苯妥英荧光偏振免疫测定试剂盒的研制

Development of phenytoin reagent pack for fluorescence polarization immunoassay

荧光偏振免疫分析法(FPIA)已在我国临床药物测定中应用,但因测定试剂盒依赖进口、价格昂贵等而使其发展受限制.我们在开发成功庆大霉素、丁胺卡那霉素试剂盒的基础上,通过合成试剂盒重要组成之一的荧光素标记苯妥英,研制了苯妥英的 FPIA 试剂盒.经考核,本试剂盒的各项分析指标均符合临床药物测定要求,与进口同类试剂盒及国产放免测定试剂盒的结果比较,相关系数分别为0.994和0.970。

A domestic reagent pack,used in the fluorescence polariza- tion immunoassay for phenytoin,was developed by preparing the tracer of fluoreseein labeled phenytoin and its antiserum.This pack can be used in the Abbott TDx system.Analytical recovery of phenytoin from serum averaged 102%,with sensitivity of 0.6mg/L.CVs within and between-run were all≤ 7.0%.Commonly co-administered drugs did rtot affect the assay results.This pack was compared with the Abbott pack and a radioimmunoassay pack, yielding correlation coefficients of 0.994 and 0.970,respectively.