Catalog Number: 06600239190
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems.
|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|
cobas c 311 test definition
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 frequency||▪after reagent lot change and after 90 days▪as required following quality control procedures|
Limit of Blank, Limit of Detection and Limit of Quantitation
Representative performance data on the analyzers are given below.
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:
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).