用酶增强免疫分析法监测他克莫司血药浓度的质控评估

目的：评价酶增强免疫分析法（EMIT）监测患者全血中他克莫司浓度的质量,建立并改进他克莫司血药浓度监测的质量控制方法。方法：以标准质控为样本,进行预防性质量控制和室内质量控制研究。对2008年血药浓度监测中随行质控样本的测定值做回顾性研究并进行统计学分析,建立新的质控规则。结果：他克莫司低、中、高浓度（4.3、8.9、18.0 ng/ml）2009年质控样本的日内、日间RSD为1.8%-11.2%,平均回收率为90.5%-114.0%,符合《中华人民共和国药典》生物样品测定的要求。2008年质控样本的低、中、高浓度（3.8、7.5、15.0 ng/ml）的随行质控RSD分别为21.8%、14.2%和15.5%,适合本单位的质控规则为12S/13S/22S/41S/7tr。结论：EMIT法准确度和精密度良好,是一种较理想的他克莫司血药浓度测定方法,但影响因素较多,特别是温度对其影响较大,因此必须做好质量控制。

Evaluation of quality control for therapeutic drug monitoring of tacrolimus by enzyme-multiplied immunoassay technique

Objective:To evaluate the quality of enzyme-multiplied immunoassay technique(EMIT) for therapeutic drug monitoring(TDM) of tacrolimus,establish and improve the quality control method for TDM of tacrolimus.Methods:Researches on prospective and internal quality control were carried out on standard quality control samples.Results of TDM of control samples in 2008 were retrospectively studied and statistically analyzed.A new quality control rule was established.Results:The inter- and intra-day RSD of low, middle and high concentrations(4.3,8.9,18.0 ng/ml) of tacrolimus,which was quality control sample of batch number 7190,ranged from 1.8%-11.2%,and the average recovery rates were in the range of 90.5%-114.0%.This was up to the requirements of biological sample determination in Chinese Pharmacopoeia.RSD of the low, middle and high concentrations(3.8,7.5,15.0 ng/ml) of control samples in 2008 (the batch number was 2250) were 21.8%,14.2% and 15.5%,respectively.The new quality control rule was 1_(2S)/1_(3S)/2_(2S)/4_(1S)/7_(tr).Conclusion:EMIT method is suitable for TDM of tacrolimus with good accuracy and precision. However, it is susceptible to several factors, especially temperature.Therefore, the quality control must be done carefully.