Creatinine plus ver.2

Catalog Number: 05168589190

SYSTEM INFORMATION

CREA2: ACN 8452 (serum and plasma)

INTENDED USE

In vitro assay for the quantitative determination of creatinine in human serum, plasma and urine on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

CREP2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours
Diluent NaCl 9 %
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 2-Point End
Reaction time / Assay points 10/22-38
Wavelength (sub/main) 700/546 nm
Reaction direction Increase
Units µmol/L (mg/dL, mmol/L)
Reagent pipetting Diluent (H2O)
R1 77 µL
R3 38 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 5 µL 15 µL 135 µL
Increased 4 µL

CALIBRATION

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

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency Blank calibration- after 4 weeks during shelf life2-point calibration- after reagent lot change- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

BLANK CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the 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 (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS 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 (3 ALIQUOTS 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 Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

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.