheel should be examined to ensure there is not reagent spill-
age that could contaminate the vessel. Close examination should also be done in the
R2 delivery area. Should there be any stray fluids, cleanup should be performed along
with realignment of the R2 arm.
Illumination Read
The Illumination read is a measurement taken with the illumination photodiode at the begin-
ning of the pre-read. Acceptable range of the Illumination read is between 150,000
-500,000 counts. In software version 9.0SP3 and higher the Illumination Read should
appear in the column Illumination in the LOCIDATA file. In prior software versions the Illu-
mination column will always read “0” – the illumination read can be calculated by multiplying
the PRE Tot VF column by 2. The illumination value must be within 2.5% and 7 standard
deviations from the mean. If the value is greater that 7 standard deviations it must be within
1% of mean. If the illumination read exceeds acceptable limits it will produce error Error
850 - Failed Reader Illumination Check. Illumination failures are primarily noise related and
the electrical components should be inspected to ensure cable routing is correct. If problem
persists change LOCI board followed by the reader. If noise in the illumination value is
found and corrected the LOCI statistics file should be reset.
Gain Read
values output into the LOCIDATA file. These are GAIN Tot CPM, GAIN Tot VF, the sig-
nal as measured by the gain photodiode, and the ratio of the two or Relative Gain.
Acceptable Relative Gain ratios are between 1.0 - 8.5. Values must also be within 4% of
the running mean and 5 standard deviations.
1.0% of the course of a month. If a customer complains of a QC trend over time or not
meeting the claimed calibration interval, the Relative Gain ratio should be checked.
Take the mean of the Relative Gain ratio reads from Day 1 and compare with the mean
of Relative Gain ratios from Day 30.
below 1.0. This, however, should not happen for years of use. Persistent gain read
Non-Delivery of Reagents or Samples

• Completely missing b-Ab reagent eliminates the specific signal and is expected to
result in signal counts slightly higher than calibrator level 1. It would be impossible to
flag this failure. Partially missing b-Ab is not easily identifiable. The amount of signal
loss depends on the fraction that is missing.

N Methods 273
• Completely missing chemibead reagent eliminates the specific signal and most of the
background. Signal counts will be extremely low and would result in a “below assay
range” error.
• Non-delivery of sensibead reagent is flagged by Abnormal Assay message - see
Results Monitor .
• Completely missing sample eliminates the specific signal and is expected to result in
signal counts slightly higher than calibrator level 1 and would not be flagged. This is due
to the increased “cross-talk” between chemibeads and sensibeads that results from a
smaller reaction volume and to the absence of matrix proteins. Partially missing sam-
ple is not easily identifiable. The amount of signal loss depends on the fraction that is
missing.
Recovery of Quality Control and Proficiency Materials

While patient samples show excellent agreement between the Dimension® NTP/LNTP
method and Dimension Vista® PBNP method, the NT-proBNP antibodies have a different
affinity for native (patient) NT-proBNP peptides versus synthetic NT-proBNP peptides used
in proficiency and quality control samples. Along with differences in the architecture of the
Dimension Vista® and Dimension® EXL™, the Dimension® NTP/LNTP method parame-
ters (method timing) are different than the Dimension Vista® PBNP method. All of these
factors contribute to the differences in recovery of QC and proficiency sample material.

274 O Methods
14-
OPI
14O Methods
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Opiates, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance

O Methods 275

method.
Low ‘A’ Error

• Root Cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
Inaccuracy
sheet..
Imprecision

276 O Methods

• R1 probe.

P Methods 277
15-
PALB
15P Methods
Method Chemistry 0

1 R1ARM (R1) 100 µL, (R2) 250 µL(, H2O) 100 µL N
2 PHOT READ 383 nm
Method Specifics 0

• Type ‘a’ method, all reagent delivery by R1 ARM. No mix after reagent addition to mini-
mize potential for foaming due to detergents and BSA in reagents. Sufficient mixing
occurs upon dispense.
• Sample-initiated reaction.
NOTE “Transformed” mAU is used in logit conversion to “weight”

the standard curve.
Troubleshooting 0
• “abnl assay” error occurs if Result Monitor “A” is “hi” or “lo.” Result Monitor monitors
consistent reagent delivery.
• High “A” error occurs if “FOD 383” >1600 mA. High “A” error occurs due to nonspecific/
atypical particle aggregation, grossly turbid sample, or if TGL >1000 mg/dL in conjunc-
tion with a high PALB.
• “abnl reaction” error occurs if “PartBlank” <350 mA. Not enough particle reagent deliv-
ered by R1 reagent arm or gross fluidic problem from a clogged probe, crimped reagent
tubing, leaking or loose fitting on pump valves or bad R1 syringe tips.

278 P Methods
• “abnl reaction” error occurs if “check700” >100 mA due to FOAM ERROR or nonspe-
cific particle aggregation.
• “abnl reaction” report message has higher priority over “abnl assay.” Only the highest
priority message will appear on the printout even though there may be more messages
affecting the test result.
Result Monitor
Tab. 80 Limit Table
tor tor

PALB A monitors “rgBlank” on particle Detects lack of particle reagent (R1),
reagent R1. End point air blanked, and Buffer (R2) delivery by R1arm.
monochromatic (383) mA Mean ± Results low due to 10% under deliv-
5% typical. ery.
Limits are Mean + 5% & - 5%

P Methods 279
PBNP 15.1
Method Chemistry 0

Clean probe after aspiration
Purge probe before aspiration
3 R2ARM (R3: tag conjugate) 40 µL, (H2O) 60 µL Y
Purge probe after dispense

1 R1ARM (R2: fadp) 30 µL (R1: apo) 30 µL, (H2O) 300 µL Y
Clean probe between aspirations
2 SAMPLE (sample from vessel) 40µL, (H2O) 50 µL Y
Mix vessel before aspiration

280 P Methods

1 R1ARM (R2: fadp) 30 µL (R1: apo) 30 µL, (H2O) 390 µL Y
Clean probe between aspirations
2 SAMPLE No sample addition N
Method Specifics 0
PBNP Well Flex® Cartridge Design
Fig. 5: PBNP Well Flex® Cartridge Design
PBNP Reaction (Simultaneous Format Cascade Detection PBNP Reagents)

• Two reads are taken: one long read and one short read.
R1 at 38 sec.
R2 at 104 sec.
R3 at 322 sec.

P Methods 281
• Two standard curves are generated and combined to one curve = combo curve.
Calibrator Long Short Combo

Level N Conc pg/mL MA read MA read MA read
L1 N=4 0 10 0 37
L2 N=3 300 100 3 125
L3 N=3 1500 500 27 465
L4 N=2 12000 >2000 285 4143
L5 N=3 30000 >2000 665 10519
• In a software routine the short reads and long reads are extrapolated to a combo curve.
• Four replicates at 0 to get better accuracy. More replicates = more accuracy, especially
if signal is low.
• Logit equation used with weighting to anchor the low level.
• Weights: L1-100, L2=50, L3=1, L4=1, L5=1
• Zero Limit (10.0) entered to transform negative numbers to zero. If numbers are below
-10, an error code (assay range) will be observed.
• Instrument blows cuvettes to keep constant temperature.
• Temperature sensitivity - 4% per degree, better than with other methods.
Troubleshooting 0
The PBNP method is susceptible to any variation in the instrument condition. Factors
affecting accuracy and precision performance include:
• Changes in chrome or blank values.
• Bacterial contamination
• Alignments.
• Photometer condition.
• Ultrasonics.
Chrome precision and water/reagent contamination are monitored with Abnormal Reaction
flags and Result Monitor.
Photometer condition and MAU reads can be checked using the Xlink function using Global
Xlink FD Extractor 3.1 or higher.
The most likely cause for low-end PBNP imprecision is alignments, chrome imprecision
and bacterial contamination of the water or Chem Wash systems.

282 P Methods
Possible Causes
• R2 probe misaligned or worn,
Possible Causes
• Photometric issues: weak source lamp or photodiode, dirty cuvette windows.
• Temperature of the reaction cuvette.
• Poor temperature control (e.g., running with lid up).
Calibration Scalers - Function

• There is a difference in antibody affinity between synthetic NT-proBNP (calibrator, com-
mercial QC products and surveys).
• PBNP method scalers are “equation factors” that have been predetermined in order to
provide consistent patient sample agreement across PBNP Flex® cartridge lots.
• Patient sample values in “calibrated Dimension®” analyte units are transformed through
an internal correction equation - the scaler routine-to-give the output in standardized
results.
• Equivalent to correlating Dimension® results to another lab system - in this case the
Elecsys proBNP method.
• Siemens provides the correlation function as an internal function as part of the Flex®
cartridge manufacturing process rather than having the user do the correlation.
• The net results of using the scaler routine are to ensure consistent patient sample
results across PBNP Flex® cartridge lots.
• If incorrect scalers are entered for a given method, inaccurate results would be
obtained.

P Methods 283
• Typical Monoclonal PBNP scaler values are; A=0, B=0, C=1, D=0. It is very important
that before calibrating each new lot of NT-proBNP, the scaler values entered into the
calibration screen be checked against those printed on the Flex® carton.
Fig. 6: Scaler Values
PBNP Specific Error Flags
Fig. 7: Abnormal Reaction- Case 1 Filter Data
Fig. 8: "Abnormal Reaction" Case 1

284 P Methods
Fig. 10: "Abnormal Reaction" Case 2 Filter Data

P Methods 285
Fig. 12: "Abnormal Reaction" Case 3 Filter Data

286 P Methods
Method Imprecision
See Service Technical Support Service Bulletin D-00023R.
Analyze in the following order:
1. Windows and Source Lamp.

For source lamp replacement, see Service Bulletin RxL-83, “Source Lamp Replace-
ment Requirements”.

P Methods 287
2. Chrome.
and good optics. Typical chrome precision is <5.0 SD. If the chrome values on the Xlink
data are imprecise (noisy).
- Check sample for particulate matter.
- Check wash station, incubation wheel, baseplate and reagent tray cover for splash-
ing.
- Check for bent or bad reaction vessel clips.
- Check for dirty or bad reaction vessel mixers.
- Check wash station alignment,
- Check for cleanliness of the wash probes.
- Check sample and R2 alignments (all).
- Check drains and check sample and probe wash delivery.
- Check for crimps in tubing or loose tubing (R2 and Sample).
- If chrome first result is high or low, suspect chrome dissolution/mixing.
- Check R2 ultrasonic and alignment. Ensure that the ultrasonics is firing correctly,
especially after the system is in Standby mode for a long time, such as a weekend.
3. Water / Reagent Contamination
enzymes act like conjugate (alkaline phosphatase) and will cause the blank rate to
- Very low mA (< 2 mA) may indicate missing tablets or non-hydration (coring by R2
during hydration).
- Review Xlink blank results for the following: An abnormal reaction error message
occurs if blank readings are PBNP > 130. Blank results normally increase a small
amount as the reagent well ages. It can increase as much as 20 to 30 mau during the
3-day life of the reagent well. Typical is 10-15 mau. An increase of 30 mau above the
manufacturing release blank data may indicate contaminated water or a contami-
nated reagent well. The manufacturing release blanks are typically: PBNP - 15 to 35
mau.
Reagent Contamination: Rapid elevation above manufacturing Blank value +30 mAU,
typically observed immediately or within 1 day.
Corrective Actions (in the following order):
- Ensure that Probe Cleaner is not empty and is flowing to the drain.
- Clean (Clorox) and align the R1 and R2 drain and the R1 and R2 probe (clean with

288 P Methods
Bacterial Contamination - Water: Steady rise of Blank above manufacturing Blank value
+ 30 mAU over a 3 day period. Gross bacterial contamination may start out (upon
hydration) above manufacturing Blank value + 30 mAU and continue to rise over the 3
days.
Corrective Action: If this is the first case of contamination, decontaminate both the
water system and the Chem Wash system. If this is not the first case, decontaminate
the water system back to the Millipore. If decontamination was performed during the
past month, consult Global Product Support before decontaminating again.
NOTE In most cases, contamination is within the hardware system/

fluidics of the Chem Wash system and not the fluid itself.
If the Chem Wash system is contaminated, the polished mAU of samples will trend
downward as the Chem Wash flushes the bacterial phosphatases out of the system,
with a corresponding downwards trend in analyte results. The effects of this contamina-
tion can be seen as soon as 30 minutes after Standby. To test for Chem Wash contami-
nation:
- Have the HM system in standby for 30 minutes.
- Using either TSH or CTNI method, run a sample of Level 1 calibrator or freshly
opened Chem Wash as a patient sample (n=10) as XQC. Review the polished mAU
on the filterdata and look for a downward trend with corresponding downward trend in
analyte results. A downward trend indicates the need to decontaminate the Chem
Wash system. Repeat the Chem Wash test. If the problem returns within the month, it
could indicate a severe contamination problem. Consult with Global Product Support
before decontaminating again.
Cascade methodology requires sufficient and stable (not changing) levels of dO2 con-
tent.
Changes of dO2 of 2 ppm between two measurements of Millipore® product water at
two points in time (not the same day) are suggestive that dO2 not stable and should be
further investigated. FT4 is the most sensitive Cascade method to changing dO2 lev-
els. FT4 requires dO2 content as close as possible to 7.0 ppm. See Service Bulletin
D-00016, “Millipore Aeration System.”
6. Magnetic Effects
NOTE Generally, magnetic effects causing result outliers occur

with low frequency.

P Methods 289
- Refer to Service Bulletin D-00067, “Magnetic Field Effects on HM Assays”, “Mag-

netic Field Effects on HM Assays REVISED” to identify potential stray magnetic fields
affecting chrome in the cuvette. A guideline is presented below to help with this iden-
tification.
- If present, stray magnetic fields are generally found in the baseplate area (near
cuvette position 22 and/ or position 44) or from the HM module and/ or photometer/
cuvette bearings.
- HM module bearing ring: A study was performed to observe the effects of magnetism
on cascade methods (CTNI, TSH, FT4) by using a highly magnetized HM module
bearing ring.
- Sample used was Chem Wash for CTNI, TSH, DPSA and L1 Cal-FT4.
- Conclusions:
- Greatest effect observed with CTNI and TSH.
7. Baseplate Area: Guideline Filter data Interpretation for Identifying Possible Stray Mag-
netic Fields
Stray magnetic fields generally exhibit themselves by lowering the active cuvette, 510
- Polished mAU on a zero sample is -3 to -8.
- Active is < Blank by 10 or more mAU’s on a sample with no analyte (Chem Wash or
0.00 patient results). Typically the Active- Blank = ±5. This is generally systematic
- The Read 4 - Read 2 mAU is <12 on a sample with no analyte (Chem Wash or 0.00
patient samples). This is systematic across multiple zero level samples. Normally,
this value is 20-30 mAU.
- Removing the chrome from the Flex® and replacing with water yields (Active=blank)
±5.
present on the instrument.
- You will notice from these graphs atypical shifts in mAU at the second and third pho-
tometric reads. This is indicative of possible stray magnetic fields in these areas of
the instrument (cuvette position 22 and/ or 44 for RxL).
Accuracy
Sample
• Bacterial contamination of water or Chem Wash systems.
• Particulates in the sample cause chrome clumping.

