Creatinine Jaffé Gen.2 - Urine

Catalog Number: 04810716190

SYSTEM INFORMATION

Test CRJ2U; test ID 0-546 on COBAS INTEGRA 400 plus systems; test ID 0-346 on COBAS INTEGRA 800 systems

INTENDED USE

In vitro test for the quantitative determination of creatinine in urine on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 15-25 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 8 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 8 weeks

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction direction Increase
Wavelength A/B 512/583 nm
Calc. first/last 40/49
Reaction mode D-R1-S-SR
Predilution factor 25
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 13 µL 71 µL
Sample 10 µL 20 µL
SR 17 µL 16 µL
Total volume 147 µL

Diluent (H2O)
R1 13 µL 41 µL
Sample 10 µL 30 µL
SR 17 µL 36 µL
Total volume 147 µL

COBAS INTEGRA 800 test definition

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Kinetic
Reaction direction Increase
Wavelength A/B 512/583 nm
Calc. first/last 55/70
Reaction mode D-R1-S-SR
Predilution factor 25
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 13 µL 41 µL
Sample 10 µL 30 µL
SR 17 µL 36 µL
Total volume 147 µL

CALIBRATION

Traceability: This method has been standardized against ID/MS.a)

Calibrator Calibrator f.a.s.Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval COBAS INTEGRA 400 plus analyzers: Each cobas c pack, every 7 days, and as required following quality control proceduresCOBAS INTEGRA 800 analyzers: Each lot and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.027-32.5 mmol/L (0.31-367 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 20 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

Creatinine values for human urine samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Creatinine Jaffé Gen.2 reagent (y) were compared with those determined using the commercially available reagent for creatinine on an alternative manufacturer’s clinical chemistry system (x). Samples were measured in duplicate. Sample size (n) represents all replicates.