均相酶免疫分析法测定霉酚酸血药浓度的方法学评价

Measurement of mycophenolic acid level in blood by homogeneous phase enzyme immunoassay

  • 摘要: 目的 建立霉酚酸(MPA)血药浓度方法学平台并评价试剂盒的稳定性。方法 评价霉酚酸血药浓度的精密度、回收率、线性等相关指标,并分析经霉酚酸和他克莫斯(FK506)联合用药患者血标本中两种药物血药浓度的相关性。结果 高、中、低浓度批内变异系数分别为7.08%,1.49%,2.16%,批间变异系数分别为8.51%,5.93%,3.12%,在0.1-15μg/ml范围内,线性良好。与FK506的联合用药检测中未发现相关性。结论 该方法操作简便、快速、准确、稳定,可用于临床病人霉酚酸血药浓度监测。

     

    Abstract: Objective To establish the platform of homogeneous phase enzyme immunoassay for measuring mycophenolic acid(MPA) level in blood and evaluate its stability. Methods Precision and linearity of homogeneous phase enzyme immunoassay and recovery rate of MPA were evaluated,and correlation between MPA and tacrolimus(FK506) levels in blood of patients were analyzed. Results The within-run and between-run coefficient of variation(CV) of MPA were 7.08%,1.49%,2.16% and 8.51%,5.93%,3.12%,respectively,in blood of patients,with a good linearity when MPA was used at the concentration of 0.1-15μg/ml.However,no correlation was found between FK506 and MPA levels in blood when they were used in combination. Conclusion Homogeneous phase enzyme immunoassay is a simple,accurate and stable method for monitoring the MPA level in blood of patients in clinical practice.

     

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