2种生化检测系统测定ALT结果的比对及偏差评估

Comparative study and deviation evaluation the results of ALT detected by two biochemical detection systems

目的通过对2种生化检测系统进行方法学比对和偏差评估,探讨二者检测丙氨酸氨基转移酶(ALT)的结果是否具有可比性。方法按照NCCLS的EP9-A文件要求,以罗氏INTEGRA 400Plus检测系统为比较方法,奥林巴斯AU640检测系统为实验方法,用40份体检者新鲜血清分别在2套生化检测系统进行双份重复测定ALT,计算相关系数、直线回归方程及预期偏差,以CLIA'88规定的室间质量评价作为标准,判断在2种检测系统的检测结果临床可接受性。结果相关系数R=0.999>0.975,R2=0.999>0.95,检测相关性良好,不同医学决定水平的预期偏差在CLIA88允许误差的1/2之内。结论罗氏INTEGRA 400Plus与奥林巴斯AU640检测系统测定ALT结果具有可比性,可在任何一系统进行ALT的测定。

Objective To develop the contrast test and deviation evaluation to ALT results which detected by 2 biochemical detection systems,and explored the comparability of the 2 methods.Method According to EP9-A document of NCCLS,Roche INTEGRA 400 Plus detection system as control,OLIMPUS AU640 detection system was the empirical method,alanine aminotransferase（ALT） in 40 fresh sera were measured by the 2 methods,calculated the correlation coefficient,linear regression equation and expectant deviation,the results which detected by the 2 methods were evaluated according to CLIA＇88,judgment the clinical acceptability of the 2 methods.Results The correlation coefficient R1 was 0.9990.975,R2 was 0.9990.95,correlation was well,the expectant deviation in 1/2 of CLIA88 allowable error.Conclusions The ALT results detected by Roche INTEGRA 400 Plus and OLIMPUS AU640 had comparability,and it can be detected by the 2 detection systems.