他克莫司药物浓度检测结果的多中心差异性研究

Multicenter study of methods and variations intacrolimus detection in China

目的综合分析多中心他克莫司血药浓度的检测数据差异,为改善检测方法和质控水平提供数据支持。方法本研究采用的低、中和高浓度他克莫司质控液产品在国际参考实验室的检测标准分别为(4.70±0.325)μg/L、(8.46±0.548)μg/L和(13.50±0.966)μg/L。将低、中、高浓度的他克莫司质控液样本通过冷链寄往全国34家器官移植中心,每次3个样本量,不同时间段重复完成2~3次寄送,共得到240个质控液样本的检测数据,对其进行统计学分析。结果本研究中,得到的低、中、高浓度组数据分别为(4.79±0.605)μg/L、(8.49±0.948)μg/L和(13.99±1.604)μg/L。相比之下,国外数据在低、中和高浓度3个水平的测试标准差和变异系数均较小。国际参考实验室对低、中、高3个浓度他克莫司质控液检测的标准差分别约为0.3、0.5和1.0,被本研究定义为"国际水准";而本次行业内调研数据的标准差分别约为0.5、1.0和1.5,暂被定义为"行业内水准"。结论建议拟定目前"行业内标准"即低、中和高浓度的他克莫司血药浓度检测误差允许范围分别为±0.5、±1.0和±1.5,要求每批次的检测样本中均应有1~2个"质控液",在使用新批次的"检测试剂"前必需用"标准液"重新定标,每个月均需用"标准液"重新定标并保持和临床医师的沟通。

Objective To improve the level of detection method and quality control at different transplant centers in China and comprehensively analyze the data of tacrolimus(Tac)detection in multiple transplant centers and provide data supports.Methods Low,medium and high concentration commercial quality control products in triplicate samples were delivered to 34 domestic organ transplantation centers and testing repeated for 2~3 times during different time periods.The detection results of 240 quality control samples were summarized.The methods,accuracy and stability of Tac detection results were analyzed.Results In international standard laboratories,mean±standard deviation(SD)of Tac detection results of low/medium/high concentration commercial quality control products was(4.70±0.325),(8.46±0.548)and(13.50±0.966)respectively.Here the results were(4.79±0.605),(8.49±0.948)and(13.99±1.604)respectively.In contrast,SD and degree of variation of international standard data were smaller,indicating that the accuracy and stability of international standard laboratories in detecting Tac were higher.SD of Tac concentrations detected by international standard laboratory for low/medium/high concentrations was approximately 0.3,0.5 and 1.0 respectively,i.e.International first-class level.Here SD was approximately 0.5,1.0 and 1.5 respectively,i.e.Chinese industry level.Conclusions The"Chinese industry level"is recommended.Before using a new batch of"testing reagents","standard control samples"must be employed for calibrating the calculated curve.The calculated curve should be re-calibrated at least once per month.And clinicians should be consulted frequently.