290 P Methods
• Missing or extra tables in the Flex® cartridge well.

• Under-hydration, perhaps due to coring.
Result Monitor
Fig. 16: PBNP Result Monitor
Fig. 17: Abnormal Assay A - Filter Data

P Methods 291
Fig. 18: Abnormal Assay A
Fig. 19: Abnormal Assay B Filter Data

292 P Methods
Fig. 20: Abnormal Assay B

P Methods 293

Tab. 82 Limit Table

A 700 45 250 1.40 0.80 abnl Active
assay
B 510/700 30 250 40 0 abnl Active
assay

294 P Methods

P Methods 295

PBNP Result Monitor A • Troubleshooting for chrome dis-
Flag compares the absorbance in solution/mixing (r2 probe/ultra-
the Rx cuvette to that in the blank sonics) if results are low and
cuvette. The difference should be trend or shift to normal
above 80 mAU. Result monitor A is (expected)
used to check for low or high CrO2 • Possible sample handling issue.
delivery. This is another layer of flag Note: The chrome value may not
protection for CrO2 delivery. Reps of be outside the result monitor
45 tests are used to average a mean limit; however, it may be atypical
from 3 well sets. There are 250 tests compared to all the other values.
buffer used for mean and SD calcu- See D-01171, Preanalytical Vari-
lation. Values outside of the 40 to able on Performance on the
200 range are stated not acceptable, Dimension® CTNI Method and
which his similar to FOAM-ERROR D-0244, Information on Speci-
(Ferr=3) in the methpar. men Preparation and Handling
Abnormal Assay “A” Low indi- for the Dimension® HM.
cates whether there is no color (or no • If low chrome occurs on more
CrO2) in the Rx cuvette or the col- than one sample, and dissolution
ored material (or CrO2) has leaked of the tablet is not the problem,
to the blank cuvette. consider the following:
Abnormal Assay “A” High suspect - check alignment of the wash
sample probe to vessel alignment, probes
chrome under hydration, chrome - replace cuvettes
remix problem, clogged wash probe - replace HM tubing harness
or bubbles, foaming, poor cuvette,
- evaluate pump panel (tubing,
low cuvette volume.
chemwash valve), tubing from
HM wash station cassettes to
the waste bottle, vacuum sen-
sor
- diluent aspirate lines reversed
• W1BS, W2BS is useful for trou-
bleshooting to detect problem in
waste station area. Load an
ABS/CHK reagent cartridge
manually as W1BS and another
as W2BS. Order W1BS (n=5_
using the ALT/GGT/LIP keys,
and W2BS (n=5) using the
ALT/GLU/MG keys. No sample is
required. A record of the results
obtained from System Check can
be found in Method Review,
W1BS using the ALT/GGT/LIP
keys, and W2BS using the
ALT/GLU/MG keys. Acceptance
criteria: 10% of carton value, SD
< 1.6.
Restricted 10.14 H DX GPS•D High chrome can be caused by
an underhydrated chrome well or
foaming. Foaming would most
likely be caused by the sample
probe.
296 P Methods
PCHE 15.2
Method Chemistry 0

1 R1ARM (R1) 300 µL, (H2O) 100 µL Y
3 R2ARM (R2) 50 µL, (H2O) 20 µL Y
Method Specifics 0

• Check theoretical coefficients: C0 = 0.000, C1 = 0.0464.
• Methodology – Butyrylthiocholine (BTC)
• There is no hydration QC for BTC tablets in wells 4-6.

P Methods 297
PCP 15.3
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Phencyclidine, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance
method.

298 P Methods

Low ‘A’ Error
• Root Cause:
High ‘A” Error
Abnormal Reaction
• Root Cause:
Inaccuracy
sheet.
Imprecision
• R1 probe.

P Methods 299
PHNO 15.4
Method Chemistry 0

1 R1ARM (R2) 40 µL, (R1) 145 µ(L, H2O) 180 µL N
4 PHOT READ 340/700 nm Y
5 R2ARM (R3) 40 µL, (H2O) 40 µL -
Method Specifics 0

• As with all PETINIA methods, PHNO is a nonlinear method with five C terms. All terms
will change with calibration, except the C4; C4 is 0.5.
since this may alter the Particle Reagent. Increases in temperature may also affect the
Particle Reagent.
Troubleshooting 0

300 P Methods
insert. If Arithmetic Error is generated on recalibration, calculate and accept the new
curve if acceptable calibration guidelines are met. Check QC.
• If source lamp is replaced, recalibrate.
Error Messages
Abnormal Reaction
• May be due to check700 (>100mA) or nonsp (>50mA).
• For check700 failure, examine optical system (especially source lamp) first, then sam-
ple probe and ultrasonics, then R1 probe. If occurring on a particular patient, there may
be an interfering substance in the specimen. Analyze by an alternate method or con-
tact GPS for assistance.
• For nonsp failure, look for causes of nonspecific aggregation such as fibrin, clots, or
temperature issues with particle reagent (see above).
Absorbance
• May be due to monoPR (>1600mA) or particle (<350mA).
• For monPR failure, check for particle reagent aggregated in Flex® and then check R1
tubing for crimps and leaks.
• For particle failure, check R1 tubing first, then check R1 probe and alignments.

P Methods 301
PHOS 15.5
Method Chemistry 0

1 R1ARM (R1) 50 µL, (H2O) 250 µL N
4 R2ARM (R3) 20 µL, (R2) 20 µL(, H2O) 50 µL Y
Method Specifics 0

• Type ‘b method.
• Results with absorbance flag may be resolved by replacing source lamp.
• 24 hour urine collection: Commonly used urine preservative is 6 mmol/L HCL. The pre-
servative volume per collection is determined by each laboratory..
• Dimension® RxL / RxL Max non- HM Module: (see AUD for additional details) .
• Dimension® RxL / RxL Max/EXL/EXL with HM Module: (see AUD for additional
details) .
dilution is performed using 100 µL Sample Syrnge for sample aspiration and 2500µL
ple to the cuvette.
• .Dimension® Xpand® and Xpand® Plus clinical chemistry system: (see AUD for
additional details)
ric Cuvette. PUD (Photometric Urine Dilutions). The dilutions are performed using
100µL Sample Syringe for sample aspiration and 500µL R1 Metering Syringe for the
dilution. The Photometric Sampler transfers the diluted sample from the first cuvette to
the second cuvette.

302 P Methods
Troubleshooting 0
• Small sample size - susceptible to sample fluidics.

• Intermittent low outliers can be caused by a leaky sample tubing.
• Negative or “0” results and repeats of same sample give a reasonable result and are
caused by wicking. Can see low results by wicking from URCA, high results by wicking
from CA and TGL. Check film heights and that a good U-seal is being made. Negative
results can also be caused by film pulling out from window..
• High outliers (15-18 mg/dL) can happen because there is not enough reagent in well 7
(common well for whole cartridge). They can also be caused by a bad reagent probe tip
or R2 probe to Flex® cartridge alignment.
• High outliers can be caused by phosphate carryover from reagents containing phos-
phates or phosphate buffers (ALP, THEO and other drugs). Check R2 tubing. Look for
prior reagent in filterdata.
• CRP and THEO interfere with PHOS - use "optimized time to results" feature.
- CRP,PHOS
- PCHE,PHOS
- PTN,PHOS
- THEO,PHOS
Result Monitor
Tab. 84 Limit Table
Rslt Mntr Optical Fil- Minimum Maxi- Above Below Error Mes- Status
ters Reps mum Mean Fac- Mean Fac- sage
Reps tor tor
B 510/540 10 250 0.0 0.0 abnl assay not active

P Methods 303

PHOS A on sample and reagents . Checks molybdate delivery by R2ARM.
Endpoint at (r3) air blanked. 20 µL of R2: molybdate from well 8.
Bichromatic at reagent max (293/700)
Mean 1000mA ± 40 τψπιχαλ
Limits are mean + 20% ορ −25%
B icterus flag. Default limits are set to zero.
Result Monitor B uses the 510/540 nm fil- For more information, review CSB D-0326,
ters to detect spectral interference from dated July 21, 2003.
bilirubins. To activate the limit, contact UPS.

304 P Methods
PROC 15.6
Method Chemistry 0

1 R1ARM (R2) 80 µL, (R1) 130 µL (H2O) 103 µL N
2 SAMPLE 2µL, (H2O) 33 µL Y
5 R2ARM (R3) 80 µL, (H2O) 40 µL Y
6 PHOT READ hard read 340/700 nm -
7 PHOT READ hard read 340/700 nm -
Method Specifics 0

• PROC uses a logit method for calibration. All terms will change with calibration, except
the C4; C4 is 0.5.
• Put up: 20 tests per reagent cartridge.
• Whole blood treated with EDTA, sodium heparin, lithium heparin, can be used for this
assay.
• Specimens should be collected by normal procedures.
Troubleshooting 0
• Make sure that reagent has not been frozen by the instrument or the refrigerator, since
it may alter particle reagent and can cause gross imprecision.

P Methods 305

This flag represents final absorbance at 340 nm for the last read. It is used to check for the
final absorbance reading. This flag ensures that the absorbance values used to calculate
analyte units did not exceed the photometer detection limits (final optical density or FOD)
of the analyzer.
Troubleshooting
This error occurs if there is non-specific atypical aggregation due to abnormal proteins or
grossly turbid or lipemic samples.
if (fod>1700)
FOD_ERROR

This flag monitors the particle reagent to ensure that an aggregation reaction has not
already occurred before the test measurement occurs. This measurement is similar to that
of Result Monitor A. However, the measurement has not been corrected for background
mAU (i.e. has not had absorbance at 700 nm subtracted).
if (monoPR>1700)
IOD_ERROR;
Troubleshooting
Check for particle reagent that may have aggregated possibly due to freezing in the refrig-
erator or reagent tray.

It checks to make sure the particles were added and can sometimes tell if the particles
aggregated in the Flex® on it's own. It checks that the particles were delivered and not
short sampled. This flag monitors the identical phenomenon as Result Monitor A.
if (part1<150)
IOD_ERROR;
Troubleshooting
Imprecision of pipetting both buffer and particle reagent. This may be caused by particle
reagent delivery problems by R1 reagent arm or gross fluidic problem from a clogged
probe, crimped reagent tubing, leaking or loose fitting on pump valves or bad R1 syringe
tips.

306 P Methods

This flag checks for aggregation when particles and sample are present (No antibody is yet
added at this point). It's a check to make sure that NOTHING in the sample causes non-
specific (Nonsp) aggregation of the particles. No change in values should occur until the
antibody is added. If there is a change greater than the limits, the result gets flagged for
non-specific aggregation.
This flag monitors the identical phenomenon as Results Monitor B.
if (nonsp > 60 || nonsp < -20)
FOAM_ERROR;
Troubleshooting
• Check for non-specific aggregation prior to the addition of the antibody reagent.
• Sample quality issues such as fibrin strands, small fibrin clot is added to the cuvette.

Limit is 100 mau. It checks for foaming, non-specific particle aggregation, excess turbidity
prior to antibody addition. Checks for foaming, air bubbles, turbidity, or scatter in the
cuvette.
if (check700>100)
FOAM_ERROR;
Troubleshooting

Assay Range
Errors will be printed if the sample concentration is below or above the assay range.
Troubleshooting
Assay Range (results below assay range)

P Methods 307
• If the calculated sample concentration confirms the concentration to be < 0.5 mg/mL,
the result should be reported as “less than 0.5 mg/mL”.
Assay Range (results above assay range)
tion factor or 2.
NOTE Autodilute feature is not available for the PROC method.
Below Assay Range

Errors will be printed (without the numerical value) if the sample concentration is below the
calculation range.
Troubleshooting
Concentrations below assay range:
Above Assay Range

Errors will be printed if the sample concentration is above the calculation range.
Troubleshooting
Concentrations above assay range.
tion factor or 2.
NOTE Autodilute feature is not available for the PROC and method.
Possible Causes
• Flex® reagent cartridge exposed to freezing conditions.

308 P Methods
Possible Causes
Result Monitor
NOTE “abnormal reaction” report message has higher priority over

“abnormal assay”. Only the highest priority message will
appear on the printout even though there may be more mes-
Tab. 85 Limit Table
Rslt Mntr Optical Fil- Minimum Maximum Above Mean Below Mean Error Mes- Status
ters Reps Reps Factor Factor sage
B 340 50 250 1.5 0.5 abnl assay active

P Methods 309

PROC Reagent QC - 1 calculation: end-point • Precision of pipetting both buffer and particle rea
(r1), air blanked, bi-chromatic (340/700) • Not enough particle reagent delivered by R1 reag
Limits: Mean ± 50% or gross fluidic problem from a clogged probe, c
This monitors the particle blank for reagent tubing, leaking or loose fitting on pump v
each test. The particle blank absor- bad R1 syringe tips.
bance is taken after the addition of par- • Insufficient volume of either particle or buffer in w
ticle and assay buffer and sample. This would trigger this flag.
measurement has also been corrected
for by any background mAU (any absor- • Particles which may have agglutinated in the Fle
bance at 700 nm has been subtracted). ωουλδ (ι.ε. φροζεν Φλεξ®).
• If a single patient sample is flagged with abnorma
error, analyze sample by an alternate method si
possible there is an interfering substance presen
sample.
Reagent QC - 2 calculation: rate (r2-r1), Unstable particles would trigger the flag. Patient sam
non-air blanked, monochromatic (340) with specific interference which have not been identif
Limits: Mean ± 50% possibly trigger an agglutination reaction and would
tified by this flag. If a single patient sample is flagge
This monitors non-specific agglutina- abnormal assay error, analyze sample by an alterna
tion reactions which may occur (in method since it is possible there is an interfering sub
absence of antibody). Prior to antibody present in the sample.
reaction, the mAU should have negligi-
ble increases over time.
Abnormal Assay A (Result Monitor A)

This monitors the particle blank for each test. The particle blank absorbance is taken after
the addition of particle and assay buffer and sample. This measurement has also been cor-
rected for by any background mAU (any absorbance at 700 nm has been subtracted).
Troubleshooting
• Precision of pipetting both buffer and particle reagents.
• Not enough particle reagent delivered by R1 reagent arm or gross fluidic problem from
a clogged probe, crimped reagent tubing, leaking or loose fitting on pump valves or bad
R1 syringe tips.
• Insufficient volume of either particle or buffer in well would trigger this flag.
• Particles which may have agglutinated in the Flex® would (i.e. frozen Flex®).
Abnormal Assay B (Result Monitor B)

This monitors non-specific agglutination reactions which may occur (in absence of anti-
body). Prior to antibody reaction, the mAU should have negligible increases over time.

310 P Methods
Troubleshooting
• Unstable particles would trigger the flag.
• Patient samples with specific interference which have not been identified may possibly
trigger an agglutination reaction and would be identified by this flag.
NOTE If a single patient sample is flagged with abnormal assay


P Methods 311
PTN 15.7
Method Chemistry 0

3 PHOT READ 340/700 -
4 R2ARM (R3) 40 µL, (H2O) 25 µL Y
5 PHOT READ double hard read 340/700 -
Method Specifics 0

• Type ‘b method.
• Turbidimetric – uses inner detection cell only.
• As with all PETINIA methods, PTN is a nonlinear method with five C terms. All terms will
change with calibration, except the C4; C4 is 0.5.
since this may alter the Particle Reagent. Increases in temperature may also affect the
Particle Reagent.
Troubleshooting 0
• If source lamp is replaced, recalibrate.
insert. If Arithmetic Error is generated on recalibration, calculate and accept the new
curve if acceptable calibration guidelines are met. Check QC.

312 P Methods
Error Messages
Abnormal Reaction
• Occurs if check700 (>100mA) due to FOAM ERROR.
• If not patient-specific, check photometrics, sample probe/ultrasonics and R1 probe, in
that order. For patient-specific flags, analyze by an alternate method or contact GPS for
assistance.
Result Monitor
Tab. 87 Limit Table
Rslt Mntr Optical Filters Minimum Reps Maximum Above Mean Below Mean Error Mes
Reps Factor
A 340/700 28 250 +7 SD -7 SD abnl assay

PTN A on sample and reagents. Particle Reagent (R2) delivery by
Endpoint (r1), air blanked. R1ARM.
Bichromatic (340/700). Check Wells 4-6, all reagents liquid.
Photometric read (r1) on cuvette.

Mean 700 mA ± 10 τψπιχαλ.
Limits are mean ± 7 Σ∆σ.
Abnormal Assay
• Occurs if Result Monitor side A is “hi” or “lo”. Result Monitor A monitors consistent
reagent delivery.
• Check R1 probe, alignment and tubing.

R Methods 313
16-
RCRP
16R Methods
Method Chemistry 0
First Cuvette [Ag excess detection/assay range curve (AR)]

Second Cuvette [sensitivity curve (SR)]

Method Specifics 0
• Turbidimetric, bichromatic 340/700 nm.

• Two cuvette/dual PETIA method uses cuvette to cuvette transfer.
• Calibration curve logit, combo curve.
• Trip point is level 3, which is 4.00 mg/dL [40 mg/L].
• AR = first cuvette, assy range or rate.

314 R Methods
• SR = second cuvette, sensitivity rate.
Troubleshooting 0
• Check Flex® reagent cartridge for presence of reagents. Check if Ab-Pr reagents are
frozen and clumped.
• Check R1 probe for alignment, vacuum tip, ultrasonics.
Result Monitor
Tab. 88 Limit Table

A 340/700 30 250 1.2 0.8 abnl Active
assay
B 340/700 30 250 1.2 0.8 abnl Active
assay

RCRP A Cuvette 1 reagent blank (168 µL buffer, Check (R1) buffer and (R2) Ab-PR
80 µL Ab-PR reagent, 132 µL H2O). delivery by R1ARM to first cuvette.
Cuvette 1 read 1 (340-700) corrected for Mean difference between cuvettes 1
air blank. and 2 should be less than 18%. If
Limits Mean +20% or –20% higher, abnormal reaction error will
Mean limit 300-1000 indicate inadequate delivery of Ab-PR
reagent.
Check Flex® cartridge for presence of
reagents, check if frozen Ab-PR
reagents are clumped.
Check R1 probe for alignment, vac-
uum, tip, ultrasonics.
B Cuvette 2 reagent blank (168 µL buffer, Check (R1) buffer and (R2) Ab-PR
80 µL Ab-PR reagent, 132 µL H2O). delivery by R1ARM to second cuvette.
Cuvette 2 read 1 (340-700) corrected for
air blank.
Limits Mean +20% or –20%
Mean limit 300-1000

S Methods 315
17-
SAL
17S Methods
Method Chemistry 0

2 SAMPLE 15 µL, (H2O) 10µL Y
4 R2ARM (R3) 50 µL, (H2O) 10µL Y
Method Specifics 0

• Sensitive to sample ultrasonics maintenance.
• Results <2.8 mg/dL should be considered negative due to serum blank.
• Uses aqueous secondary calibrator.
• Positive bias is obtained on samples spiked with sodium azide (QC and proficiency sur-
vey samples).

