Creatinine Jaffé Gen.2

Catalog Number: 06407137190

SYSTEM INFORMATION

CREJ2: ACN 8690 (Rate blanked, compensated, serum and plasma)

INTENDED USE

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

STORAGE AND STABILITY

 CREJ2
Shelf life at 15‑25 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 7 days
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 Rate A
Reaction time / Assay points 10/23-29 -12-18 (STAT 5 / 11-17)
Wavelength (sub/main) 570/505 nm
Reaction direction Increase
Units µmol/L (mg/dL, mmol/L)
Reagent pipetting Diluent (H2O)
R1 13 µL 77 µL
R3 (STAT R2) 17 µL 30 µL
Sample volumes Sample Sample dilution
Sample Diluent(NaCl)
Normal 10 µL
Decreased 10 µL 20 µL 80 µL
Increased 10 µL

Enter the correction value for the non-specific protein reaction as the instrument factor y = ax + b for mg/dL or for µmol/L, where a = 1.0 and b = -0.3 (mg/dL) or a = 1.0 and b = -26 (µmol/L).

CALIBRATION

 

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

PLEASE NOTE: IN CASE OF LONG BATCHES A FULL RECALIBRATION IS REQUIRED EVERY ~150 DETERMINATIONS PER ROTOR.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma

LOWER LIMITS OF MEASUREMENT

Limit of Blank and Limit of Detection

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.Serum/plasma: Repeatability (n = 21), intermediate precision (3 aliquots per run, 1 run per day, 21 days);Urine: Repeatability (n = 21), intermediate precision (3 aliquots per run, 1 run per day, 10 days). The following results were obtained:

RESULTS FOR INTERMEDIATE PRECISION IN URINE AND FOR STAT APPLICATIONS WERE OBTAINED ON THE MASTER SYSTEM 501 ANALYZER.

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).

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.