γ-谷氨酰氨基转移酶检测结果一致性及正确性分析  

Consistency and accuracy of gamma-glutamyltransferase determination results

作　　者：梅四清[1] 缪希莉[2] 

机构地区：[1]武汉大学人民医院检验科,湖北武汉430060 [2]华中科技大学同济医学院附属武汉普爱医院,湖北武汉430030

出　　处：《检验医学》2017年第11期1051-1054,共4页Laboratory Medicine

摘　　要：目的通过40例血清样品比对及参考方法赋值的γ-谷氨酰氨基转移酶(GGT)正确度验证物质将临床实验室的终端结果溯源到酶学的国际单位(SI),同时实现临床实验室的GGT结果可比性。方法将各品牌(德赛、德诺、罗氏、和光、积水、科华、华臣、西门子、迈克)试剂所组成的检测系统,对40例血清样品及2015年国家卫生计生委临床检验中心正确度验证计划GGT项目A、B 2样品进行平行检测,每例样品检测2次,连续检测3 d。根据检测结果统计8种试剂与罗氏试剂在GGT项目医学决定水平处的偏移,计算9种品牌检测系统检测正确度验证计划A、B 2样品均值与赋值的偏移。结果 8种品牌试剂所组成的检测系统中,和光、积水、科华、华臣、西门子、迈克试剂与罗氏试剂在医学决定水平处的各偏移均<5.0%;德诺试剂医学决定水平处的偏移在7%左右;德赛试剂医学决定水平处的偏移均超过14%。9种品牌试剂中,德赛与德诺2试剂所组成的检测系统正确度偏移均超过5.5%的判断标准,而罗氏、和光、积水、科华、华臣、西门子和迈克试剂所组成的检测系统最大正确度偏移均不超过4.8%。结论和光、积水、科华、华臣、西门子、迈克与罗氏所组成的各自检测系统检测结果一致性、正确性均符合判断标准。Objective Through the comparison of 40 serum samples,gamma-glutamyltransferase（GGT） trueness veri？cation 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 veri？cation 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 veri？cation 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.

关 键 词：γ-谷氨酰氨基转移酶 正确度验证 溯源性 

分 类 号：R446.1[医药卫生—诊断学]