316 S Methods
SIRO 17.1
Method Chemistry 0
Tab. 89

1 R2ARM (R3: Lys Rgt) 70 µL N
4 R2ARM (R2: CrO2) 0 µL, remix R2 Y

Total Cuvette Volume: 395 µΛ
Method Specifics 0
• SIRO is processed on Dimension® RxL/Xpand/EXL® with HM only.

S Methods 317
• ACMIA assay format, CPRG detection

• Type ‘c’ method (requires pre-processing in HM module)
Sample Integrity
• Run in “Limited Cup, No Level Sense” or “SSC” mode and “CSF/Blood” as Fluid type.
SIRO will not process in primary tubes.
• To ensure optimum mixing and sample transfer, pipette 200 µL of sample into cup or
SSC; pipette 300 µL of sample to request calibration or 5-test precision testing.
• Too much sample in the cup may cause poor remix during ultrasonics and/or may
cause sample splatter.
• Lysing of red blood cells is accomplished by mixing in the presence of lysing reagent.
• Specimen should be sampled within 30 minutes of placement on instrument. Suggest
running tests as STAT.
• SIRO includes the “Zero Limit” feature. Analyte results calculated between 0 and –2.5
ng/mL will be reported as “0” on the report printout.
• Calibrators must be warmed to room temperature before use. Suggest minimum 30
minutes at room temperature prior to use (after overnight thaw at 2-8 C).
• QC should be consistently handled following manufacturers recommendations. Ensure
thorough mixing prior to transfer to sample cup/SSC.
Instrument Checks
• Check all alignments on the instrument, especially the alignments of R2 and Sampler to
HM wheel.
• R2 arm is used extensively with this method.
• R2 probe alignment to HM wheel (horizontal alignment) is very important to perfor-
mance. Misalignment by more than 5 steps can cause splashing of conjugate or
chrome which can be noted by visual inspection during method processing with the
instrument cover up. Ensure that all alignments are stable. Vertical alignment of R2 to
HM target should be set 3-5 steps above probe tight against paper.
• Sample probe alignment to HM wheel (vertical alignment too high) can result in low out-
liers since during transfer of vessel supernatant, sample probe dives just below the
meniscus of HM vessel to avoid disturbing the magnetic particles along the sides of the
vessel.
SIRO Reagents
• Well 1, 2: conjugate reagent
• Well 3, 4: 4 chrome tablets hydrated with 1900 µL of chrome diluent
• Well 5, 6: 2 CPRG tablets hydrated with 1400 µL of CPRG diluent & 400 µL H2O
• Well 7: CPRG Diluent

318 S Methods
• Well 8: Lysing reagent (2.8 mL)
Troubleshooting 0
Abnormal Reaction
The fixed foam error limit (rgt2blank <35 or >200 indicates FOAM or CrO2 in cuvette or low
CPRG reagent in cuvette.
Result Monitor

The SIRO method uses two result monitoring errors: RM A and RM B.
sion software. The limits, however, are tighter than the fixed foam error limit described
chrome carryover or check the functionality of the magnet.
• RM B is based on a 30 second hard read at 700 nm. If the Result Monitor B limits are not
met, an “abnormal assay” error is generated. If RM B mAUs are <35, an “abnormal
reaction” error is generated.
Tab. 90 Limit Table

A 577/700 10 250 1.2 0.8 abnl Active
assay
B 700 10 250 2.0 0.4 abnl Active
assay
Cross Reactivity
• SIRO antibody has 102% cross reactivity with Everolimus (Certican®). This drug is
structurally similar to sirolimus but is not currently available in the US. It is a commonly
used immunosuppressive drug outside the US and may be a cause of apparent siroli-
mus levels in a patient who is not taking sirolimus. If such a situation is reported, inquire
whether the patient in question is taking everolimus. We cannot support the use of the
SIRO method for quantitation of everolimus levels.
• Carryover pair: TAC,SIRO

T Methods 319
18-
T4
18T Methods
Method Chemistry 0

1 R1ARM (R1) 20 µL, (H2O) 40 µL N
2 SAMPLE (S) 16 µL, (H2O) 34 µL Y
4 R2ARM (R5) 50 µL, (H2O) 40 µL Y
5 R2ARM (R5) 50 µL, (H2O) 40 µL Y
Method Specifics 0

• Flex® type = 8 well; all liquid reagents.
• T4 method does extra reagent probe washes before entering the cuvette.
• T4 is a triple-dip method.
• The assay range for the Dimension T4 method is from 0.5 to 24 µL/dL. The FT4 method
reports to 1 decimal places. Samples with results in excess of 24 µL/dL should be
diluted with reagent grade water to obtain a result within the assay range. Samples with
results less than 0.5 µL/dL should be reported as “less than 0.5 µL/dL”.
• Pump backlash can be a problem.
• Sample is delivered at 1 mm, very low in the cuvette.
Method Troubleshooting 0
Accuracy
• T4 is very temperature sensitive. 1.0°C = 1.0 units change in T4.
• Calibration is sensitive to calibrator hydration. Follow the procedure in the calibrator
insert sheet carefully.

320 T Methods
• Troubleshoot QC shifts by running a new QC Flex®. Common wells may be contami-

nated and opening a new well in the same Flex® may not help.
• When calibrating the T4 method, the uncalculated calibrator results may have arith-
metic errors. Press calculate and review the calibration statistics and QC.
• T4 is very sensitive to photometer positioning. Make sure that the thermal chamber
insulation and photometer cables are not interfering with the photometer. Lube the pho-
tometer bearing.
• Well-to-well shift.
- Reagent hydration problems will cause accuracy problems if a poorly hydrated well is
used to calibrate a reagent lot.
- Incomplete tablet dissolving: prehydrate a well for 30 to 60 minutes.
- Floating tablets during reagent hydration: align reagent probe.
- Diluting R3 in well 5 or 6 (R3) can affect the accuracy of the T4 result. Diluting of R3
may happen because R3 is in the middle of a triple dip and will be diluted if some R4
drips into R3. R4 is the first reagent aspirated in the triple dip. Look for worn R2
reagent probe tip, a leak in the tubing, buildup in the reagent tubing, or poor vacuum.
- Reagent stability can be a problem for R1 and R2 in wells 7 and 8.
- Source lamp change shifted T4 QC lower.
Precision
• To test the precision, run a 15-test precision run. Calculate SD and CV for three 5-test
groups (1-5, 6-10, 11-15). Refer to insert for precision guidelines. Running 15 tests will
cause the instrument to use reagent from two wells, 10 from the first and 5 from the sec-
ond.
If each of the 5 test groups is outside the stated specifications, troubleshoot the reagent
side of the instrument. Replace the R2 probe tip, check alignments, and change R2 tub-
ing. If not fixed, replace the R2 500 µL syringe tip.
If the five test groups are within acceptable performance, but there is a definite accu-
racy shift between the second and third group, troubleshoot the reagent prep area (R2)
of the instrument. Replace the R2 2500 µL syringe tip. If not fixed, replace R2 ultrason-
ics.
• Imprecision at the ends of the assay range:
- The ends of the curve of the EMIT methods tend to level off, causing results from the
ends of the curve to have poorer precision than results from the middle of the curve.
As the curve becomes flat at low and high concentrations of analyte, there is a
smaller change in absorbance for each unit change in analyte. To prove that the
imprecision is a method problem and not an instrument problem, view the results in
MAU.
- In the Method Review screen, call up the patient specimen in question. Press the F7
function key to toggle the function to Show MAU. Toggle between the result and MAU
values for each patient. Not the larger change in MAU per Unit change for specimens
within the Reference Range as compared to the smaller change in MAU per Unit
change.

T Methods 321
TACR 18.1
Method Chemistry 0

1 R2ARM (R3: Lys Rgt) 70 µL N
3 R2ARM remix (R1: conjugate) 50 µL, (H2O) 40 µL Y
4 R2ARM (R2: CrO2) 0 µL, remix R2 Y

1 R1ARM (R4:CPRG) 150 µL, (H2O) 155 µL N
Method Specifics 0
• TACR is processed on Dimension® RxL/Xpand/EXL® with HM only.

• R1 conjugate is remixed prior to aspiration using software 10.0.5 MR1 or greater.
• Type ‘c’ method (requires pre-processing in HM module)
• ACMIA assay format, CPRG detection

322 T Methods
Sample Integrity
• Run in “Limited Cup, No Level Sense” or “SSC” mode and “CSF/Blood” as Fluid type.
TACR will not process in primary tubes.
• To ensure optimum mixing and sample transfer, pipette 200 µL of sample into cup or
SSC; pipette 300 µL of calibrator to request calibration or 5-test precision testing.
• Too much sample in the cup may cause poor remix during ultrasonics and/or may
cause sample splatter. Too little sample may result in foaming in the sample container.
• Lysing of red blood cells is accomplished by mixing in the presence of lysing reagent.
• Specimen should be sampled within 30 minutes of placement on instrument. Suggest
running tests as STAT.
Instrument Checks
• Check all alignments on the instrument, especially the alignments of R2 and Sampler to
HM wheel.
• R2 arm is used extensively with this method.
• R2 probe alignment to HM wheel (horizontal alignment) is critical to performance. Mis-
alignment by more than 3 steps can cause splashing of conjugate or chrome which can
be noted by visual inspection during method processing with the instrument cover up.
Ensure that all alignments are stable. Vertical alignment of R2 to HM target should be
set 3-5 steps above probe tight against paper.
• Sample probe alignment to HM wheel (vertical alignment too high) can result in low out-
liers since during transfer of vessel supernatant, sample probe dives just below the
meniscus of HM vessel to avoid disturbing the magnetic particles along the sides of the
vessel.
TACR Reagents
• Well 1, 2: conjugate reagent
• Well 3, 4: 4 chrome tablets hydrated with 1900 µL of chrome diluent
• Well 5, 6: 2 CPRG tablets hydrated with 1400 µL of CPRG diluent & 400 µL H2O
• Well 7: CPRG Diluent
• Well 8: Lysing reagent (2.8 mL)
Troubleshooting 0
Abnormal Reaction
The fixed foam error limit (rgt2blank <35 or >200 indicates FOAM or CrO2 in cuvette or low
CPRG reagent in cuvette.

T Methods 323
Result Monitor
Tab. 91 Limit Table

A 577/700 10 250 1.2 0.8 abnl Active
assay
B 700 10 250 2.0 0.4 abnl Active
assay
Abnormal Assay
The TACR method uses two result monitoring errors: RM A and RM B.
in detecting problems related to CPRG tablet hydration or delivery. Investigate R2
hydration fluidics and mix or R1 fluidics transfer.
sion software. The limits, however, are tighter than the fixed foam error limit described
chrome carryover or check the functionality of the magnet.
• RM B is based on a 30 second hard read at 700 nm. If the Result Monitor B limits are not
met, an “abnormal assay” error is generated. If RM B mAUs are <35, an “abnormal
reaction” error is generated.
TACR Accuracy and Precision Troubleshooting
NOTE This assay does not use the HM wash probes so there is no
need to perform typical HM troubleshooting.
Reagent Arm Maintenance

• Ensure that R1 and R2 probe tips are tightened and aligned properly.
• Alignments of R2 probe to Flex and HM wheel are critical and should be checked rou-
tinely (monthly). Ensure that alignments to HM wheel are stable by checking several
times before storing the alignment settings.
• Weak R2 ultrasonics may lead to poor reagent remix and incomplete tablet dissolution.
• Examine reagent tubing, it must be tightly connected. Replace if there are any cracks or
leaks.
• Reagent drains should be cleaned periodically. Check that vacuum is within specifica-
tions.

324 T Methods
Sample Arm Maintenance

• Ensure that sample probe tip is tightened and aligned properly.
• Sampler ultrasonics performance is important with WB methods. Too strong of a mix
may cause foaming in the sample cup.
• Alignment of sample probe to sample drain, sample cup and HM wheel are critical and
should be checked routinely. This includes both vertical and horizontal alignment.
• Ensure the sample drain is clean and that H2O and probe cleaner are not restricted.
More frequent cleaning of sample drain is recommended when a high volume of whole
blood samples are analyzed.
Pump Panel
• Inspect the area around the pump panel and make sure there are no visible signs of
leaks such as dried crystal like material.
• TACR is subject to sample fluidics due to the large sample size transferred from the
vessel to the cuvette. Inspect the sample syringes for any signs of leaks/air bubbles or
damage.
Photometer
• Clean all cuvette windows. Dirty windows may increase imprecision.
• Assess photometer and source lamp function using PXQC.
Sample Handling
• Calibrators, quality control materials and patient samples should all be equilibrated to
room temperature (18-25°C) before use.
• Mix all samples gently but thoroughly just before use. Mix by hand or on an inverter or
rocker. DO NOT VORTEX as this may cause foaming.
• Transfer 200 µL to a sample cup for processing on the Dimension® system. Samples
should not be allowed to sit on the instrument for more than 30 minutes prior to sam-
pling.
• Do not process primary tubes directly on the Dimension® for this method.
Technical Tips
Linearity
• TACR calibrator Level recovery is near 40 ng/mL
- May dilute high level calibrator to improve linearity recovery or perform precision.
- Dilute 4 parts Level 5 calibrator to improve linearity recovery or perform precision
- Calculate [(Level 5*4)/5] + [(Level 1*1)/5]
- Example using bottle values from lot 3DD040: [(40.4*4)/5] + (0.3/5) = 32.38

T Methods 325
TBI 18.2
Method Chemistry 0

1 R1ARM (R1) 250 µL, (H2O) 25 µL N
3 PHOT READ hard read 540/ 700 nm
Method Specifics 0

• Type “b” method.
• Calibrator type: Linear.
• Level 1 calibrator is not supplied. Customer supplies clinical laboratory reagent water.
• Required to use TBI/DBI calibrator, catalog number DC167.
• TBI/DBI calibrator (DC167) is traceable to NIST SRM 916.
• Standard sample volume is 10 µL. There is no reduced sample volume.
• Auto-dilute volume is 5 µL.
• TBI measures total bilirubin, direct-acting bilirubins, monoconjugated (β), diconjugated
bilirubin (γ), delta bilirubin (δ), and unconjugated bilirubin(α).
• Delta fraction is irreversibly bound to albumin, is clearly distinct from albumin-unconju-
gated bilirubin (α) complex, and is the slowest reacting fraction in the total bilirubin reac-
tion.
• Customers should not use the TBIL/TBI and DBIL/DBI methods interchangeably.
• Calculated Results: Indirect Bilirubin (IBIL) = TBI - DBI (Direct Bilirubin)
• There is no result monitor for the TBI method. This field in the methpar is used for the
“crit” calculation of the hemoglobin flag.
• TBI results are automatically corrected up to 1000 mg/dL of hemoglobin.
• TBI method requires software version 7.4 or higher.

