Catalog Number: 04490991190
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of quinidine in 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|
|Do not freeze.|
Specimen collection and preparation
Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.
Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of quinidine in normal human serum.
|Calibrators||S1-6: Preciset TDM II Calibrators|
|Calibration frequency||6-point calibration- after reagent lot change- every 6 weeks- as required following quality control procedures|
0.11-8 µg/mL (0.34-24.6 µmol/L)
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 a modified NCCLS EP5-A protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.
|Compound||Concentration tested (µg/mL)||%Cross-reactivity|
|ND = not detectable|