Catalog Number: 05967104190
In vitro test for the quantitative determination of ethanol in human serum, plasma and urine 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|
|On‑board on the Reagent Manager:||24 hours|
|cobas c 701/702 test definition|
|Assay type||2‑Point End|
|Reaction time / Assay points||10/25‑32 (STAT 6/11‑18)|
|Wavelength (sub/main)||700/340 nm|
|Units||mmol/L (g/L, mg/dL)|
|Reagent pipetting||Diluent (H2O)|
|R3 (STAT R2)||50 µL||–|
|Sample volumes||Sample||Sample dilution|
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
|Calibrators||S1: H2OS2: Ammonia/Ethanol /CO2 Calibrator|
|Calibration frequency||2‑point calibration- after cobas c pack change- after 6 weeks on board- as required following quality control procedures|
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:
Ethanol values for human serum, plasma and urine 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).