326 T Methods
Troubleshooting 0
• Delta bilirubin is present in a variety of patients with hyperbilirubinemia and hepatobil-

iary disease (such as liver cancer and severe obstructive jaundice)..
• Measurement of delta bilirubin (δ) with the TBI method is improved over the perfor-
mance with TBIL. If the DBI result is > TBI result, suspect delta bilirubin may be present.
Try diluting the sample and retesting the DBI and TBI. By doing this, the ratio of δ biliru-
bin to reagent is lowered to optimize reaction.
• Delta Bilirubin is a direct reacting fraction of bilirubin (albumin-bound) present in a vari-
ety of patients with hyperbilirubinemia and hepatobiliary disease.
• Delta bilirubin is not found in healthy population or in patients with unconjugated hyper-
bilirubinemia, including Gilbert’s disease, neonates and patients with hemolysis. It’s
absence in neonates with physiologic jaundice and Gilbert’s disease suggests that the
ability to glucoronate bilirubin is essential for the formation of albumin-bound bilirubin.
• The large amount of delta bilirubin in patients with a wide variety of hepatobiliary dis-
eases suggests that impaired bilirubin excretions in addition to intact conjugating mech-
anism is essential for delta bilirubin to appear.
• Delta bilirubin may result from tight albumin binding of bilirubin photoisomers which
could accumulate along with bilirubin conjugates during cholestasis.
• Delta bilirubin is the slowest reacting bilirubin fraction in the total reaction.
• Delta bilirubin occurs widely in adult icteric sera especially elevated during sever
obstructive jaundice.
• In patients with clinical worsening and increasing total bilirubin, delta bilirubin ranged
from approximately 20-50% of the total bilirubin. Delta bilirubin constituted a higher per-
centage of total bilirubin (50-90%) during clinical improvement with decreasing total
bilirubin.
• A ‘hemoglobin’ error message indicates the hemoglobin concentration in the sample is
greater than 1000 mg/dL and will depress the TBI result. TBI results flagged with a
‘hemoglobin’ message should not be reported. TBI results for samples with hemoglo-
bin up to 1000 mg/dL will be corrected for the hemoglobin interference.
• Sensitive to reagent temperature. Calibrate reagent temperature when troubleshoot-
ing accuracy issues.
• Carryover pairs: TP/TBI, UCFP/TBI
Measurement Error 0
MEAS_ERROR may be generated on all patients and not QC. This happens if DBI calibra-
tion steps are not followed as described in the Operators Guide. Calibration must be
accepted to store “cal-base” which is required for patient calculations. Failure to use “fresh”
clinical laboratory reagent water such as purified water diluent may cause this error. If
MEAS_ERROR is obtained, repeat DBI calibration, ACCEPT and STORE the calculated
coefficients.

T Methods 327
High Intercept After Calibration 0
The calibration slope should be should be 0.97 to 1.03 and the intercept should be not clin-
ically significant. The DBI calibration automatically adjusts the Level 1 to “zero”. The calcu-
lated intercept may appear to be higher than expected. Assess the recovery of the
calibrators for accuracy.
Open Well Stability 0
Identifying Open Well Instability

See the Flex® map below. Working diazotized sulfanilic acid (the diazo reagent) is prepared
in well 2 by adding NaNO2 from well 3. The prepared reagent is stable for 15 days. The QC
should recover within 2SD. If QC is drifting outside of +2SD may be contributed by instabil-
ity of the diazo reagent. Obtain X-link filterdata as evidence to support this issue. R2ARM
maintenance is recommended to resolve instability of the diazo reagent.
Fig. 23: TBI
Resolving Open Well Instability
1. Process sample(s) or QC using freshly a hydrated well set (go to a new well set).
2. If this brings QC recovery to expected values compared to the old well set, this indi-
cates reagent instability. Perform the following corrective maintenance procedures:
- Clean R2 drain (and R3 drain if RMS is present).
- Check R2 probe (and R3 probe if RMS is present) for tightness and correct align-
ment.
- Replace R2 reagenet tubing (and R3 reagent tubing if RMS is present).
- Replace R2/R3 drain tubing to the waste tubing harness.
- Replace waste tubing harness to the vacuum bottle.
- Dispatch a service engineer to replace the vacuum pump and R2/R3 drain.
- Check X-Link filter data prior to doing maintenance and after maintenance to monitor
the success of the maintenance performed.

328 T Methods
TGL 18.3
Method Chemistry 0

1 R1ARM (R1) 133 µL, (H2O) 217 µL N
Method Specifics 0
• Endpoint, bichromatic 510/700 nm with volume correction.

• Type “a” method.
• Flex® type = 6 well; single reagent (liquid-3.33 mL per well)
• Auto-dilute volume = 2 µL.
• An “Abnormal Assay” error may appear if the TGL Reagent (blank) exceeds 250 mA.
• The TGL assay range (15-1000 mg/dL) is not covered by the calibration range (typical
level 3 upper calibrator is 485 mg/dL). The assay range may be set to 485 mg/dL to be
consistent with the highest TGL calibrator. TGL values greater than 485 mg/dL will be
automatically diluted.
• The assay range (15-1000 mg/dL) can be verified using mixtures of patient samples
containing high and low triglycerides-based standards may be used. (See TGL FAQs
on internal data obtained for Assay/Reportable Range Verification).
• DO NOT USE commercially available glycerol-based standards to verify TGL assay,
linearity or reportable range.
Troubleshooting 0
• The Abnormal Assay flag indicates inaccurate delivery of the TGL reagent. Potential
causes of inaccurate delivery include:
- Condition of the R1 reagent probe tip.
- Alignment of the R1 reagent arm.
- Condition of the R1 syringe tip.
- Gap on the R1 syringe
- Crimping of the R1 tubing

T Methods 329
• Imprecision and inaccuracy

- Dirty windows and clogged tubing on the sample and reagent probes would most
likely affect precision and accuracy of TGL results.
• TGL reagent may precipitate over time since it is a very concentrated solution. Thus,
the reagent is mixed prior to every removal from the Flex® at each draw. The accuracy
of the TGL results is not adversely affected since the result is reagent blank corrected.
• Within well “rgtbl” imprecision caused by lack of pre-mix is resolved by replacing R1
transducer.
• Low reagent delivery by R1 arm may give “abnl assay” errors.
• Improper storage exposing reagent to higher temperature (improper shipping, defec-
tive refrigerator, etc.) will cuase reagent blank (rgtbl) to shift higher, causing “abnl
assay” errors. Results are producible. Investigate and explain to end user about proper
storage temperature.
• Low patient and QC results (accuracy shift low) on aging wells may be caused by
R1ARM and R1 drain. Enzymes in the reagent are deactivated by contaminant, caus-
ing low results.
- Clean R1 drain and vacuum tubing thoroughly
- Check R1 probe tip for wear.
- Check R1 tubing and tighten loose fittings/connections
- Perform R1 pump maintenance.
- Replace defective R1 pump valves.
- Replace R1 syringes.
• Carrover pairs: CKI, TGL
How to Resolve TGL Open Well Instability

Nature of the Problem
Normally, QC is within 2 SD range on fresh wells. As an open well ages, within approxi-
mately 8 to 24 hours the QC drops lower by 30 to 50%. The open well stability is reduced
to 8 to 24 hours from 10 days. If QC is run on a fresh well, QC is in range. This is a classic
open-well stability issue.
Cause
TGL reagent is sensitive to contamination. The open-well instability results from well con-
tamination associated with any of the following:
• R1 probe tip worn.
• R1 drains dirty with protein buildup
• Reagent tray lid may be rubbing the rotating reagent cartridges and contaminating the
TGL well.
Resolution

330 T Methods
1. Check reagent tray lid underside.

- Look for reagent buildup on the lid; if yes, reagent tray is rubbing on the lid.
- Remove shims from underside of reagent tray to lower the tray.
- Typical clearance is 0.030 to 0.040 inches so tray will not rub on the tub liner.
2. Bleach the R1 drain.
What causes black precipitate in TGL well?
TGL reagent may precipitate over time since it is a very concentrated solution. The normal
color is brownish to brown liquid. Formation of fine particles is normal. The reagent is
always remixed by R1 ARM before R1 addition.
Result Monitor
Tab. 92 Limit Table

A 510/700 50 250 1.5 0.8 abnl Active
assay

TGL A Reagent Blank - mau2 Check (R1) enzyme reagent delivery
End-point at (r2), air blanked by R1ARM.
Bichromatic (510/700) An “abnormal assay” error may

appear if the TGL Reagent (blank)
Reagent blank = mau2 exceeds 250 mA. The “abnormal
Limits: Mean + 50% or -20% assay” error indicates inaccurate
delivery of the TGL reagent. Poten-
tial causes of inaccurate delivery
include:
• Condition of the R1 reagent
probe tip
• Alignment of the R1 reagent arm
• Condition of the R1 syringe tip
• Gap on the R1 syringe
• Crimping of the R1 tubing

T Methods 331
THC 18.4
Method Chemistry 0

1 R1ARM (R1) 245 µL N
3 R2ARM (R2) 105 µL, (H2O) 20 µL Y
Method Specifics 0
• Urine Cannabinoid, qualified for urine only.

(mean of N=5).
Troubleshooting 0
Error Messages
Absorbance

332 T Methods

method.
Low ‘A’ Error

• Root Cause:
High ‘A’ Error

Abnormal Reaction
• Root Cause:
Inaccuracy
sheet.
• Does not detect synthetic THC’s.

T Methods 333
Imprecision
• R1 probe.

334 T Methods
THEO 18.5
Method Chemistry 0

5 R2ARM (R3) 40 µL, (H2O) 25 µL Y
6 PHOT READ Double hardread 340/ 700 nm
Method Specifics 0

• Non-linear method with C4 term of 0.5.
Troubleshooting 0
• Accuracy problems are few. Method is very stable and QC ranges hold steady. This is a
turbidimetric method with good separation between Level 1 and Level 5 calibrator, giv-
ing good precision to the method. Troubleshoot the accuracy shifts by replacing the
source lamp. If source lamp has just been replaced, recalibrate.
• Changing either the Flex® lot or calibrator lot may cause some QC shifts at the high
end. Do a patient crossover to see if the shift is significant. Also try recalibrating. You
may see “Failure to converge” after calibration, but ignore this message.
• Precision - Make sure that the reagent has not been frozen by either instrument or the
refrigerator. Particles will precipitate out.

T Methods 335
• Detergent in reagent #1 can be susceptible to foaming but with this revision would be a
rare occurrence. Does give “Abnormal Reaction” errors. Check filterdata to determine
cause - typically Part Blnk < 350 is seen as cause due to inadequate particle reagent
delivery. Troubleshoot these errors as follows. Check R1 fluidics for proper delivery. If
not resolved:
- Change source lamp.
- Check 340/700 filters for any delamination.
- If source lamp is replaced, recalibrate.

336 T Methods
TNI 18.6
Method Chemistry 0

1 -603.4 sec Sample (Sample) 20 µL / (H2O) 10 µL N
2 -590.8 sec R2ARM R2 (Chemibead-Ab) 20 µL N
R2ARM R1 (Biotinylated-Ab) 20 µL
3 -151.8 sec R2ARM R3 (Sensibead) 13 µL / (H2O) 10 µL N
4 -58.3 sec R2ARM R4 (Assay Buffer) 100 µL / (H2O) 57 µL N
5 0 sec LOCI ARM LOCI read vessel (4 assay read cycles) N
Method Specifics 0
• LOCI method, a homogeneous, sandwich chemilumiscent assays.

• TNI method is only available on the Dimension eXL system with LOCI Module..
• Flex type = 8 well, all liquid reagents. All TNI reagents are liquid; however, chemibead
and sensibead reagent wells are mixed by the instrument when the well is first punc-
tured. Mixing is performed by the R2 or R3 probe (RMS). Mixing is accomplished by
aspirating a fixed volume of reagent from the well and then dispensing it back into the
same well (referred to internally as “Sip and Spit mixing”). This process is performed
automatically when a new chemibead or sensibead well is punctured. This process can
be pre-programmed using the inventory/hydration screen.
• Coefficients: C0 = -6.0, C1= 3246.0, C2= -2.0 , C3 = 22.4 , C4= 0.01.
• The TNI method uses the 5-level LOCI TNI calibrator, RC621. During calibration each
calibrator level is analyzed for three replicates. The TNI method is a logit method, and
the calculated slope (m) should be between 0.95 and 1.05. The correlation coefficient
(r) should be between 0.990 – 1.000.
• The assay range for the Dimension EXL TNI method is from 0.017 to 40.0 ng/mL. The
TNI method reports to 3 decimal places. Over-range samples can be manually diluted
with Dimension EXL/Dimension Vista CTNI Sample Diluent (Cat. No. KD692). The rec-
ommended dilution factor is 5.

T Methods 337
Troubleshooting 0
• XLink instructions can be found in the Dimension EXL XLINK Functional Description
(DCIN-A03.850.15 / Introducing Xlink). Chemdata file will contain summarized TNI QC
data. LOCIDATA file contains LOCI reads and module level checks. Standard Dimen-
sion filterdata holds no TNI or LOCI method information. LOCIDATA can be obtained
via the snapshot directory. Software versions 9.0SP3 and higher will have the “get
LOCIDATA” command, which will pull most recent LOCIDATA (similar to “get filterdata”
command).
• The LOCI TNI calibrator is very sensitive to thawing conditions. The IFU states that the
calibrator should be thawed at room temperature for one hour before using. If the cali-
brator is left at room temperature too long, this can result in under recovery of calibrator
and subsequent overrecovery following calibration. Thawing the calibrator at 4 °C (i.e.
in refrigerator) results in lower troponin values by 10% or greater. This low recovery is
not reversible by warming calibrator vials to room temperature after having thawed at 4
°C. If calibrator vials have partially thawed in a failed freezer, they must be discarded.
Calibrators must be stored in a non-frost free freezer.
kcount less than 1/2 the mean recovery of the level A calibrator (zero calibrator). Fre-
quent occurrence of this error indicates either the wrong calibrator level run, or a
reagent delivery issue with the chemibead or biotinylated antibody. If the error is spe-
cific to a single sample, the sample should be diluted 1:2 with a sample that has a
• Measurement errors are generated when the low signal value (1/2 the mean recovery
• LOCI TNI is susceptible to frequent QC shifts when changing reagent lots due to QC
matrix effect. Siemens LOCI TNI has been formulated to be matrix-compatible and can
be used instead of patient samples to demonstrate acceptable reagent performance
when commercial QC products shift when starting a new reagent lot.
handling conditions. Both Bio-Rad and MAS cardiac control products indicate that the
product is stable within their claims when product is stored in a non frost-free freezer.
• Troponin immunoassay reaction is dependent on the absolute temperature setting of
the HM ring. On the Dimension RxL, Xpand systems and EXL systems without LOCI
module, the incubation temperature of the reaction vessel on the HM wheel is 42 °C. On
the Dimension EXL with LOCI Module, the temperature of the HM incubation wheel has
been adjusted to maintain the reaction vessel at 37 ºC for all HM and LOCI methods.
The HM wheel temperature specification on the Dimension EXL with LOCI Module
Daily Maintenance log is 37.3 – 39.6 ºC, this is the temperature range is of the HM ring
itself, not the air bath or liquid in a reaction vessel. If an instrument is somehow set to a

338 T Methods
higher HM ring temperature, TNI assay signal-to-noise will decrease. Assay perfor-
mance drops off sharply at temperatures above 40 °C. Sudden decreases in Troponin
kcount signal accompanied by a drop in signal-to-noise should trigger investigation into
possible temperature issues with the HM module, or incorrect temperature calibrations
made by the customer.
1. Pre-read
2. Assay read
3. Gain read
The Pre-read and Gain reads produce diagnostic information to identify a malfunction-
ing LOCI detector, shutter, or lightemitting diode (LED). Both occur on an empty read
chamber with no vessel present. For TNI, the Assay Read is composed of four assay
and after a 100 msec gate delay, the chemiluminescent signal is collected for 1000
msec. Total signal, reported in kilocounts (kcounts – found in the LOCIDATA file under
the Primary Column with LEGEND: LOCI TNI. This is the sum of the 4 assay read
cycles in counts / 1000). These 4 assay read cycles (referred to as ASY CPM rd 1-4 in
the LOCIDATA file), produce consistent pattern counts at reportable TNI concentra-
tions (see graph below of TNI calibrator levels 2-5). The pattern of the 4 reads may be
valuable as misdelivery of reagent may show an abnormal pattern.
Fig. 24: Normal TNI Cycle Patterns
Results Monitor
• The TNI method uses the ReadVf as a result monitor, this is found in the LOCIDATA file
in the column ASY Tot VF. ASY Tot VF is the sum of the four ASY VF Rd. The ReadVf
measures the amount of light from the LED that gets detected by the illumination photo-
cell. This read occurs when the sample reaction vessel is in the LOCI reader. An unusu-
ally high ReadVf occurs when there is no or a drastically reduced amount of sensibead

T Methods 339
reagent in the assay. The methpar is set up to create an “Abnormal Assay” error in this
case. Likewise, a low ReadVf can occur if the sensibeads have settled and are not suffi-
ciently resuspended during the sip and spit mix routine.
monitor. It passes if it is within +/-20% of this average and is then included in the aver-
used.
Contamination Read
under column Contamination. In prior software versions the Contamination column will
always read “0” – the contamination read can be calculated by multiplying the PRE Tot
CPM column by 3.3333. The contamination value is typically below 45 counts. If a con-
tamination read exceeds acceptable limits it will produce Error 849 - Failed Reader
• Should the system flag a contamination error, the LOCI vacuum cup should be replaced
along with the LOCI insert and retainer rubber seal. LOCI arm alignments should be
performed following replacement. Prior to replacing the vacuum cup, insert and retainer
seal, the HM incubation wheel should be examined to ensure there is not reagent spill-
age that could contaminate the vessel. Close examination should also be done in the
R2 delivery area. Should there be any stray fluids, cleanup should be performed along
with realignment of the R2 arm.
Illumination Read
The Illumination Read is a measurement taken with the illumination photodiode of the illu-
mination LED banks function at the beginning of the pre-read. Acceptable range of the Illu-
mination read is between 150,000 -500,000 counts . In software version 9.0SP3 and higher
the Illumination Read should appear in the column Illumination in the LOCIDATA file. In
prior software versions the Illumination column will always read “0” – the illumination read
can be calculated by multiplying the PRE Tot VF column by 2. The illumination value must
be within 2.5% and 7 standard deviations from the mean. If the value is greater that 7 stan-
dard deviations it must be within 1% of mean. If the illumination read exceeds acceptable
limits it will produce Error 850 - Failed Reader Illumination Check. Illumination failures are

340 T Methods
primarily noise related and the electrical components should be inspected to ensure cable
routing is correct. If problem persists change LOCI board followed by the reader. If noise in
the illumination value is found and corrected the LOCI statistics file should be reset.
Gain Read
• The gain read is taken after the method read. During the gain read the CPM / PMT
response to the gain LED is referenced to the gain photodiode measuring the same sig-
nal. Three values output into the locidata file. These are GAIN Tot CPM, GAIN Tot VF,
(the signal as measured by the gain photodiode,) and the ratio of the two or Relative
Gain. Acceptable Relative Gain ratios are between 1.0- 8.5. Values must also be within
• The Relative Gain ratio can be used as a CPM / PMT drift monitor. Gain ratio should not
drift > 1.0% of the course of a month. If a customer complains of a QC trend overtime or
not meeting the claimed calibration interval, the Relative Gain ratio should be checked.
of Relative Gain ratios from Day 30.
semi/nonfunctional shutter. Next, as normal CPM / PMTsignal response degrades over
time the CPM / PMT may have truly fallen out of its usable life, and have a Relative Gain
ratio of below 1.0. This, however, should not happen for years of use. Persistent gain
read errors or significant CPM / PMT drift would necessitate replacement of the reader.

