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. 2013

Eric Dailly, and François Fraissinet, and Guillaume Deslandes, and Régis Bouquié, and Pascale Jolliet
Clinical Pharmacology Department, Hôtel Dieu, CHU de Nantes, France. eric.dailly@chu-nantes.fr

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

UI MeSH Term Description Entries
D007118 Immunoassay A technique using antibodies for identifying or quantifying a substance. Usually the substance being studied serves as antigen both in antibody production and in measurement of antibody by the test substance. Immunochromatographic Assay,Assay, Immunochromatographic,Assays, Immunochromatographic,Immunoassays,Immunochromatographic Assays
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D016014 Linear Models Statistical models in which the value of a parameter for a given value of a factor is assumed to be equal to a + bx, where a and b are constants. The models predict a linear regression. Linear Regression,Log-Linear Models,Models, Linear,Linear Model,Linear Regressions,Log Linear Models,Log-Linear Model,Model, Linear,Model, Log-Linear,Models, Log-Linear,Regression, Linear,Regressions, Linear
D016231 Fluorescence Polarization Immunoassay Fluoroimmunoassay where detection of the hapten-antibody reaction is based on measurement of the increased polarization of fluorescence-labeled hapten when it is combined with antibody. The assay is very useful for the measurement of small haptenic antigens such as drugs at low concentrations. Immunoassay, Fluorescence Polarization,Polarization Fluoroimmunoassay,Fluorescence Polarization Immunoassays,Fluoroimmunoassay, Polarization,Fluoroimmunoassays, Polarization,Immunoassays, Fluorescence Polarization,Polarization Fluoroimmunoassays,Polarization Immunoassay, Fluorescence,Polarization Immunoassays, Fluorescence
D016903 Drug Monitoring The process of observing, recording, or detecting the effects of a chemical substance administered to an individual therapeutically or diagnostically. Monitoring, Drug,Therapeutic Drug Monitoring,Drug Monitoring, Therapeutic,Monitoring, Therapeutic Drug
D017334 Teicoplanin Lipoglycopeptide antibiotic from Actinoplanes teichomyceticus active against gram-positive bacteria. It consists of five major components each with a different fatty acid moiety. Teichomycin,Targocid,Teichomycin A2

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