荧光偏振免疫法在环孢素A血药浓度监测中的质控评价

目的:评价荧光偏振免疫分析法(FPIA)在环孢素A(CsA)血药浓度监测中的稳定性.方法:对2003年一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:一年中测得的低、中、高质控样本的平均回收率及相对百分偏差(RSD%)分别为99.2%,99.8%,98.52%,8.21%,5.27%,5.15%,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方法在长期的环孢素A血药浓度测定中较准确,且稳定性良好,适用于临床治疗中血药浓度监测.

Evaluation of blood drug monitoring method for CsA by FPIA

OBJECTIVE To evaluate the method stability for monitoring of CsA by FPIA. METHODS To make a statistical analysis of CsA control data determined together with the patient samples last year. RESULTS The mean recoveries of the low, medium and high control samples were 99. 2%,99. 8% ,98. 52%, RSD% were 8. 21%, 5.27%,5. 15% respectively. RSDs were all less than 9% ,and accorded with the requirement for biological sample determination in the Chinese pharmacopoeia, which should be less than 15%. CONCLUSION Determination of CsA by FPIA is a comparatively accurate and stable method,and can be used for therapeutic drug monitoring.