• Completely missing biotinylated antibody or chemibead reagent eliminates specific
LOCI signal and is expected to result in very low signal counts; slightly lower than cali-
brator level 1. If signal is low enough, it could likely trigger the “abnl reaction” error. At
this time, there is no available data that can specifically flag these failures. Partially
missing biotinylated antibody reagent or chemibead reagent (a short reagent delivery)
is not easily identifiable. The amount of signal loss depends on the amount of reagent
that is missing.
• Non-delivery of sensibead reagent is flagged by Abnormal Assay message. See
Results Monitor .
• Completely missing assay buffer has a subtle effect on LOCI signal. This could easily
go unnoticed. At the low end of the calibration curve, there would be slightly higher
LOCI signal than a normal curve, but above Cal 2, there would be about 5% to 10%
lower signal. The ReadVf signal would be almost 10% higher.
• Completely missing sample eliminates specific signal due to analyte and is expected to
result in signal counts slightly higher than calibrator level 1. This error would not be
flagged. The elevated signal is due to the increased “cross-talk” between chemibeads
and sensibeads that results from the smaller reaction volume and absence of matrix
proteins normally contributed by the sample (which are weak singlet oxygen quench-
ers). Partially missing sample is not easily identifiable. The amount of signal loss
depends on the amount of sample that is missing.

T Methods 341
TOBR 18.7
Method Chemistry 0

1 R1ARM (R4) 71 µL, (H2O) 260 µL N
3 R2ARM (R5) 50 µL (R4) 30 µL, (H2O) 60 µL N

5 R2ARM (R3) 80 µL, (H2O) 40 µL Y
Method Specifics 0
• Pseudo-rate, bichromatic 340/700 nm.

• As with all PETINIA methods, TOBR is a nonlinear method with five C terms. All terms
will change with calibration except the C4; C4 is 0.5.

342 T Methods
• TOBR has a 0.5% NaOH wash to eliminate carryover.
Troubleshooting 0
Error Messages
Abnormal Reaction – Check 700 > 100 mAU

Root Cause
• Photometric issues such as weak source lamp, dirty windows.

Abnormal Reaction – nonsp > 50 mAU

Root Cause
• Sample quality issues such as fibrin strands, clots.
Absorbance – monoPR > 1600 mAU

Root Cause
• Particles aggregated on their own in Flex® well.
Absorbance – Part2 < 400 mAU

Check for the deliver of the particle reagent to the cuvette.
Root Cause
• R1 probe tubing crimped.

T Methods 343
Below Assay Range

TOBR concentration below assay range.
• If the calculated sample concentration confirms the concentration to be < 0.28 ûg/mL,
the result should be reported as “less than 0.28 ûg/mL”.
Above Assay Range

TOBR concentration above assay range.
• Dilute sample with TOBR-free serum or DDRUGCII level 1, enter dilution factor.
Assay Range Diluted

The sample was autodiluted but the result still exceeded the assay range.
• Dilute sample with TOBR-free serum or DDRUGCII level 1, enter dilution factor.
Root Cause
• Flex® reagent exposed to freezing conditions.
Within-Lot Accuracy
Root Cause

344 T Methods
TP 18.8
Method Chemistry 0

1 R1ARM (R1) 85 µL, (H2O) 210 µL N
4 R2ARM (R2) 85 µL, (H2O) 50 µL Y
Total Cuvettel Volume: 500 µL
Method Specifics 0

• No Flex will give results of 3.6 - 3.7. This happens to be the C0 term for TP.
• Final “r3” read at 450 seconds.
• Interfering methods: ALP, LDH.
Troubleshooting 0
• R2 initiated method. Weak R2 mix causes high outliers.

• Wicking indicator
• Abnormal reaction errors occur when 700 check > 40.
Precision Issues
• Check optics and cuvette manufacturing.
• Change sample probe; align and clean sample drain.
• Change sample tubing.
• R1 probe loose or worn.
• R2 probe loose or worn.

T Methods 345
Results Monitor
Tab. 94 Limits
Rslt Optical Mini- Maxi- Above Below Error Mes- Status

Mntr Filters mum mum Mean Mean sage
Reps Reps Factor Factor
A 700 80 250 +10 SD -10 SD abnl assay active
B 510/540 10 250 0.0 0.0 abnl assay not
active

TP A on sample and reagents. Check (R2: CuSO4) delivery by
Endpoints (r3), air blanked, mono- R2arm.
chromatic at reagent max (700). Check Wells 4-6, all reagents liquid.
Analytical is 540/700 nm.
Limits are mean ± 10 SDs
B icterus flag (software version 7.0.1 Default limits are set to zero when using
or higher) software version 7.0.1 or higher.
Result Monitor B uses the 510/540 nm For more information, refer to CSB
filters to detect spectral interference D-0326, dated July 21, 2003
from bilirubins. * To activate the limit, escalate to GPS
for further assistance.
Instruments with 7.0 software have “B” side limits set to zero (0.0) to inactivate B side.
Result Monitor B uses 510 nm and 540 nm filters to detect spectral interference consistent
with icterus. Check Result Monitor B limits if inappropriate error flags are observed with
normal samples.

346 T Methods
TPSA 18.9
Method Chemistry 0

1 R2ARM (R2:CRO2) 30 µL / (H2O) 40 µL N

2 PHOT READ 577/700
4 PHOT READ hardread 577/700
5 PHOT READ 577/700
6 PHOT READ 577/700
Method Specifics 0
• TPSA Reagents
Well 1 - conjugate reagent
Well 2 - Chrome diluent
Well 3 - 1-tablet chrome hydrated with 1,800 µL of chrome diluent
Well 4, 5, 6 - 2 tablets of CPRG hydrated with 1,800 µL of CPRG diluent from well 7
Well 8 - Empty

T Methods 347
• Sequential sandwich assay format, CPRG detection.

• Type ‘c’ method {requires preprocessing in HM module}
• Extended read method (Level = 3).
NOTE FOD error will enable auto-dilute.
• IF (R3OD > 1999.9) = FOD_ERROR

• If (cro2 < 50 || cro2 > 200).
FOAM_ERROR; CrO2 check, abnormal reaction.
• If (rgBlank < 50 || rgBlank > 500).
FOAM_ERROR; R1 reagent check, abnormal reaction.
Troubleshooting 0
Low End Imprecision

• Troubleshoot suspected wash station problems per HM System Check Guide.
• This method is a susceptible to magnetism (uncommon) resulting in low-end precision.
• Refer to SKB ID #SKB0023323 for troubleshooting assistance.
• Contact GPS for further assistance.
CPRG Detection
Abnl Reaction “rgt blank” < 50 mA

• Indicates low CPRG concentration delivered to cuvette.
• If “isolated” event, check for:
- Bad cuvettes
- R1 probe fluidics
• If “multiple” events (i.e. well set), check for:
- Coring.
- Foaming in cuvette / Bad cuvette.
- Reagent well contamination
Abnl Reaction “rgt blank” > 500 mA

• May indicate underhydration of CPRG wells.

348 T Methods
• Check for:
- Caring
- Foaming in cuvette / Bad cuvette
- Reagent well contamination
Polished filterdata for “rgt blank” must be checked to determine high/low failure mode.
Chrome Detection
Polished filterdata for “cro2” must be checked to determined high/low failure mode.
Abnl Reaction “cro2” < 50 mA

Indicates low chrome delivered to cuvette.
• Check chrome remix in Flex®. R2 probe to Flex®.
• Check for chrome loss at wash station. Wash probe alignments.
• Check magnet locations for good chrome separation.
Abnl Reaction “cro2” > 200 mA

Indicates high chrome delivered to cuvette.
• Undissolved chrome tablet.
• Chrome well underhydrated.
• Check proper functioning of mixers for chrome resuspension in vessel.
• Check sample probe to vessel alignment for chrome resuspension in vessel.
Result Monitor
Tab. 96 Limit Table

A 700 15 250 1.2 0.80 abnl Active
assay

TPSA cro2 check, mono-chromatic 700 nm

T Methods 349
TRNF 18.10
Method Chemistry 0

1 R1ARM (R1) 105 µL / (H2O) 200 µL Y
5 R2ARM (R2) 50 µL / (H2O) 60 µL Y
Method Specifics 0

Troubleshooting 0

If the error message is intermittent, check the following:
• Are samples cloudy or turbid? If yes, centrifuge and rerun.
• Have samples been frozen? Samples which have gone through freeze/thaw cycles can
aggregate when mixed with buffer containing PEG; obtain fresh samples.
• What is patient diagnosis? Myeloma samples may spontaneously aggregate when
mixed with buffer or diluted.
• Are windows clean? Dirty cuvette windows may result in absorbances high enough to
trip the abn rxn flag.
• Alignment of sample and reagent probes - misalignment could cause foaming.
• Age of sample and reagent probes - worn probes may cause mixing problems.

350 T Methods
if related methods (C3, C4, IGA, IGG & IGM) are also affected, check the following:
• Tag readings for empty cuvettes - reading at -72 seconds should be around 200 mA for
all wavelengths.
- High reads and high SDs for all cuvettes across all wavelengths may indicate aging
snapshot may read in the 90s (atypically high - high readings to 50-70).

T Methods 351
TSH 18.11
Method Chemistry 0

4 MAGNET Chrome Separation

1 R1ARM (R2:fadp) 30 µL, (R1:apo) 30 µL, (H2O) 300 µL Y
3 PHOT READ hardread turbidmetric 510/700 nm

1 R1ARM (R2:fadp) 30 µL, (R1:apo) 30 µL, (H2O) 390 µL Y
2 SAMPLE (no sample additionl) N

352 T Methods
Method Specifics 0
• Rate, bichromatic 340/700.

• Type ‘c method.
• VANC is a nonlinear method with logit coefficients. All terms will change with calibra-
tion except C4. C4 = 0.5.
Well
1, 2 3-FADP tablets hydrated with 1637 µL of well 7 reagent
3, 4 3-APO tablets hydrated with 1700 µL H2O
6 2-tablet, antibody-chrome hydrated with 1900 µL H2O
7 cascade diluent
8 conjugate
TSH Reaction (Simultaneous Format Cascade Detection TSH Reagents)

• Uses Rabin Cascade where ALP activates another enzyme which produces color.
• TSH with sensitivity of 0.01 needs dynamic range of 50/0.01 = 5000 MA.
• In this method 2 reads are taken - one long read and one short read
- R1 at 48 sec
- R2 at 120 sec
- R3 at 300 sec
• 2 standard curves are generated and combined to one curve = combo curve.
Calibrator Long Short Combo

Level N Conc MA Read MA Read MA Read
14 0.00 0 0
23 1.00 170 170
33 4.00 750 750
42 20.00 > 2000 400 * 4000
52 50.00 > 2000 750 * 7500
* In software routine the short reads and long reads are extrapolated to a combo curve.
• 4 replicates at 0 to obtain better accuracy.

T Methods 353
• Logit equation used with weighting to anchor the low level.

• Zero limit entered to call negative numbers as zero. If numbers too negative - error
code.
• Instrument blows cuvettes to keep constant temperature.
• Temperature sensitivity - 4% per degree, better than with other methods.
• Blank cuvette MAs stored as MCAS QC level 4, typical 40 - 60 mA.
MCAS Reagent Blank

Diagnostics F7, Process Control F5, Method Review F7, ALT (TIBC/TP) key, F6 for QC
level 4.
• If above 100 suspect microbial contamination or conjugate carryover.
• If below 10 suspect no reagent in the cuvette, underhydration, and coring. To address
low blanks at the end of the well, experience has shown that instruments can be
improved by focusing on the R1 pump panel first, then the R2 panel if needed. Improve-
ment in dead volume has been obtained by:
- Changing the R1 probe.
- Checking syringe gap.
- Trimming ends of tubing.
- Changing solenoids.
- Replacing pump motors.
- Replacing pump panel.
Refer to CSB D0349.
• If there is an error after hydration, suspect carryover during hydration - clean R2 probe
outside with NAOH (weekly) and look for a ring outside probe.
• If there is an error after 1-2 days, suspect water microbial contamination or buildup of
phosphates in the reagent.
CRQC
• Active cuvette chrome MAUs at 700 nm, stored at CRQC Level 5.
• Diagnostics F7, Process Control F5, Method Review F7, ALT (PTN), typical 65-130
mA.
- If above 130, suspect chrome underhydration, chrome remix problem, clogged wash
probe or bubbles, foaming, poor cuvette, low cuvette volume.
- If below 65, suspect frozen samples causing clumping from particulates in the sam-
ple.

354 T Methods
Troubleshooting 0
Changes in chrome or blank values, bacterial contamination, alignments, optics and ultra-
sonics all affect the precision and accuracy of this method. Chrome precision and
water/reagent contamination are monitored with Abnormal Reaction flags. Chem Wash
contamination does not have a monitor but may be checked using a Chem Wash test
described below. Optics and mA recovery can be checked using the XLINK function.
The most likely cause for low end TSH imprecision is bacterial contamination of the water
or Chem Wash systems.
Method Imprecision
Analyze in the Following Order:
1. Windows and Source Lamp
• Review the data from the Read One Macro. Visually check the values to see if the indi-
vidual mAU values agree with the calculated mean and SD. Guideline limits: mean val-
ues should be 200 ± 20, SD should be less than 5. Review all data and not just the final
SD provided at the bottom of the Read One Macro.
• If the Read One mAU values are intermittently or consistently high and/or the SD is >
5.0, most likely the windows are dirty or the source lamp is bad.
• If the Read One mAU vis consistently low (<180) or the SD > 5.0, most likely the lamp is
bad or it could also be dirty windows.
• For source lamp replacement, refer to CB-DOC.
2. Chrome
and good optics. Typical chrome precision is < 5.0 SD. If the chrome values on the XLINK
data are imprecise (noisy), perform the following:
• Check sample for clots and fibrin.
• Check wash station, incubation wheel, baseplate, and reagent tray cover for splashing.
• Check for bent or bad reaction vessel clips.
• Check for dirty or bad reaction vessel mixers.
• Check wash station alignment.
• Check for cleanliness of the wash probes.
• Check Sample and R2 alignments (all).
• Clean drains and check sample and probe wash delivery.
• Check for crimps in tubing or loose tubing (R2 and sample).
• If chrome first result is high or low, suspect chrome dissolution/mixing.

