Catalog Number: 05950848190
CER: ACN 8707
In vitro test for the quantitative determination of ceruloplasmin 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:||4 weeks|
|On‑board on the Reagent Manager:||24 hours|
|cobas c 701/702 test definition|
|Assay type||2‑Point End|
|Reaction time / Assay points||10/19‑33|
|Wavelength (sub/main)||700/340 nm|
|Units||g/L (µmol/L, mg/dL)|
|Reagent pipetting||Diluent (H2O)|
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
|Calibrators||S1: H2OS2-S6: C.f.a.s. PAC|
|Multiply the lot‑specific C.f.a.s. PAC calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:|
|S2: 0.600||S5: 3.20|
|S3: 1.25||S6: 4.00|
|Calibration frequency||Full calibration• after reagent lot change• as required following quality control procedures|
0.03‑1.4 g/L (0.22‑10.44 µmol/L, 3‑140 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:
Ceruloplasmin values for human serum and plasma 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).