Tina-quant Cystatin C Gen.2

Catalog Number: 06600239190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 8 weeks

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition

C 311 TEST DEFINITION

 501 TEST DEFINITION

 502 TEST DEFINITION

CALIBRATION

Traceability: This method has been standardized against ERM-DA471/IFCC reference material.

Calibrators S1: H2OS2-6: C.f.a.s. Cystatin C
Multiply the lot-specific C.f.a.s. Cystatin C calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:
S1: 0 S4: 0.388
S2: 0.107 S5: 0.698
S3: 0.192 S6: 1
Calibration mode Spline
Calibration Full calibration
Calibration frequency ▪after reagent lot change and after 90 days▪as required following quality control procedures

6-POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION

FULL CALIBRATION

CALIBRATION FREQUENCY

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.40-6.80 mg/L

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation

SPECIFIC PERFORMANCE DATA

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

PRECISION

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

REPEATABILITY AND INTERMEDIATE PRECISION WERE DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Cystatin C values for human serum samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) using the Roche/Hitachi CYSC2 reagent were compared with those determined using the Diazyme reagent on a Roche/Hitachi MODULAR P analyzer (x).