微粒子酶联免疫吸附法测定西罗莫司血药浓度的方法学评价

Method evaluation on plasma concentration of Sirolimous by MEIA

目的：通过西罗莫司（Sirolimous）试剂盒的化学性能测定，评价微粒子酶联免疫吸附法测定的可靠性。方法：用本方法在雅培IMX分析仪上对西罗莫司血药浓度的精密度、回收率、线性、相关性等指标进行评价。结果：本方法的评价表明，批内变异系数分别为2．4％，6．5％，1．8％，批间变异系数分别为8％，10．33％，11．9％，在1．5—30ng/ml范围内，线性良好。与高效液相色谱法测定相关性良好（r=0．9361）。结论：该方法操作简便、快速、准确，适用于临床上对肾移植患者西罗莫司药谷浓度的监测。

Objective： For evaluating reliability of Sirolimous assay reagent, chemical characters were determined. Methods： The precision, linearity and recovery rate and correlation of this method were evaluated. Results：The within-run CV of low ,middle and high level were 2.4%, 6.5%, 1.8% respectively. The between-run CV of low, middle and high level were 8%, 10.33%, 11.9% respectively. In the range of 1.5-30 ng/ml, result had gc,ed linearity. The correlation coefficient of this method with HPLC was 0.9361. Conclusion ：The method is simple, quick, acetate and suitable for monitoring the Sirolimous concentration of renal transplant patients.