酶法测定肾移植患者血浆总霉酚酸的浓度

Determination the concentration of mycophenolic acid in renal transplantation recipients by enzymatic assay

目的通过测定次黄嘌呤单核苷酸脱氢酶Ⅱ(IMPDHⅡ)酶活性,建立一种简便、快速、准确且适用于多种常规生化仪检测的人血浆总霉酚酸(MPA)浓度的测定方法。方法采集分离70例肾移植患者术后稳态浓度的血浆样品,用总霉酚酸诊断试剂盒(TMPA),同时在分别产于美国、瑞士、日本的3台不同的生化仪上进行检测,并对结果进行统计分析。结果霉酚酸浓度在0.4～15.0μg.mL-1内,线性关系良好,最低检测限为0.3μg.mL-1。3台不同生化仪上测得的MPA浓度都在控制范围内,并且三者之间无显著差异(P<0.05)。以瑞士产生化仪检测结果(Y)对美国与日本产生化仪测定结果(X)作Passing-Bablock线性回归,相关系数r分别为0.9989和0.9982;并对其进行Bland-Alt-man一致性分析,3台仪器测得的MPA平均浓度偏差在±0.02μg.mL-1,三者一致性非常好。结论总霉酚酸诊断试剂盒操作简便、快速,准确,对测定仪器没有严格要求。

Objective To establish a simple,rapid and accurate method suitable for a variety of routine clinical chemical analyzer by monitoring IMPDHⅡ activity for quantification of mycophenolic acid in human plasma.Methods Samples from 70 renal transplantation recipients were collected.The concentration of MPA was evaluated by TMPA kit（Roche） on Architect C16000（Abbott）,Modular（Roche） and AU 2700（Olympus） analyzer.The obtained results were satistically analyzed.Results The calibration curve was linear among range of 0.4-15 μg·mL-1 and the limit detection was 0.3 μg·mL-1.All results were within quality control and no significant differences were observed by one-way ANOVA analysis.The Passing-Bablock regression showed very good agreement between Modular and Architect or AU 2700（γ=0.9989 or 0.9982,respectively）.No significant bias was found between three analyzers（Bland-Altman plot）,and median relative difference was ±0.02 μg·mL-1.Conclusion As a simple,rapid and accurate method,TMPA kit is universal for many clinical chemical analyzers.