title: A clinical trial for therapeutic drug monitoring using microchip-based fluorescence polarization immunoassay.
abstract: Microchip analysis is a promising method for therapeutic drug monitoring. This led us to evaluate a microchip-based fluorescence polarization immunoassay (FPIA) system for point-of-care testing on patients being treated with theophylline. The sera were collected from 20 patients being treated with theophylline. Fluorescence polarization was measured on the microchip and theophylline concentrations in serum were obtained. Regression analysis of the correlations was done between the results given by the microchip-based FPIA and the conventional cloned enzyme donor immunoassay (CEDIA), and between the results given by the microchip-based FPIA and the conventional particle-enhanced turbidimetric inhibition immunoassay (PETINIA). We successfully carried out a quantitative analysis of theophylline in serum at values near its therapeutic range in 65 s. The results obtained by the microchip-based FPIA correlated well with CEDIA and PETINIA results; the correlation coefficients (R(2)) were 0.986 and 0.989, respectively. The FPIA system is a simple and rapid method for point-of-care testing of drugs in serum, and its accuracy is the same as the conventional CEDIA and PETINIA. It is essential to use real samples from patients and to confirm good correlations with conventional methods for a study on the realization of microchip.
authors.affiliation: Department of Applied Chemistry, Graduate School of Engineering, Nagoya University, Nagoya 464-8603, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Tachi
authors.forename: Tetsunari
authors.initials: T
authors.lastname: Hase
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Okamoto
authors.forename: Noritada
authors.initials: N
authors.lastname: Kaji
authors.forename: Takeshi
authors.initials: T
authors.lastname: Arima
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Matsumoto
authors.forename: Masashi
authors.initials: M
authors.lastname: Kondo
authors.forename: Manabu
authors.initials: M
authors.lastname: Tokeshi
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Baba
mesh_terms: D002986:Clinical Trials as Topic; D016903:Drug Monitoring; D016231:Fluorescence Polarization Immunoassay; D006801:Humans; D046208:Microchip Analytical Procedures; D013806:Theophylline / Q000008:administration & dosage / Q000032:analysis* / Q000097:blood*
chemical_list: D013806:Theophylline