Catalog Number: 03005771322
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of α1‑antitrypsin 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:||12 weeks|
|cobas c 311 test definition|
|Assay type||2‑Point End|
|Reaction time / Assay points||10 / 6-24|
|Wavelength (sub/main)||700/340 nm|
|Units||g/L (µmol/L, mg/dL)|
|Reagent pipetting||Diluent (H2O)|
|Calibrators||S1: H2OS2: C.f.a.s. Proteins|
|Multiply the lot-specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:|
|S2: 0.233||S5: 1.56|
|S3: 0.467||S6: 2.28|
0.2‑6.0 g/L (3.68‑110.4 µmol/L, 20‑600 mg/dL)
Lower detection limit of the test
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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:
α1‑Antitrypsin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).