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

摘要: 目的: 通过西罗莫司(S irolimous)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1.5～30 ng/m l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。

Abstract: 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 good linearity.The correlation coefficient of this method with HPLC was 0.9361.Conclusion: The method is simple,quick,accurate and suitable for monitoring the Sirolimous concentration of renal transplant patients.