摘要
目的回顾分析酶联免疫吸附法(ELISA)测定他克莫司(FK506)血药浓度中随行质控结果数据,确定该实验室条件下FK506血药浓度监测结果的准确性。方法用ELISA法测定FK506血药浓度监测中随行质控的精密度和准确性,并绘制Levey-Jennings质控图,对该实验室质控结果进行统计学分析。结果方法学评价表明在他克莫司质控浓度为2.0μg.L-1和15.0μg.L-1时,批内变异系数分别为7.64%、3.85%,批间变异系数分别为8.47%、3.94%;回收率在99.7%～106.8%。他克莫司血药浓度监测过程中随行质控样品测定结果均"在控",RSD为5.84%、10.15%。结论 ELISA法监测FK506药物浓度具有良好的精密度和准确性,表明该实验室在长期的治疗药物监测中稳定性好,具有较好的临床指导意义。
Objective To determine FK506 accuracy of therapeutic drug concentration monitoring results in our laboratory conditions by analyzing the measured data of accompanying quality control in the process of monitoring the FK506’s blood concentration with the enzyme-linked immunosorbent assay（ELISA）.Methods ELISA method for determining the precision and accuracy of the drug concentrations treated with FK506 was analyzed by using accompanying quality control as samples.What’s more,the result of laboratory quality control in 2011 was evaluated.Results The evaluation of the methodology showed that when the tacrolimus level of QC was 2.0 μg.L-1,15.0μg.L-1,the coefficient of variation was 7.64%,3.85% respectively,inter-assay coefficient of variation was 8.47%,3.94% respectively and the recovery rate was between 99.7% ～ 106.8%.The measured results of quality control sample accompanied with Tacrolimus’blood concentration monitoring process were＂under control＂,RSD 5.84% and 10.15% in 2011.Conclusion ELISA method for monitoring the FK506’s drug concentration has good accuracy and precision,which means our laboratory has good stability and better clinical significance in the long-term therapeutic drug monitoring.
出处
《安徽医药》
CAS
2013年第7期1114-1116,共3页
Anhui Medical and Pharmaceutical Journal
基金
国家自然科学基金(No N081101313)
安徽省2012年度重点科研项目(No 12070403072)
