Evaluation of the QMS® Teicoplanin Immunoassay (ThermoFisher Scientific) on Cobas® 8000 System (Roche Diagnostics) and comparison to fluorescence polarization immunoassay for the determination of teicoplanin concentrations in human plasma

J Clin Lab Anal. 2013 Mar;27(2):96-8. doi: 10.1002/jcla.21567. Epub 2013 Feb 1.

Abstract

Background: The performances of the QMS(®) Teicoplanin immunoassay recently developed on Cobas(®) 6000/8000 systems were evaluated and compared to a fluorescence polarization immunoassay (FPIA) [Teicoplanin Innofluor(®) Assay (Thermo Fisher Scientific, Indianapolis, IN)] on FLX analyzer (Abbott Laboratories, Abbott Park, IL)].

Methods: The validation was performed according to the Cofrac (French Accreditation Committee) document SH GTA 04. For the comparison, 48 plasma samples were analyzed by FPIA and QMS assays.

Results: The QMS assay is accurate (intra assay and inter assay inaccuracy ≤ 2.4%) and precise (intra assay and inter assay imprecision ≤ 10.2%). A linear relationship [QMS = 1.0319 × FPIA - 2.8518, r(2) = 0.9246 (P < 0.001)] between FPIA and QMS was found. In the Bland-Altman plots, no systematic bias was found even if QMS results trends to be lower (mean of the ratio QMS concentration/FPIA concentration = 0.91).

Conclusion: These results between QMS and FPIA are consistent, which indicates that QMS(®) Teicoplanin immunoassay on Cobas(®) 8000 System is an alternative to FPIA.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Drug Monitoring / methods*
  • Drug Monitoring / standards*
  • Fluorescence Polarization Immunoassay / methods*
  • Humans
  • Immunoassay / methods*
  • Linear Models
  • Reproducibility of Results
  • Teicoplanin / blood*

Substances

  • Teicoplanin