摘要
目的考察荧光偏振免疫(FPIA)法测定环孢素A(CsA)血药浓度的可行性及本实验室条件下CsA的治疗药物监测质量控制水平。方法以标准质控为样本,考察FPIA法测定CsA血药浓度的方法学性质,对本实验室2008年质控数据进行统计分析。结果方法低、中、高浓度回收率为92.83%～100.43%,RSD为2.49%～6.12%;本院2008年度随行质控低、中、高浓度RSD分别为5.85%,5.41%,4.95%,符合中国药典要求。质控图基本符合正态分布,存在一定程度的趋势性变化。结论 FPIA法具有良好的准确度和精密度,在长期的检测中稳定性较好,适合临床开展治疗药物监测,但应建立合理质控体系。
Objective To study the feasibility of fluorescence polarization immunoassay（FPIA） for detecting the blood concentration of cyclosporin A（CsA） and to investigate the quality control level of the therapeutic drug monitoring（TDM） under laboratory conditions.Methods With the standard control as the sample,the methodological character of FPIA method to detect CsA under this lab was investigated.The quality control data in year 2008 were statistically analyzed.Results The average recovery rates of low,middle and high concentrations were between 92.83%-100.43% and RSD was between 2.49%-6.12%.Low,middle and high RSD for the accompanying quality control data in year 2008 was 5.85%,5.41% and 4.95% respectively,which according with the requirement of Chinese Pharmacopoeia.The quality control chart basically fitted the normal distribution with the tendency change in some extent.Conclusion FPIA method has good accuracy,precision and long-term stability,which is suitable for clinical TDM,but the reasonable quality control system should be set up firstly.
出处
《中国药业》
CAS
2010年第22期20-21,共2页
China Pharmaceuticals
基金
江苏省卫生厅医学科技发展基金临床药学研究科技项目
项目编号:P200705
关键词
荧光偏振免疫法
环孢素A
治疗药物监测
质量控制
fluorescence polarization immunoassay（FPIA）
cyclosporine A
therapeutic drug monitoring（TDM）
quality control
