酶增强免疫分析法监测他克莫司血药浓度质控评估

摘要

Objective: To explore the measurement quality that the blood concentrationa of TacrolimU8 by enzyme-multiplied immunoassay technique(EMIT)and establish quality control rule of blood concenUations of Tacrolimus which suit for our laboratory.Methods: The stabilization and precision of the method were analysis used standard as a sample copy.We analyzed and evalutUed the quality controJ results of 2009 in our laboratory.Results: There were a significant dirfferencebetween the blood concentrations of tacrolimus at 21℃, 23℃, 24℃ and that at 22℃ (P＜0.05); the RSD of tacrolimus was from 3.4％ to 10.1％, the recovery was from 96.1％ to 105.4％, they all met the requirements of pharmacopoeia and we established the new quality control results.Conclusion: This method have a certain consistency and a high precision and can apply to the clinical treatment, but must established a reasonable quality control rule.%目的:探讨用酶增强免疫分析法监测他克莫司血药浓度的质量,确定适合于本实验室的他克莫司药物监测质控规则.方法:以标准质控为样本,分析用酶增强免疫法测定他克莫司血药浓度方法的稳定性和准确性,并对我院2009年的质控结果进行评价、分析,建立新的质控规则.结果:在本实验室条件下,他克莫司测定值为20℃、21℃、23℃、24℃时,与22℃时测定值比较,差异均有统计学意义(P＜0.05);他克莫司高中低三个浓度的RSD为3.4%～10.1%,回收率为96.1%～105.4%,均符合<中国药典>对生物样品检测规定;本实验室新的质控规则为12s/13s/22s/41s.结论:用酶增强免疫分析法检测他克莫司血药浓度的方法稳定性和准确性较好,可以在临床中推广应用,但合理质控规则的建立是此方法实施的保障.