酶增强免疫分析法测定环孢素A和他克莫司血药浓度的质量控制

Enzyme-multiplied immunoassay technique determination of Cyclosporine A and Tacrolimus blood concentration of quality control

目的 评价和分析酶增强免疫分析法（EMIT）监测患者全血中环孢素A（Cs A）和他克莫司浓度的室内质控结果。方法 对四川省医学科学院·四川省人民医院药学部实验室2013年6月~2014年9月作Cs A和他克莫司血药浓度监测的随行质控结果进行评价与分析,建立常规中心线及控制限,绘制质控图。结果 Cs A和他克莫司低、中、高3个水平的常规中心线分别为69.19、159.41、388.11 ng/m L和5.21、9.20、19.34 ng/m L;Cs A的低、中、高浓度的日内和日间精密度的RSD分别为10.38%、8.61%、9.40%和16.10%、13.31%、12.64%,相对回收率分别为95.26%、110.65%、107.51%和104.80%、98.30%、98.18%;他克莫司的低、中、高浓度的日内和日间精密度的RSD分别为10.21%、8.69%、4.29%和19.93%、14.02%、13.96%,相对回收率分别为117.20%、107.55%、103.47%和112.20%、105.00%、104.00%,均符合《中国药典》2010年版的要求。运用Westgard多规则控制方法对质控结果进行分析检出Cs A失控2次;他克莫司失控7次。结论 EMIT测定Cs A和他克莫司血药浓度具有较好的精密度和稳定性,适于临床开展治疗药物监测,但应建立质控方法对质控结果进行评估,以保证实验室测定数据的准确性,为临床提供准确的监测结果。

Objective To evaluate and analyze the enzyme-multiplied immunoassay technique（EMIT） to monitor the patient whole blood Cyclosporine A（Cs A） and Tacrolimus concentrations of internal quality control results. Methods The quality control results, which were accompanied with blood concentration monitoring of Cs A and Tacrolimus in a laboratory from June 2013 to September 2014 were evaluated and analyzed, the conventional centerline and control limits were established, control chart was drawn. Results The low, medium and high levels of conventional centerline of Cs A and Tacrolimus were 69.19, 159.41, 388.11 ng/m L and 5.21, 9.20, 19.34 ng/m L respectively. Cs A low, medium and high concentrations of intra-day and inter-day precision（RSD） were 10.38%, 8.61%, 9.40% and 16.10%, 13.31%,12.64%; relative recoveries were 95.26%, 110.65%, 107.51% and 104.80%, 98.30%, 98.18%. Tacrolimus low, medium and high concentrations of intra-day and inter-day precision（RSD） were 10.21%, 8.69%, 4.29% and 19.93%, 14.02%,13.96%; relative recovery were 117.20%, 107.55%, 103.47% and 112.20%, 105.00%, 104.00%. They were all complied with the requirements of Chinese Pharmacopeia（2010 edition）. Westgard multi-rules control method had detected Tacrolimus with 7 times out of control and Cs A with 2 times out of control. Conclusion EMIT assay for Cs A and Tacrolimus blood concentration have good precision and stability, and are suitable for clinical therapeutic drug monitoring carrying out. But in order to ensure the laboratory measurement accuracy of the data and to provide accurate monitoring results for clinical use, it should establish quality control methods for quality control.