A clinical trial for therapeutic drug monitoring using microchip-based fluorescence polarization immunoassay |
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| Authors: | Tachi Tomoya Hase Tetsunari Okamoto Yukihiro Kaji Noritada Arima Takeshi Matsumoto Hiroyuki Kondo Masashi Tokeshi Manabu Hasegawa Yoshinori Baba Yoshinobu |
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| Affiliation: | (1) Department of Applied Chemistry, Graduate School of Engineering, Nagoya University, Nagoya 464-8603, Japan;(2) Department of Respiratory Medicine, Graduate School of Medicine, Nagoya University, Nagoya 466-8560, Japan;(3) FIRST Research Center for Innovative Nanobiodevices, Nagoya University, Nagoya 464-8603, Japan;(4) Department of Medical Technique, Nagoya University Hospital, Nagoya 466-8560, Japan;(5) National Institute of Advanced Industrial Science and Technology (AIST), Takamatsu 761-0395, Japan; |
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| 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. |
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