title: Performance of a fluorescence polarization immunoassay system evaluated by therapeutic monitoring of four drugs.
abstract: Fluorescence polarization immunoassays (FPIA) for amikacin, gentamicin, quinidine, and theophylline (supplied by Roche Diagnostic Systems, made using a Cobas Fara centrifugal analyzer) were evaluated and compared with widely used monitoring analysis methods. For each drug, the between-assay imprecision was ascertained by calibration on the day of assay and by a stored calibration curve made at the beginning of the study. The precision of the amikacin and theophylline assays was acceptable [total coefficient of variation (CV) less than 7.5%] at all concentrations tested for each calibration mode. Imprecision of quinidine and gentamicin assays was significant at low concentrations (1.9 mg/L): total CV = 9.0% for quinidine assessed with stored calibration curve and total CV greater than 8.5% for gentamicin measured with the two calibration modes. The calibration curves for all four assays had a good stability (greater than 30 days). Linear regression analysis demonstrated close agreement between the FPIA (y) and the following comparative techniques (x): Abbott TDx assay for amikacin and gentamicin (r = 0.988, r = 0.974, respectively); Stratus fluorometric enzyme immunoassay for quinidine (r = 0.979); and EMIT Syva assay for theophylline (r = 0.993). It is concluded that fluorescence polarization immunoassay is a rapid and reliable method for the therapeutic monitoring of the four drugs tested. Moreover, the use of reagents on an instrument that can be implemented for a wide range of chemistries has significant advantages and cost benefits over dedicated instruments.
authors.affiliation: Institute of Laboratory Medicine, University of Padova, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Zaninotto
authors.forename: S
authors.initials: S
authors.lastname: Secchiero
authors.forename: C D
authors.initials: CD
authors.lastname: Paleari
authors.forename: A
authors.initials: A
authors.lastname: Burlina
mesh_terms: D000583:Amikacin / Q000097:blood; D002138:Calibration; D016903:Drug Monitoring / Q000379:methods*; D005069:Evaluation Studies as Topic; D016231:Fluorescence Polarization Immunoassay; D005839:Gentamicins / Q000097:blood; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011802:Quinidine / Q000097:blood; D012015:Reference Standards; D013806:Theophylline / Q000097:blood
chemical_list: D005839:Gentamicins; D004364:Pharmaceutical Preparations; D000583:Amikacin; D013806:Theophylline; D011802:Quinidine