TRACEABILITY and UNCERTAINTY 5 r

COBAS INTEGRA® / cobas c 111 – Precipath PUC

Cat. No. 03 121 291 122

Roche Diagnostics GmbH November 2012

Routine Method Reference Method Reference Material Selected Measurement Assigned Value Uncertainty 1 Unit
Roche/Integra Systems Procedure

A1MG2 nephelometric method 107 10.3 mg/L

Microglobulin alpha 1
3560 343 nmol/L
immunoturbidimetric Gen. 2
4
ALBT2 ERM-DA470k/IFCC 122 4.76 mg/L
Albumin
12.2 0.476 mg/dL
immunoturbidimetric. Gen. 2
urine
4
ALBT2 ERM-DA470k/IFCC 127 2.82 mg/L
Albumin
12.7 0.282 mg/dL
immunoturbidimetric. Gen. 2 CSF
Integra 800
4
ALBT2 ERM-DA470k/IFCC 120 2.42 mg/L
Albumin
12.0 0.242 mg/dL
immunoturbidimetric Gen. 2 CSF
Integra 400
3
CREP2 ID-MS 4.30 0.122 mmol/L
Creatinine
48.6 1.38 mg/dL
plus ver. 2 urine
only for Integra
3
CREP2 ID-MS 4.47 0.104 mmol/L
Creatinine
50.5 1.18 mg/dL
plus ver. 2 urine
only for cobas c 111
3
CREJ2 ID-MS 4.36 0.0516 mmol/L
Creatinine
49.3 0.583 mg/dL
Jaffé Gen.2 urine

Integra _cobas c 111_PP PUC Ver 3 Page 1 of 2

TRACEABILITY and UNCERTAINTY 5 r
COBAS INTEGRA® / cobas c 111 – Precipath PUC
Cat. No. 03 121 291 122

Roche Diagnostics GmbH November 2012

Routine Method Reference Method Reference Material Selected Measurement Assigned Value Uncertainty 1 Unit
Roche/Integra Systems Procedure

IGA CRM 470 2 0.393 0.0204 g/L

Immunoglobulin A
39.3 2.04 mg/dL
immunoturbidimetric sensitive

IGM CRM 470 2 0.214 0.0329 g/L

Immunoglobulin M
21.4 3.29 mg/dL
immunoturbidimetric sensitive

TPUC3 Internal standard 1360 66.6 mg/L

Total protein urine/CSF material
136 6.66 mg/dL
turbidimetric Gen. 3 urine

TPUC3 Internal standard 1490 74.0 mg/L

Total protein urine/CSF material
149 7.40 mg/dL
turbidimetric Gen. 3 CSF

1
This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM:1993). For the estimation of
the single standard uncertainties normal distribution of the measurement results is assumed; the level of confidence of the expanded uncertainty is about 95% with the coverage
factor k=2 (analogue to the 2sd of the standard uncertainty).
2
CRM = Certified Reference Material, European
3
ID-MS = Isotope Dilution – Mass Spectrometry
4
ERM = European Reference Materials
5
Unless otherwise noted, the assigned values and uncertainties are valid for Integra and c 111 provided that the method is available on that analyzer.

Integra _cobas c 111_PP PUC Ver 3 Page 2 of 2