T Methods 355
• Check R2 ultrasonic and alignment. Ensure that ultrasonics are firing correctly, espe-
cially after the system is in standby mode for a long time, such as a weekend.
Chrome Flags
If chrome value is above the limit (TSH > 130), suspect sample probe to vessel alignment,
chrome under hydration, chrome remix problem, clogged wash probe or bubbles, foaming,
poor cuvette, low cuvette volume, overactive R2 probe, sample handling causing clumping
from fibrin and/or particulates in the sample. If below (TSH < 65) suspect sample handling
causing clumping from particulates in the sample.
Chrome Processing Assays
Three methods were used during HM development for troubleshooting chrome issues:
CRQC (Chrome QC), CRCV (Chrome to Cuvette), CRRS (Chrome Re-Suspension).
They are included in the commercial software without the need of passwords. The primary
advantages of these methods are:
• They use only the chrome from the Flex.
• Much shorter assay time (about 50%) than standard TSH/FT4 methods.
• They do not require a sample.
They can potentially be used during parts replacement for a known chrome processing
problem to observe before and after data. They use either a TSH or FT4 Flex for the source
of the chrome, and have their own method parameters. A description of the methods and
comparison of method parameters to FT4 and TSH method parameters are found in Ser-
vice Technical Support Service Bulletin D-00023R Appendix 1, which is located in
CB-DOC. A processing for running these tests is found in Appendix 2. The procedure is
similar to RABS, SABS. Please note that these guideline limits are based on a small subset
of instruments.
3. Water/Reagent Contamination
enzymes act like the conjugate (alkaline phosphatase) and will cause the blank rate to
• Very low mA (< 2mA) may indicate missing tablets or non-hydration (coring by R2 dur-
ing hydration).
• Review XLINK blank results for the following: an abnormal reaction error message
occurs if blank readings are TSH > 100. Blank results normally increase a small amount
as the reagent well ages. It can increase as much as 20 to 30 mAU during the three-day
life of the reagent well. Typical is 10-15 mAU. An increase of 30 mAU above the manu-
facturing release blank data may indicate contaminated water or a contaminated
reagent well. The manufacturing release blanks are typically TSH - 15 to 35 mAU.

356 T Methods
• Reagent Contamination: Rapid elevation above manufacturing blank value + 30 mAU,

typically observed immediately or within 1 day. Corrective actions should be performed
in the following order:
- Ensure that prove cleaner is not empty and is flowing to the drain.
- Clean (bleach) and align the R1 and R2 drain and the R1 and R2 probe (clean with
• Bacterial Contamination - Water: Steady rise of blank above manufacturing blank value
+ 30 mAU over a three day period. Gross bacterial contamination may start out (upon
hydration) above manufacturing blank value + 30 mAU and continue to rise over the
three days.
If this is the first case of contamination, decontaminate both the water system and the
Chem Wash system. If this is not the first place, decontaminate the water system back
to the Millipore. If decontamination was performed during the past month, escalate to
GPS before decontaminating again.
NOTE In most cases, contamination is within the hardware sys-

tem/fluidics of the Chem Wash system and not the fluid itself.
If the Chem Wash system is contamined, the polished mAU of samples will trend downward
as the Chem Wash flushes the bacterial phosphatases out of the system, with a corre-
sponding downward trend in analyte results. The effects of this contamination can be seen
as soon as 30 minutes after Standby. To test for Chem Wash contamination:
• Have the HM system in Standby for 30 minutes.
• Using TSH method, run a sample of Level 1 calibrator or freshly opened Chem Wash as
a patient sample (n=10) as XQC. Review the polished mAU on the filterdata and look
for a downward trend with corresponding downward trend in analyte results. A down-
ward trend indicates the need to decontaminate the Chem Wash system. Repeat the
Chem Wash test. If the problem returns within the month, it could indicate a severe con-
tamination problem. Escalata to GPS before decontaminating again.
Cascade methodology requires sufficient and stable (not changing) levesl of dO2 content.
Changes of dO2 of 2 ppm between two measurements of Millipore product water at two
investigated. TSH precision is affected when the dO2 levels are not stable. Experience has
shown that dO2 levels of 3 ppm and lower are often associated with TSH imprecision. Refer
to Service Bulletin D-00016, “Millipore Aeration System”, located in CB-DOC.

T Methods 357
NOTE Day 1/Day 2 testing: mAU values for Level 3 calibrator below
the expected range are suggestive of low dO2 content and
should be investigated. TSH installation limits are 450-875
mAU.
6. Magnetic Effects
• Generally, magnetic effects causing result outliers occur with low frequency.
• Check for updates in the most recent version of the Magnetism Service Bulletin located
in CB-DOC.
• In CB-DOC, refer to Service Bulletin D-00067, “Magnetic Field Effects on HM Assays”,
“Magnetic Field Effects on HM Assays REVISED” to identify potential stray magnetic
fields affecting chrome in the cuvette. A guideline is presented below to help with this
identification.
position 22 and/or position 44) or from the HM module and/or photometer/cuvette bear-
ings.
• HM module bearing ring: a study was performed to observe the effects of magnetism on
cascade methods (CTNI, TSH, FT4) by using a highly magnetized HM module bearing
ring.
Sample used was Chem Wash for CTNI, TSH, DPSA and FT4. The conclusions are as
follows:
- Greatest effect observed with CTNI and TSH.
- When imprecision was observed, mAU outliers were always high as compared to the
mean of results of a non-magnetized HM bearing ring (“before”).
- A magnetic effect was observed with tSH, CTNI polished mAU results; ranked in
order of magnitude. FT4 did not appear to be affected.
- Data is presented in Appendix 3, 4, and 5 of Service Bulletin D-00067.
• Baseplate Area: Guideline filterdata interpretation for identifying possible stray mag-
netic fields.
Stray magnetic fields generally exhibit themselves by lowering the active cuvette, 510

358 T Methods
- Polished mAU on a zero sample is -3 and less.

- Active is < blank by 10 or more mAUs on a sample with no analyte (Chem Wash or
0.00 patient results). Typically the Active-Blank = ± 5. This is generally systematic
- The Read 4 - Read 2 mAU is < 12 on a sample with no analyte (Chem Wash or 0.00
patient samples). This is systematic across multipl zero level samples. Normally, this
value is 20-30 mAU. Removing the chrome from the Flex and replacing with water
yeidl (active=blank) ± 5.
present on the instrument. These are displayed in Service Bulletin D-00067, Appen-
dix 8. Notice from these graphics atypical shifts in mAU at the second and third pho-
tometric reads. This is indicative of possible stray magnetic fields in these areas of
the instrument (cuvette position 22 and/or 44 for RxL).
- These recommendations are only guidelines that may suggest acquiring a gauss
meter from GPS to identify if a stray magnetic field may be present on the instrument.
- A gauss meter should be used to identify magnetic effects on HM assays. Refer to
Service Bulletin D-00067, “Magnetic Field Effects on HM Assays”.
- Representative data with HM module bearing magnetism present and absent is dis-
played in Appendix 3. Also included are the specifications with failed data highlighted
in bold.
Accuracy
Sample
• Bacterial contamination of water or Chem Wash systems.
• Clots or particulates in the sample cause chrome clumping.
• Missing or extra tablets in the Flex well.
• Under-hydration, perhaps due to coring.
• Poor temperature control (e.g. running with lid open).
• Low dO2 content of the water.
Day 1 and 2 Testing

Level I
• Failed SD Limit
- Alignments.
- Bacterial contamination of water or Chem Wash system.
- Magnetism.
• Failed Mean Limit:
- Bacterial contamination of water or Chem Wash system.

T Methods 359
Level III
• Failed SD Limit
- Bleach contamination.
- Low dO2 content.
- Low HM incubate wheel temperature.
- Gross bacterial contamination.
• Failed Mean Limit
- Residual bleach contamination.
- Low dO2 content.
- Low HM incubate wheel temperature.
Error Flag
NOTE Order is important.
FOD is lowest priority, others equal

if (fod150s > 1600) /* high sample trap */
FOD_ERROR;
if (blank > 100) /* cascade upper limit */
FOAM_ERROR;
if (blank < 2) /* cascade lower limit */
FOAM_ERROR;
if (r2cro2 < 65 || r2cro2 > 130)
FOAM_ERROR; /* cro2 check, abnormal reaction */
Results Monitor
Tab. 98 Limits
Rslt Mntr Optical Mini- Maxi- Above Mean Below Mean Error Mes- Status
Filters mum mum Factor Factor sage
Reps Reps
B 510/700 15 250 40 0 abnl assay active

360 T Methods

T Methods 361

TSH Result A • Troubleshoot for chrome dissol
• Chrome level at 700 nm. probe/ultrasonics) if results are
normal (expected)
• Air blanked difference between chrome cuvette (test)
and the cascade cuvette (blank) • Possible sample handling issue
not be outside the result monit
• Limit +19% or -17% be atypical compared to all the
• Typical chrome SD < 5.0 D-01171, “Preanalytical Variab
the Dimension CTNI and D-024
men Preparation and Handling
Styletting of the wash probes is
nance. Frequent required stylet
(within a week), CrO2 SD resu
up to 5 after styletting are indic
dling is an issue.
• If low chrome occurs on more th
solution of the tablet is not the
following:
- check alignment of the wash
- replace wash probes.
- replace cassettes.
- replace HM tubing harness.
- evaluate pump panel (tubing
ing from HM wash station ca
tle, vacuum sensor).
- diluent/aspirate lines reverse
• W1BS, W2BS is useful for trou
problem in waste station area.
reagent cartridge manually as
W2BS. Order W1BS (n=5) usin
and W2BS (n=5) using the ALT
ple is required. A record of the
System Check can be found in
using the ALT/GGT/LIP keys,
ALT/GLU/MG keys. Acceptance
value, SD < 1.6.
• High chrome can be caused by
chrome well or foaming. Foami
caused by the sample probe.
• To check for proper function of
- temporarily remove the two w
wash station housing and pla
tube.
- using the Pump Prime routin
PUMP to prime the wash pu
- Observe the fluid in the test
Restricted 10.14 H DX GPS D prime. If the system is functi
should fill the tube, then emp
turned on.
362 T Methods
* The Results Monitor alert will not manifest itself as an error that prevents a result from
being reported but rather as a warning, signaling to the customer that their HM system
needs attention. No error flag will be appended to the result, results can be released. Blank
values are monitored for an absolute increase of 40 mAU above the mean value. When this
limit is exceeded a red Results Monitor warning will be posted in the warning area under
the status boxes on the Dimension Operator screen. The audible alarm will not sound. The
Results Monitor alert will trigger a minor error [803] that will be posted in the error log
together with the mnemonic of the method, producing the error (from the Operating menu,
select F5 PROCESS CTRL; F6 ERROR LOG). The minor error text will provide guidance.

T Methods 363
TSHL 18.12
Method Chemistry 0
Reaction Vessel
Event # Event Time Delivery Volumes/ Filters Mix

1 R2ARM -953.6 sec R2 (Chemibead-Ab) 10 µL Y
R1 (Biotinylated-Ab) 20 µL
2 SAMPLE -942.2 sec (Sample) 12 µL, (H20) 3 µL Y
3 R2ARM -511.8 sec R3 (Sensibead) 12 µL, (H20) 10 µL N
4 R2ARM -53.9 sec R3 (Sensibead) 0 µL, (H20) 183 µL N
5 LOCI ARM 0 sec LOCI read vessel (4 reads) -
Method Specifics 0
• LOCI® method, a homogeneous, sandwich, chemiluminescent assay.

• The TSHL method is only available on the Dimension® EXL™ system with LOCI®
Module.
• Flex® type = 8 well, all liquid reagents. All TSHL reagents are liquid; however, Chemi-
bead and Sensibead reagent wells are mixed by the instrument when the well is first
punctured. Mixing of Sensibead is performed by the R2 or R3 probe (RMS). Mixing of
sensibead is accomplished by aspirating a fixed volume of reagent from the well and
then dispensing it back into the same well (referred to internally as “Sip and Spit mix-
ing”). This process is performed automatically when a new Sensibead well is punc-
tured. The Chemibead wells are mixed by sonication prior to use. Mixing of Sensibead
and Chemibead can be pre-programmed using the inventory/hydration screen..
TSHL Flex Configuration (8 well flex)

1,2 Biotinylated TSH Ab Liquid
3,4 TSH antibody Chemibeads Liquid
5,6 Streptavidin Sensibeads Liquid
7,8 Assay Buffer Liquid

364 T Methods
• Coefficients:
- C0 = -100.0,
- C1=18456.0,
- C2= -1.1,
- C3= 80.0,
- C4 = 0.01.
• TSHL method uses the LOCI THYR Cal (RC610A) for calibration. Level 1 is not
included in the LOCI THYR Cal carton. Calibrator levels 2-6 are used for calibration of
the TSHL method. During calibration each calibrator level is analyzed for three repli-
cates. The TSHL method is a logit method, and the calculated slope (m) should be
between 0.95 and 1.05. The intercept (b) should be 0.0 or clinically insignificant. The
correlation coefficient (r) should be between 0.990 – 1.000.
• The assay range for the Dimension TSHL method is from 0.007 to 100mIU/mL. The
TSHL method reports to 3 decimal places. SAmples with results in excess of
100mIU/mL should be TSH Sample Diluent, Cat. No. KD691 or MULTI 2 Sample Dilu-
ent, Cat. No. KD694, to obtain results within reportable range. The recommended dilu-
tion factor is 5. Samples with results less than 0.007 mIU/mL should be reorted as “less
than 0.007 mIU/mL”.
Troubleshooting 0
• XLink instructions can be found in the EXL with LM Service Guide. Chemdata file will
contain summarized TSHL QC data. LOCIDATA file contains LOCI reads and module
level checks. Standard Dimension filterdata holds no TSHL or LOCI® method informa-
tion. LOCIDATA can be obtained via the snapshot directory. Software versions 9.0SP3
and higher will have the “get LOCIDATA” command, which will pull most recent LOCI-
DATA (similar to “get filterdata” command).
Kcount less than 1/2 the mean recovery of the level 2 calibrator (zero calibrator). Fre-
quent occurrence of theis error indicates either the wrong calibrator level run, or a
reagent delivery issue with the Chemibead or Biotinylated Antibody. If the error is spe-
cific to a single sample, the sample should be diluted 1:2 with a sample that has a
of level 2 calibrator) used to trigger the abnormal reaction error is missing. This can
occur if the calibration is processed but not accepted..
• Ultra-sonic mixing creates foam and a ring of bubbles at the 45 µL immunoreaction
meniscus (following sample addition). The presence of this ring of bubbles is normal
and remains throughout the LOCI® read and vessel disposal.

T Methods 365
• The LOCI® Read routine is composed of 3 distinct reads which occur in this order: 1)
Pre-read, 2) Assay read, and 3) Gain read. The Pre-read and Gain reads produce diag-
nostic information to identify a malfunctioning LOCI detector, shutter, or lightemitting
diode (LED). Both occur on an empty read chamber with no vessel present. For TSHL,
the Assay Read is composed of four assay read cycles. For each assay read cycle, the
reaction vessel is illuminated for 500 msec, and after a 100 msec gate delay, the chemi-
luminescent signal is collected for 1000 msec. Total signal, reported in kilocounts
(kcounts – Found in the LOCIDATA file under the Primary Column with LEGEND:TSHL
signal. This is the sum of the 4 assay read cycles in counts / 1000). These 4 assay read
cycles (referred to as ASY CPM rd 1-4 in the LOCIDATA file), produce consistent pat-
tern counts at reportable TSH concentrations (see graph below of calibrator levels 3-6).
The pattern of the 4 reads may be valuable as misdelivery of reagent may show an
abnormal pattern.
Fig. 25: Normal TSHL LOCI Cycle Patterns
Results Monitoring
• The TSHL method uses the readVF as a result monitor, this is found in the LOCIDATA
file in the column ASY TOT VF. ASY TOT VF is the sum of the four ASY VF Rd. The
settled and are not sufficiently re-suspended during the sip and spit mix routine.
monitor. It passes if it is within +/-20% of this average and is then included in the aver-
used.

