关键词: γ-谷氨酰氨基转移酶, 正确度验证, 溯源性

Abstract:

Objective Through the comparison of 40 serum samples,gamma-glutamyltransferase（GGT） trueness verification materials with reference method assignment are employed to trace the terminal results of clinical laboratories to the international system of units（SI） of enzymology,in order to realize GGT determination results' comparability in clinical laboratories. Methods Determination systems composed by reagents of different brands（DiaSys,DNTS,Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura） were employed to conduct parallel test for the 40 serum samples and the A and B samples of trueness verification plan GGT program of the National Center for Clinical Laboratories,with 2-time tests for each sample and 3 d continual test. Meanwhile,based on the results,the bias for GGT program's medical decision level of 8 kinds of reagents and Roche reagent was evaluated,and the mean values and assignment biases of A and B samples of trueness verification plan for the 9 brands' determination systems were calculated. Results For the determination system composed by 8 brands of reagents,the biases among Wako,Sekisui,KHB,Huachen,SIEMENS,Maccura and Roche were <5.0% at medical decision level,the bias of DNTS at medical decision level was about 7%,and the bias of DiaSys at medical decision level is above 14%. In the 9 brands of reagents,the bias of the determination system composed by DiaSys and DNTS was above the judgement standard 5.5%,while the maximum bias of the determination system composed by Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura was less than 4.8%. Conclusions The result consistency and trueness of the determination system composed by Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura meet judgement standard.

Key words: Gamma-glutamyltransferase, Trueness verification, Traceability