γ-谷氨酰基转移酶参考方法的建立与性能评估

目的建立γ-谷氨酰基转移酶（GGT）参考方法,对其性能进行评价,为临床常规检测GGT提供可比性和溯源性。方法根据国际临床化学联合会（IFCC）颁布的GGT一级参考测量程序（37℃）要求,建立GGT一级参考方法（其中包括所需仪器、试剂、样本的准备与校准等实验条件的试验）,并对其进行精密度、准确性和最大线性范围检测。结果 GGT参考方法的精密度评价A、B 2个水平样本变异系数（CV）总均〈1%,符合精密度性能要求。有证参考物质（ERM-AD452/IFCC）均值为113.27 U/L,均值与靶值的偏倚为-0.64%,在允许范围内。GGT的最大线性范围为413.81 U/L,高于IFCC公布的GGT参考方法的最大线性范围（276.40 U/L）。结论 GGT参考方法已基本建立,精密度、准确度及线性范围等性能指标均符合方法要求,为我国参考实验室网络的建立提供了基础,临床应用将更加广泛。

Establishment and evaluation of the reference methods for gamma-glutamyltransferase

Objective To establish and evaluate the reference method of gamma-glutamyltransferase（GGT） and provide the comparability and traceability of determining GGT routinely in clinical laboratory.Methods The reference method for GGT including the preparation and calibration of instruments,reagents and samples was established according to the documents issued by International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）.The precision,accuracy and linear range of the method were detected.Results According to the accuracy of GGT reference method,A and B horizontal samples were evaluated [total coefficient of variation（CVt）1%].For the reference material（ERM-AD452/IFCC）,the average value was 113.27 U/L,and the bias between the average value and the target value was-0.64% within the allowance range.The upper limit of the linear range of GGT was 413.81 U/L,which was higher than the data published by IFCC（276.40 U/L）.Conclusions The reference method for GGT has been established basically.The analytic performance such as precision,accuracy and linear range conforms to the requirements.The reference method has been established,which can be used widely in clinical laboratory routinely and for research.