cobas c 111 analyzer

Within-Run Precision Guidelines

COBAS and LIFE NEEDS ANSWERS are trademarks of Roche.

©2012-2014 Roche

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www.usdiagnostics.roche.com
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2461-04-1014
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Revision History
Revisions to this document are provided by Roche when necessary. No part of this document may be reproduced
in any form or by any means without prior written consent.

Publication Reference Number Date Revision purpose

2461-00-0907
September 2007 Document creation
Version 0

2461-01-1207
December 2007 Added new clinical chemistries and specific proteins.
Version 1

2461-02-0508
May 2008 Added new clinical chemistries and specific proteins
Version 2

2461-03-0314
March 2014 Added Calcium Gen.2
Version 3

2461-04-1014 Deleted Bilirubin direct and Calcium.

October 2014
Version 4 Added Bilirubin Total, Gen.3

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 cobas c 111 analyzer Within Run Precision Guidelines
Clinical Chemistry
How to use these guidelines:

Where the SD and CV% information is provided, the SD specification is used to determine pass/fail criteria
if the actual sample concentration is below the stated sample concentration in the table. If the actual sample
concentration is equal to or above the stated sample concentration in the table, the CV% specification is used
to determine pass/fail criteria.

Sample %CV
Clinical Chemistry SD
Concentration Guideline
Albumin BCG < 0.07 g/dL 3.5 g/dL <2
Alk Phos/IFCC gen. 2 < 2 U/L 100 U/L <2
ALT < 0.9 U/L 30 U/L <3
ALT/P-5-P < 1.0 U/L 35 U/L <3
Ammonia < 6 μg/dL 85 μg/dl <5
p-Amylase/EPS (serum) < 1 U/L 50 U/L <2
t-Amylase/EPS (serum/plasma) < 2 U/L 100 U/L <2
AST < 0.9 U/L 30 U/L <3
AST/P-5-P < 1.0 U/L 35 U/L <3
Bilirubin, Total-Special < 0.03 mg/dL 1.0 mg/dL < 2.5
Bilirubin, Total Gen.3 < 0.05 mg/dL 0.99 mg/dL <5
Calcium Gen.2 (serum/plasma/urine) < 0.16 mg/dL 8.8 mg/dL <2
Cholesterol/HP Gen 2 < 3.87 mg/dL 201 mg/dL <2
CK Liquid < 3 U/L 140 U/L <2
CK-MB < 0.8 U/L 25 U/L <3
CO2-L < 0.36 mmol/L 12 mmol/L <3
Creatinine Plus ver 2-serum < 0.03 mg/dL 0.9 mg/dL <3
Creatinine Plus ver 2-urine < 0.85 mg/dL 28 mg/dL <3
Creatinine/Jaffe, rate blanked, compensated (serum/plasma) < 0.03 mg/dL 0.9 mg/dL <3
Creatinine/Jaffe, rate blanked, compensated (urine) < 0.85 mg/dL 28 mg/dL <3
GGT ver 2 (serum/plasma) < 0.8 U/L 40 U/L <2
Glucose ver 2 (serum/plasma) < 1.4 mg/dL 70 mg/dL <2
HDL-C plus Gen 3 < 1.16 mg/dL 38.7 mg/dL <3
Iron2 < 3.02 µg/dL 150.4 µg/dL <2
Lactate-Enzymatic < 0.36 mg/dL 19.8 mg/dL <2
LDH < 4 U/L 200 U/L <2
LDL-C Plus Gen 2 < 3.9 mg/dL 155 mg/dL <3
Lipase (colorimetric) < 1.2 U/L 60 U/L <2
Magnesium < 0.05 mg/dL 1.7 mg/dL <2
Phosphate ver 2 < 0.06 mg/dL 2.70 mg/dL <2
Total Protein < 0.13 g/dL 6.6 g/dL <2
Triglycerides < 4.4 mg/dL 203.6 mg/dL <2
Urea/BUN (serum/plasma) < 0.48 mg/dL 23.2 mg/dL <2
Uric Acid (serum/plasma) < 0.1 mg/dL 7.1 mg/dL <2

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cobas c 111 analyzer Within Run Precision Guidelines
Ion Selective Electrodes (ISE)

Sample %CV
Clinical Chemistry SD
Concentration Guideline
Chloride (serum/plasma) < 2.5 mmol/L 89 mmol/L < 1.5
Chloride (urine) < 3.5 mmol/L 89 mmol/L < 6.0
Potassium (serum/plasma) < 0.15 mmol/L 6.0 mmol/L < 1.2
Potassium (urine) < 1.0 mmol/L 10.0 mmol/L < 5.0
Sodium (serum/plasma) < 3.0 mmol/L 110.0 mmol/L < 1.0
Sodium (urine) < 6.0 mmol/L 120.0 mmol/L < 5.0

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Specific Proteins

Sample %CV
Specific Proteins SD
Concentration Guideline
Albumin TQ (urine) < 0.8 mg/L 20 mg/L <4
CRP/Latex < 0.02 mg/dL 0.5 mg/dL <4
CRP/High Sensitivity < 0.004 mg/dL 0.1 mg/dL <4
HbA1c (whole blood) < 0.25% HbA1c 5% HbA1c <4
HbA1c (hemolysate) < 0.25% HbA1c 5% HbA1c <4

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