366 T Methods
Contamination Read
under column Contamination. (In Prior software versions the Contamination column will
always read “0” – The Contamination Read can be calculated by multiplying the PRE
Tot CPM column by 3.3333) The contamination value is typically below 45 counts. If a
contamination read exceeds acceptable limits it will produce Error 849-Failed Reader
should be performed following replacement. Prior to replacing the vacuum cup, insert
and retainer seal, the HM incubation wheel should be examined to ensure there is not
done in the R2 delivery area. Should there be any stray fluids, cleanup should be per-
Illumination Read
The Illumination read is a measurement taken with the illumination photodiode of the illu-
mination LED banks function at the beginning of the pre-read. Acceptable range of the Illu-
mination read is between 150,000 -500,000 counts . In software version 9.0SP3 and higher
the Illumination Read should appear in the column Illumination in the LOCIDATA file. (In
Prior software versions the Illumination column will always read “0” – The Illumination Read
can be calculated by multiplying the PRE Tot VF column by 2) The Illumination value must
be within 2.5% and 7 standard deviations from the mean. If the value is greater that 7 stan-
dard deviations it must be within 1% of mean. If the illumination read exceeds acceptable
limits it will produce error Error 850- Failed Reader Illumination Check.
Over illumination failures may be caused by:
• Noise related to electrical components, inspected to ensure cable routing is correct. If
• Combination of instrument LOCI® reader sensitivity and reagent lot reactivity. If errors
started with new lot of reagent contact CCC/RSC. Do not replace parts.
• Patient samples rarely cause TSH over illumination errors.

T Methods 367
Gain Read
values output into the LOCIDATA file. These are GAIN Tot CPM, GAIN Tot VF, (the sig-
nal as measured by the gain photodiode,) and the ratio of the two or Relative Gain.
Acceptable Relative Gain ratios are between 1.0- 8.5. Values must also be within 4% of
the running mean and 5 standard deviations.
1.0% of the course of a month. If a customer complains of a QC trend overtime or not
meeting the claimed calibration interval, the Relative Gain ratio should be checked.
of Relative Gain ratios from day 30.
below 1.0 (this, however, should not happen for years of use.) Persistent gain read
Ambient Temperature
During development, the TSHL method showed susceptibility to ambient temperature
shifts. Design changes were made to address this including redesign of the H.M. ring ther-
mal control. The worst case situation is calibrating TSHL at 18°C (64°F) and recovering
samples at 30°C (86°F), shifts in TSHL recovery of ~ 10% can be observed . (18°C and
30°C are instrument operating extremes).
Non-delivery of Reagents or Sample

result in signal counts slightly higher than calibrator level 2, and results ~ 0.01 – 0.04
µIU/mL. This is due in part to the increased “cross-talk” between Chemibeads and Sen-
sibeads that results from a smaller reaction volume. It may also caused by the absence
of Bio-Ab which partly covers the Sensibeads during the assay reaction and appears to
render them less susceptible to interact with Chemibeads. Partially missing Bio-Ab is
not easily identifiable. The amount of signal loss depends on the fraction that is missing.
background. Signal will be extremely low; below 1 Kilo-count. A “Below Assay Range”
error should appear when Chemibead reagent is not delivered. Partially missing
• Non-delivery of sensibead reagent is flagged by Abnormal Assay message - see results
monitoring section above.
• Completely missing sample eliminates the specific signal. Partially missing sample is
not easily identifiable. The amount of signal loss depends on the fraction that is missing.

368 T Methods
Water is Substituted for Level-2 Calibrator

TSHL and FT4L both use EXL Thyroid Calibrator (RC610). Given the FT4L method uses
water as its zero-level calibrator, a customer could inadvertently substitute water instead of
the Level-2 calibrator during a TSHL calibration. Water and Level-2 calibrator produce very
similar signal, and calibration curve using water yields excellent curve fit and acceptable
serum/QC recovery above 0.5 µIU/mL. Low-end results would be slightly decreased.
Sample Dilution
Samples that are greater than 100 µIU/mL can be manually diluted with Vista/EXL TSHL
Sample Diluent, Cat. No. KD691. The recommended dilution factor is 5. Total precision at
80 µIU/mL is 6%. High patient sample dilutions could appear to exhibit non-linearity, when
precision of the high measurements is the more likely cause of any discrepancy. Custom-
ers could be advised to dilute high samples to below 40 µIU/mL for most accurate high
sample reporting.

T Methods 369
TU 18.13
Method Chemistry 0

1 R1ARM (R1)100 µL, (H2O) 25 µL N
3 R2ARM (R2) 75 µL, (R3) 50 µL, (R4) 50 µL, Y
(H2O) 25 µL
4 R2ARM (R5) 50 µL, (H2O) 25 µL Y
Method Specifics 0

• TU method does extra reagent probe washes before entering the cuvette.
• TU is a triple dip method.
• When calibrating the TU method, the uncalculated calibrator results may have Arith-
metic errors. Press Calculate and review calibration statistics and QC.
• Do not dilute specimens that are above or below the assay range.
Troubleshooting 0
Accuracy
• TU is very temperature sensitive. 1.0°C = 4.0 units change in TU.
• TU is very sensitive to photometer positioning. Make sure that the thermal chamber
insulation and photometer cables are not interfering with the photometer. Lubricate the
photometer bearing.
• Calibration is sensitive to calibrator hydration. Follow the procedure in the calibrator
insert carefully.

370 T Methods
• Troubleshoot QC shifts by running a new QC Flex®. Common wells may be contami-

nated and opening a new well in the same Flex® may not help.
• Well-to-Well Shift:
- Reagent hydration problems will cause accuracy problems if a reagent lot is cali-
brated using a poorly hydrated well due to: incomplete tablet dissolving – to check,
prehydrate a well for 30 to 60 minutes floating tablets during reagent hydration – align
reagent probe.
- Diluting of well 5 or 6 (R3) can increase a TU result by 1-3 units. Diluting of R3 may
happen because R3 is in the middle of a triple dip and will be diluted if some R4 drips
into R3. R4 is the first reagent aspirated in the triple dip. Look for worn R2 reagent
probe tip, a leak in the tubing, buildup in the reagent tubing, or poor vacuum.
• If wells 2 and 3 are under-hydrated by >250 µL, results will increase by 2-8 units.
Precision
• To test precision, run a 15-test precision run. Calculate SD and CV for three 5-test
groups (1-5, 6-10, 11-15). Refer to insert for precision guidelines. Running 15 tests will
cause the instrument to use reagent from two wells, 10 from the first and 5 from the sec-
ond.
If each of the 5 test groups is outside the stated specifications, troubleshoot the reagent
side of the instrument. Replace the R2 probe tip, check alignments, and change R2 tub-
ing. If not fixed, replace the R2 500 µL syringe tip.
If the five test groups are within acceptable performance, but there is a definite accu-
racy shift between the second and third group, troubleshoot the reagent prep area (R2)
of the instrument. Replace the R2 2500 µL syringe tip. If not fixed, replace R2 ultrason-
ics.
• Imprecision at the ends of the assay range: The ends of the curve of the EMIT methods
tend to level off, causing results from the ends of the curve to have poorer precision
than results from the middle of the curve. As the curve becomes flat at low and high
concentrations of analyte, there is a smaller change in absorbance for each unit change
in analyte. To prove that the imprecision is a method problem and not an instrument
problem, view the results in MAU.
In the Method Review screen, call up the patient specimen in question. Press the F7
function key to toggle the function to Show MAU. Toggle between the result and MAU
values for each patient. Note the larger change in MAU per Unit change for specimens
within the Reference Range as compared to the smaller change in MAU per Unit
change.

U Methods 371
19-
UCFP
19U Methods
Method Chemistry 0
Tab. 100 First Cuvette (test)

1 R1ARM (R1) 350 µL, (H2O) 20 µL Y

Tab. 101 Second Cuvette (probe wash)

1 R1ARM (R2) 360 µL N
Method Specifics 0
• Endpoint, bichromatic 600/700 nm with volume corrected blank.

• Two cuvette method. The second cuvette serves to clean the reagent probe tip with
NaOH(R2) to prevent carryover of (R1) into other methods.
• Must have an assay and reference range entered for urine and CSF on method param-
eters screen.
• CAP sample (dilution issue and failures).
Troubleshooting 0
• Check for high analyte samples; high “A” error flag. Make a 1:4 manual dilution.
- FOD error is calculated from ratio 510/600 <0.85 and 510/510 >1.25.

372 U Methods
• Disregard “high ‘A’ errors” obtained for level 5 during calibration. Press calculate and
accept.
• PHOT READ from second cuvette not used in calculations.
• Absorbance error. The mAU at the measuring wavelength exceeded 2000 or the FOD
limit set in the software. Manually dilute sample and rerun.
• Abnormal reaction occurs when the 700 check is > 80, indicating foaming or turbidity
occurred in the reaction cuvette.
a) Replace sample probe and align.
b) Change sample tubing.
c) Replace R1 probe and align.
a) Change R1 tubing.
b) Check cuvette manufacturing.
c) Check diaphragm is seated properly.
• Carryover pairs: ETOH/UCFP, PTN/UCFP

U Methods 373
URCA 19.1
Method Chemistry 0

Method Specifics 0

• Type ‘a method.
• Only method that uses 293 filter.
• Dimension® RxL / RxL Max non- HM Module: (see AUD for additional details) .
• Dimension® RxL / RxL Max/EXL/EXL with HM Module: (see AUD for additional
details) .
dilution is performed using 100 µL Sample Syrnge for sample aspiration and 2500µL
ple to the cuvette.
• .Dimension® Xpand®ρεγ and Xpand® Plus clinical chemistry system: (see AUD
for additional details)
ric Cuvette. PUD (Photometric Urine Dilutions). The dilutions are performed using
100µL Sample Syringe for sample aspiration and 500µL R1 Metering Syringe for the
dilution. The Photometric Sampler transfers the diluted sample from the first cuvette to
the second cuvette.
• Samples containing formaldehyde have a negative interference with uricase methods.
• 24-hour urine specimens should be preserved with NaOH [10 mL of 5% (w/v) NaOH].
The preservative volume per collection is determined by each laboratory.

374 U Methods
Troubleshooting 0
• URCA is very sensitive to sample mix, foaming/turbidity/light..

• Precision problems are caused by poor sample mix, foaming in the cuvette, a dirty
sample drain, wicking, cracked windows, a weak source lamp or bad 293 filter. (Review
filterdata.) Hard read 1 at 9.1 seconds.
• Accuracy - QC low (1-2 mg/dl), patients may or may not shift calibrators recover
bottle values when run as unknowns. Problem is most likely caused by a bad 293 fil-
ter. Nonlinear calibration may be caused by bad source lamp.
• URCA results close to “0” or a negative number. Repeats of same sample give a
reasonable result. Precision runs look acceptable. Possible cause wicking (low with CA
and PHOS and high with TRIG). Other possible causes are poor sample mix or DC
power board.
• LOW URCA: weak source lamp or 293 filter, lamp voltage set too low, bad log amp.
• No reagent mix will lower results by 1.0 mg/dL.
• URCA results 50 % low: could be caused by bad source lamp circuit on DC power
board.
• Absorbance errors on patients with a GOOD Result: This can be caused by a spe-
cific type of serum
• New 293 (294) nm filter and log amp on XL improve accuracy.
• Abnormal reaction errors due to foaming will show a large change in the 700 filter
going from read 0 to read 1. (If read 1 minus read 0 is greater than + 30, then foaming
occurred.) To resolve foaming, adjust sample probe to cuvette alignments. Make cer-
tain that the probe is in the center of the cuvette and adjust downward. If necessary,
adjust the cuvette ring position sensor to reposition the cuvette better under the sample
addition hole
• Accuracy - URCA QC, patients and calibrators drop low within lot: Do not cali-
brate out the problem. When the calibrators recover low it is usually a problem with
reagent hydration. To hydrate the reagent, the instrument needs to aspirate very vis-
cous glycerol reagent from well #8, (using the R2 2500µL syringe) and dispense into
wells 4, 5 or 6 to prepare the working reagent. A bad R2 2500µL syringe tip may not
aspirate enough of the reagent
NOTE URCA uses the R2 500µL and 2500 µL syringes for

intra-Flex® reagent preparations. R1 arm uses 500 µL
syringe to deliver reagent components to the cuvette.
• Check for hydration errors. Change R2 probe tip.

• Check source lamp voltages/replace DC power board.

V Methods 375
20-
VALP
20V Methods
Method Chemistry 0
Tab. 102 First Cuvette (pretreatment)

1 R1ARM (R1) 0 mL / (H2O) 380 µL N
2 SAMPLE 3 mL, (H2O) 77 µL Y
Tab. 103 Second Cuvette (test)

1 R1ARM (R2) 60mL, (R1) 120 mL, (H2O) 85 µL N
2 R2ARM (first cuvette) 60 mL, (H2O) 40 mL Y
5 R2ARM (R3) 60 mL, (H2O) 40 µL Y
Method Specifics 0

• Coefficients: C0 = -6.0, C1= 3246.0, C2= -2.0 , C3 = 22.4 , C4= 0.01.
• As with all Petinia methods, VALP is a nonlinear method with five C terms. All terms will
change with calibration. except the C4; C4 is 0.5.
• Measures Depakene®

376 V Methods
Troubleshooting 0
since this may alter Particle Reagent and can cause gross imprecision.
• Due to dynamic assay range, 0-150 µg/mL, the assay is susceptible to imprecision at
both ends of the curve. This is usually observed during calibration, especially at the cali-
brator level 5. If level 5 appears to be imprecise, run 10-test over 2 wells at one of the
troubleshooting levels. If troubleshooting guidelines were not met, troubleshoot sample
and reagent arms and ultrasonics.
• Susceptible to water contamination problems.
• “FOAM_ERROR” occurs if “monoPR > 1600”
• “FOAM_ERROR” occurs if “nonsp > 50”
nonsp = detects non-specific particle aggregation rates prior to antibody. For example,
if a small fibrin clot is added to the cuvette, the monochromatic rate between r2 and r3
would be abnormal and an error message will be printed.
• “FOAM_ERROR” occurs if “part2 < 300”
Particle blank = ensures that particles were delivered and not short-sampled.
• “TIME_ERROR” occurs if “check700 > 100”
Time Error = Ensures that the instrument does not accidentally schedule the fourth read
to come after the fifth read. If the readings are switched, there could be a mathematical
error.
• “below assay range” samples should be confirmed by dilution with an equal volume of
calibrator or control product of a known value. If the calculated sample concentration
confirms the concentration to be < 3.0 µg/mL, the result should be reported as “less
than 3.0 µg/mL (21 µmol/L).”
• “above assay range” samples will be diluted automatically by the instrument if the auto-
dilute feature is configured. Recommended diluents for manual dilutions are Drug Cali-
brator II level 1 and laboratory reagent grade water.
• Check 700. Checks for foaming.

V Methods 377
VANC 20.1
Method Chemistry 0

1 R1ARM (R4) 50 µL, (H2O) 350 µL N

3 PHOT READ 340/700 -
4 PHOT READ 340/700 -
5 R2ARM (R3) 80 µL, (H2O) 40 µL Y
6 PHOT READ 340/700 -
7 PHOT READ 340/700 -
Method Specifics 0
• Rate, bichromatic 340/700.

• Type ‘c method.
• VANC is a nonlinear method with logit coefficients. All terms will change with calibra-
tion except C4. C4 = 0.5.

378 V Methods
Troubleshooting 0
• Recalibrate if you replace source lamp, optical filter, or photodiode..
• Make sure that Flex® reagent has not been frozen by the instrument or the refrigerator,
since it may alter Particle Reagent and can cause gross imprecision..
• R1 reagent contains detergent.
Error Messages
Abnormal Reaction Check 700>50 mAU
• Root Cause.
- Weak source lamp.
- Dirty or improperly aligned photometer lenses.
- Photodiode: Perform inner/outer check. If not within 80 mAU, replace photodiode.

Abnormal Reaction nonsp > 50 mAU

• Root Cause.
- Sample quality issues such as fibrin strands, clots.
- Sample probe misaligned or worn.
Absorbance monoPR > 1200 mAU
• Root Cause.
- Particles aggregated on their own in Flex® well.
Absorbance Part2 < 350 mAU
• Root Cause.
- R1 probe tubing crimped.
Below Assay Range
VANC concentration below assay range.

