Catalog Numbers: 04490932190, 05108411190
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of phenytoin 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:Do not freeze.||12 weeks|
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 phenytoin in normal human serum.
|Calibrators||S1-6: Preciset TDM I calibrators|
|Calibration frequency||6-point calibration- after reagent lot change- every 6 weeks- as required following quality control procedures|
0.8-40 µg/mL (3.2-158.4 µmol/L)
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-T2 protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a cobas c 501 analyzer.
The following compounds were tested for cross reactivity.