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.