荧光偏振免疫法在地高辛血药浓度监测中的质控评价

Evaluation of Blood Drug Monitoring Method for Digoxin by Fluorescence Polarization Immunoassay

目的评价荧光偏振免疫分析法(FPIA)在地高辛血药浓度监测中的稳定性。方法对2007年及2008年的血药浓度监测中随行质控样本测定值进行统计学分析。结果两年中测得的低、中、高质控样本的平均回收率为101.31%,98.67%,100.54%,相对百分偏差(RSD%)为4.96%,6.49%,7.13%,所测定质控样本RSD<9%,符合中国药典对生物样品测定RSD%的规定范围。结论在加强质量管理的基础上,FPIA方法长期临床应用准确、稳定、可靠,适用于临床治疗中血药浓度监测。

Objective To evaluate the method stability for monitoring Digoxin by fluorescence polarization immunoassay （FPIA）. Methods Statistical analysis was conducted on Digoxin control data determined together with the patient samples of 2007 and 2008. Results The mean recoveries of the low,medium and high control samples were 101.31%,98.67% and 100.54%,with RSD% of 4.96 %,6.49% and 7.13%, respectively. RSDs were all less than 9% ,and accorded with the requirement for biological sample determination in the Chinese phamaacopoeia,which should be less than 15 %. Condusion Determination of Digoxin by FPIA is a comparatively accurate and stable method, and can be used for therapeutic drug monitoring.