Tina-quant Cystatin C Gen.2

Catalog Number: 06600263190

SYSTEM INFORMATION

CYSC2: ACN 8109

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
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

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

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:

CALIBRATION MODE

CALIBRATION

FULL CALIBRATION

CALIBRATION FREQUENCY

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

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 was determined using human samples and controls in an internal protocol (n = 21, 1 run). Intermediate precision was 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 WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL (N = 21, 1 RUN). INTERMEDIATE PRECISION WAS 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 701 analyzer (y) were compared with those determined using the same 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,