V Methods 379
Above Assay Range
VANC concentration above assay range.
• Dilute sample with VANC-free serum or DDRUGCII level 1, enter dilution factor.
NOTE Autodilute feature is not available for this method.
Root Cause:
1. Photometric issues such as weak source lamp, dirty cuvette windows.
2. R2 probe misaligned or worn.
3. Reagent mixing inadequate due to R2 probe ultrasonics.
4. Sample probe misaligned or worn.
5. Sample mixing inadequate due to ultrasonics.
6. Flex® reagent exposed to freezing conditions.
Within-Lot Accuracy
Root Cause

380 Service Methods
21Service Methods 21-
Tab. 104 Service Methods
Test Key Combina- Instrument Compo- Specifications Sample Flex Required

Name tion nents Required (Name)
PQC Control-5 340 nm filter only, pho- All readings ≤ 2.5 None None
tometer, cuvettes, win-
dows
PXQC Control-F6 All wavelengths, pho- All readings None None
tometer, cuvettes, win- should be 0
dows
R1BS Control-F2 Reagent 1 ABS carton ± 12; None Yes (R1BS)
CHK carton ± 15;
sd < 3.80
R2BS Control-F4 Reagent 2 ABS carton ± 12; None Yes (R2BS)
CHK carton ± 15;
sd < 3.80
SABS Conrol-F3 Sample Mean = 10% ABS or CHK None
carton value ± 2;
sd < 0.8
SCHK User Defined Sampler Reagent 2 Mean = 10% None Yes (SCHK)
carton value ± 2;
sd < 1.6
W1BS Alt-GGT HW Wash Mean = 10% None Yes (W1BS)
Probe 1 carton value ± 4.0;
sd <1.6
W2BS Alt-GLUC HM Wash Mean = 10% None Yes (W2BS)
Probe 2 carton value ± 4.0;
sd < 1.6
CLRX Alt-PCHE Sample probe cleaner > 100 Yes - any fluid None
NAOH Alt-PHNO Reagent probe > 50 None Yes (NAOH)
cleaner
RIMS Shift-P10 RMS syringe Mean = ± 12 None Yes (RIMS)
carton value;
sd < 3.8

Service Methods 381
Test Key Combina- Instrument Compo- Specifications Sample Flex Required

Name tion nents Required (Name)
SAIR Control-F8 LOCI module 0.001 < x < 0.144; None None
sd < 0.1
DABS Shift-P9 Sample flush syringe Mean = 10% ABS or CHK None
(HM) carton value ± 2; (Fluid setting
Urine)
sd < 1.4
DABS Shift-P9 Monopump IMT sam- Mean = 10% ABS or CHK None
(Non-HM ple dilution process carton value ± 2; (Fluid setting
) Urine)
sd < 1.4
HABS Control-F1 Reagent 2 flush ABS carton ± 12; None Yes (HABS)
syringes CHK carton ± 15;
sd < 3.8
TSH Alt-TSH HM -15 ≤ Μεαν ≤ 25; Chemistry TSH
sd ≤ 1.0 Wash
MCAS Alt-TIBC HM 1 ≤ Mean ≤ 60 Chemistry TSH

Wash
CRQC Alt-PTN HM 65 ≤ Mean ≤ 110; Chemistry TSH
sd ≤ 5.0 Wash

382 Service Methods
DABS/DCHK 21.1
Method Chemistry 0

1 R1ARM R1 0µL, (H2O) 345 µL Y
2 PHOT READ ABS: 510/405 nm or CHK 510/600 nm
4 PHOT READ ABS: 510/405 nm or CHK 510/600 nm

• Sample transferred from aliquot wheel or HM vessel, which is 1:10 dilution. The final
dilution in the DABS/DCHK cuvette is 1:87 {(50 µL sample in 435 µL total volume) x 10}.
- In the aliquot wheel or HM vessel the sample is diluted 1:10.
- In the DABS/DCHK cuvette, the sample is diluted 1:10.
- Final dilution is 1:87 (8.7 x 10).
• In SABS the sample is diluted 1:80 (5 µL sample in 400 µL diluent = 1:80).
• In the methpar polished [0] use a factor of 1.088. This factor accounts for net dilution dif-
ferences between SABS and DABS (87/80).
• Note that the report does not multiply this result by 10 (Urine dilution factor) as it does
with other auto-diluted samples.
Method Specifics 0
• DABS/DCHK method key: <SHIFT + P9>.

• Fluid type must be urine.
• DABS/DCHK is performed using ABS or CHK Flex®
reagent cartridges.
• ABS (DF79) solution uses Cobalt Sulfate (CoSO4)
• CHK (DF179) solution uses Ponce S
• DABS/DCHK is used to check accuracy and precision of sample dilution in the aliquot
wheel or sample vessel (HM).
- DABS/DCHK on systems with HM - tests the precision of the urine dilution process,
sample probe, sample flush syringe
- DABS/DCHK on systems without HM - tests the precision of the monopump dilution
• Expected results: 10% of the bottle value ±2 mA, 1 SD less than or equal to 1.4.

Service Methods 383
Non-HM
• ABS/CHK solution is diluted using monopump, checks IMT probe and IMT tubing.
• A 1:10 dilution occurs in the aliquot wheel.
• Photometric sampler transfers diluted fluid from the aliquot wheel to the cuvette. Five
DABS assay run with the system check.
- Five DABS/DCHK tests run with the system check.
- ABS/CHK results are not corrected for dilution factor.
HM
• CHK/ABS solution is diluted using Sample Flush-syringe (2500 µL). A 10:1 dilution is
performed in an HM-vessel.
• Photometric sampler transfers diluted fluid from the vessel to the cuvette.
- Five DABS/DCHK tests run with the system check.
- ABS/CHK results are not corrected for dilution factor.
Troubleshooting 0
Low Mean
• Loose, crimped, damaged or partially plugged IMT probe tubing.
• IMT probe is misaligned.
• Plugged IMT probe.
High Mean
• Loose, crimped, damaged or partially plugged IMT probe tubing.
• IMT probe is misaligned.
• Plugged IMT probe.
• Aliquot wheel not seated properly.
• Sample probe is misaligned to the aliquot wheel.
SD > 1.4
• Loose, crimped, damaged or obstructed water supply tubing.

384 Service Methods
• Monopump.
- Ensure thumbscrew is tight.
- Change rotary valve seal.
- Check lip seal tightness.
- Lubricate lip seal.
- Check valve body for obstructions.
- Change lip seal.

Service Methods 385
HABS 21.2
Method Chemistry 0

1 R1ARM (R1) 400 µL N
2 PHOT READ 510/405 for ABS and 510/600 for CHK
3 SAMPLE NONE
4 PHOT READ 510/405 for ABS and 510/600 for CHK
Method Specifics 0
• HABS tests the fluid delivery accuracy of the reagent large pump used for hydration,
(R2 Flush).
• HABS key is: <CTRL + F1>.
• ABS/CHK well 1 contains 635/640 µL of R1 component. Well 7 is normally empty. For
HABS test, 450 µL of well 1 is transferred to well 7 and 3150 µL of water is added. This
is sufficient for 5 HABS tests. This is a 1:8 dilution.
• 500 µL syringe delivers prepared reagent to the cuvette.
Troubleshooting 0
• Fluidics.
• Defective R2 pump panel syringes.
• Crimped or pinched R2 probe tubing.
• Overflowing R2 wash drains.
• Worn out reagent probe tip.
• Defective R2 pump panel valve.
• Poor R2 ultrasonic mix.

386 Service Methods
RIMS/RMS 21.3
Method Chemistry 0

1 R1ARM (R4) 420 µL + (R4) 30 µL + (R4) 30 µL Y
+ 10 µL air bubble/dispense only 400 µL
2 PHOT READ 510/405 nm for ABS and 510/600 nm for CHK
3 PHOT READ 510/405 nm for ABS and 510/600 nm for CHK
Method Specifics 0
• Photometric method RIMS (using ABS or CHK Flex reagent cartridges).
NOTE RIMS is the internal company test abbreviation for the RMS
test portion of System Check. The RMS test is included in
System Checks only if the Reagent Management System
Module is installed and is configured ON. The RMS test chal-
lenges the accuracy and precision of both the R3 Arm and its
RMS pump and the R1 Arm aliquot function.
• RIMS keyboard mapping: key: <SHIFT + P10 >, useful when scheduling individual
RMS tests for troubleshooting.
• One ABS/CHK Flex will support two RMS System Checks.
ABS/CHK well #3 provides 350 µL of ABS/CHK to well #7 to be blended and diluted with
2450 µL. The resultant 2800 µL of solution is used unchanged in the five RMS test
cuvettes. Each cuvette receives 400 µL of solution. An additional 80 µL of solution per
cuvette is sent to waste. 300 µL of solution is left unused in the #7 well and is later dis-
carded with the reagent cartridge.
In the same way described above, ABS/CHK well #6 provides 350 µL of ABS/CHK to
well #8 to be blended and diluted with 2450 µL. This second dilution supports the sec-
ond RMS System Check.
The RMS System Check is an adaptation of HABS hydration dilution test. In summary:
1. A dilution is made by the RMS using the RMS R3 Arm and RMS 2500 µL syringe pump.
2. The Flex with its primary RMS dilution is then shuttled from the RMS hydration station to
the RxL reagent tray (tray 1) and presented to the R1 Arm.
3. The R1 Arm using its 500 µL syringe pump aliquots five replicate RMS samples from
the Flex to five individual cuvettes.

Service Methods 387
4. The absorbance for each cuvette is calculated and reported out along with the mean
and SD for the five RMS (RIMS) tests.
5. The reported mean and SD are compared by the instrument software to allow limits and
reported as passing or failing the RMS System Check.
Note that the primary RMS dilution from which all five R1ARM aspiration and deliveries are
made is homogeneous in the sense that the five RMS tests are not five individual dilutions.
They are one dilution dispensed five times.
Troubleshooting 0
Accuracy
• Incorrect RMS coefficients.
• Coefficient requires mean adjustment.
• Incorrect Lot bottle value.
• Any RMS syringe pump defect.
• Any defect of the RMS pump reagent water supply or R3 probe tubing.
• Defective RMS tubing or tubing connections.
• Blockage of R3 probe.
• Vertical misalignment of the R3 probe.
• Defective optical filters (rare).
Precision
• Loose R1 tubing connections on pump panel.
• Defective R1 tubing.
• Loose R1 ultrasonic probe.
• Loose R1 tubing connection to R1 U/S assembly metal fitting.
• Loose R1 metal tubing fitting on the R1 U/S assembly.
• Drain water leakage into the measurement cuvettes.
Note that the nature of the homogenous RMS dilution precludes a precision problem being
caused by anything on the RMS. Typically the RMS mean and precision results should be
as good as or better than those reported for Reagent #1. If Reagent #1 reports nominal
System Check performance, but on the same report the RMS results are atypically higher,
the R1 pump and R1 U/S fluid tubing connections should be trimmed off and reattached. If
that does not correct the variation replacement of the R1, pump to probe tubing is recom-
mended. An example of typical versus atypical results is an R1 SD of 1.1 matched to an
RMS SD of 2.3 to 3.5.

388 Service Methods
W1BS/W2BS 21.4
Method Chemistry 0
Tab. 105 W1BS

1 R2ARM (H2O) 200 µl to vessel N
2 W1 (aspirate) Aspirate 200 µL of H2O from vessel N
W2 (dispense) Dispense 250 µL of Chemistry Wash to vessel N
3 R1ARM (H2O) 310 µl to cuvette Y
4 R2ARM (R3) 40 µl + (H2O) 110 µl to vessel Y
5 SAMPLE Transfer 50 µL of diluted ABS/CHK from vessel to Y
cuvette + (H2O) 40 µL
6 PHOTO READ 510/405 (ABS) or 600/510 (CHK) N
Tab. 106 W2BS

1 W1 (aspirate) Aspirate contents from vessel N
W1 (aspirate) Aspirate 250 µL from vessel N
1 W2 (aspirate) Aspirate 250 µL from vessel N
W2 (aspirate) Aspirate 250 µL from vessel N
3 R1ARM (H2O) 310 µl to cuvette Y
4 R2ARM (R3) 40 µl + (H2O) 110 µl Y
5 SAMPLE Transfer 50 µL of diluted ABS/CHK from vessel to cuvette + Y
(H2O) 40 µL
6 PHOTO READ 510/405 (ABS) or 600/510 (CHK) N
Method Specifics 0
Ensure SABS/SCHK, R1BS and R2BS are functioning properly.

Service Methods 389
• Photometric methods W1BS and W2BS (using ABS OR CHK Flex reagent cartridges).
• W1BS keyboard mapping: key: <ALT + GGT>, useful when scheduling individual.
• W2BS keyboard mapping: key: <ALT + GLUC>, useful when scheduling individual.
• Service methods for HM system check troubleshooting.
• One ABS/CHK Flex will support two W1BS and three W2BS System Checks.
• The absorbance for each cuvette is calculated and reported out along with the mean
and SD for HM tests.
• Replicates 1 and 2 are W1BS.
• Replicates 3, 4, and 5 are W2BS.
• The reported mean and SD are compared by the instrument software to allow limits and
reported as passing or failing the HM System Check.
• W1BS and W2BS Limits:
- Mean: 10 % of carton value ±4.0
- SD ≤ 1.6

390 List of Hazard IDs
22List of Hazard IDs 22-
There are no Hazard IDs in this document.


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Dimension®

Print No.: DCIN-B01.840.02.01.02 English

Part No.: 2014

Dimension® DCIN-B01.840.02.01.02 Page 2 of 390 © Siemens, 2014

1________ Preface ________________________________________________________ 14

2________ A Methods _____________________________________________________ 28

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 3 of 390 Dimension®

Dimension® DCIN-B01.840.02.01.02 Page 4 of 390 © Siemens, 2014

4________ C Methods _____________________________________________________ 86

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 5 of 390 Dimension®

5 _______ D Methods____________________________________________________ 135

6 _______ E Methods____________________________________________________ 148

Dimension® DCIN-B01.840.02.01.02 Page 6 of 390 © Siemens, 2014

Method Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

7________ F Methods ____________________________________________________ 162

8________ G Methods ____________________________________________________ 188

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 7 of 390 Dimension®

9 _______ H Methods____________________________________________________ 197

10 ______ I Methods ____________________________________________________ 213

Dimension® DCIN-B01.840.02.01.02 Page 8 of 390 © Siemens, 2014

11_______ L Methods ____________________________________________________ 226

12_______ M Methods ____________________________________________________ 241

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 9 of 390 Dimension®

13 ______ N Methods____________________________________________________ 263

14 ______ O Methods ___________________________________________________ 274

15 ______ P Methods____________________________________________________ 277

Dimension® DCIN-B01.840.02.01.02 Page 10 of 390 © Siemens, 2014

Method Specifics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299

16_______ R Methods ____________________________________________________ 313

17_______ S Methods ____________________________________________________ 315

18_______ T Methods ____________________________________________________ 319

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 11 of 390 Dimension®

High Intercept After Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

Dimension® DCIN-B01.840.02.01.02 Page 12 of 390 © Siemens, 2014

19_______ U Methods ____________________________________________________ 371

20_______ V Methods ____________________________________________________ 375

21_______ Service Methods _______________________________________________ 380

22_______ List of Hazard IDs ______________________________________________ 390

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 13 of 390 Dimension®

This chemistry troubleshooting guide provides information to assist you in troubleshooting

Dimension® DCIN-B01.840.02.01.02 Page 14 of 390 © Siemens, 2014

How to Use this Guide 1.1

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 15 of 390 Dimension®

Carryover Pairs 1.2

ACTM/ IBCT EZCR/ ADHL PCHE/ PHOS

Dimension® DCIN-B01.840.02.01.02 Page 16 of 390 © Siemens, 2014

Method Timing 1.3

Method Non-HM Methods HM Methods EXL LOCI

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 17 of 390 Dimension®

Method Non-HM Methods HM Methods EXL LOCI

Dimension® DCIN-B01.840.02.01.02 Page 18 of 390 © Siemens, 2014

Method Non-HM Methods HM Methods EXL LOCI

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 19 of 390 Dimension®

Method Non-HM Methods HM Methods EXL LOCI

Dimension® DCIN-B01.840.02.01.02 Page 20 of 390 © Siemens, 2014

Result Monitor 1.4

© Siemens, 2014 DCIN-B01.840.02.01.02 Page 21 of 390 Dimension®

2. If the same error occurs, run a QC sample for that method.

Result Monitor Maintenance Alert 0

The Result Monitoring Screen 0

Dimension® DCIN-B01.840.02.01.02 Page 22 of 390 © Siemens, 2014

ACCUMULATED RESULTS Fields

ZERO DATA Feature

1. Go to the Result Monitor screen for the method.

1 Preface ________________________________________________ 14

2 A Methods _____________________________________________ 28

4 C Methods _____________________________________________ 86

5 _ D Methods______________________________________________ 135

6 _ E Methods______________________________________________ 148

7 F Methods ____________________________________________ 162

8 G Methods ____________________________________________ 188

9 _ H Methods______________________________________________ 197

10 I Methods ______________________________________________ 213

11_ L Methods ______________________________________________ 226

12_ M Methods ______________________________________________ 241

13 N Methods______________________________________________ 263

14 O Methods _____________________________________________ 274

15 P Methods______________________________________________ 277

16_ R Methods ______________________________________________ 313

17_ S Methods ______________________________________________ 315

18_ T Methods ______________________________________________ 319

19_ U Methods ______________________________________________ 371

20_ V Methods ______________________________________________ 375

21_ Service Methods _________________________________________ 380

22_ List of Hazard IDs ________________________________________ 390