他克莫司血药浓度的方法学评价

Method Evaluation on Plasma Concentration of Tacrolimus

评价德灵公司均相酶法他克莫司（Tacrolimus）试剂盒检测他克莫司血药浓度的可靠性。用本方法在日立7600分析仪上对其检测他克莫司血药浓度的精密度、线性、回收率、相关性等指标进行评价。本方法的评价表明,在他克莫司质控浓度为5.0ng/mL和15.0ng/mL时,批内变异系数分别为14.17%、10.66%,批间变异系数分别为12.56%、9.92%。平均回收率95.98%,在1.5~30ng/mL范围内,线性良好。与微粒子酶联免疫吸附法测定相关性良好（r=0.93）。结论：该方法操作简便、快速、准确,多通道检测,适用于临床上对肝肾移植患者他克莫司药物谷值浓度的监测。

To evaluate the reliability of Tacrolimus assay reagent from DADE BEHRING on the measurement of plasma concentration of tacrolimus,the precision,linearity,recovery rate and correlation of this method were evaluated on HITACHI 7600 analyzer.The results showed that the intra-assay CV of low and middle level of this assay were 14.17% and 10.66% respectively,and the inter-assay CV of low and middle level was 12.56% and 9.92% respectively when the plasma concentration control of tarcolimus were 5.0 ng/mL and 15.0 ng/mL.The average recovery rate of assay was 95.98%.The plasma concentration assay showed good linearity in the range of 1.5-30ng/mL.The correlation coefficient of this assay with MEIA was 0.93.The assay tested in this study is simple,quick,accurate and consequent suitable for monitoring of Tacrolimus concentration in kidney transplant patients.