Creatinine plus ver.2

Catalog Number: 03263991190

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of the creatinine concentration in human serum, plasma, and urine on COBAS INTEGRA systems.

STORAGE AND STABILITY

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction direction Increase
Wavelength A/B 552/659 nm
Calc. first/last 35/65

PIPETTING PARAMETERS

 Serum, plasma Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL
Urine Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL

 Serum, plasma Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL
Urine Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL

COBAS INTEGRA 800 test definition

 Calibration

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction direction Increase
Wavelength A/B 552/659 nm
Calc. first/last 46/98
Serum, plasma
Reaction mode R1-S-SR
Unit µmol/L
Urine
Reaction mode D-R1-S-SR
Predilution factor 20
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

 Serum, plasma Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL
Urine Diluent (H2O)
R1 77 µL
Sample 2 µL 5 µL
SR 38 µL
Total volume 122 µL

 Calibration

CALIBRATION

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Serum/plasma

SPECIFIC PERFORMANCE DATA

PRECISION

Serum/plasma

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (1 ALIQUOT PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (1 ALIQUOT PER RUN, 1 RUN PER DAY, 10 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Creatinine values for human serum, plasma and urine samples obtained on a COBAS INTEGRA 400 analyzer using the COBAS INTEGRA Creatinine plus ver.2 reagent (y) were compared with those determined using the commercially available Creatinine plus reagent on a Roche/Hitachi 917 analyzer (x).

MAZZACHI BC, PEAKE MJ, EHRHARDT V. REFERENCE RANGE AND METHOD COMPARISON STUDIES FOR ENZYMATIC AND JAFFÉ CREATININE ASSAYS IN PLASMA AND SERUM AND EARLY MORNING URINE. CLIN LAB 2000;53-55.

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.