摘要
目的：对两种生化仪器进行方法学比对和偏差评估，探讨二者检测无偿献血者ALT结果的可比性。方法依据NCCLS的EP9-A2文件，以奥林巴斯A U400为参比方法，迈瑞B S200为实验方法，用40份献血者新鲜血浆分别在两种生化仪进行A L T双份重复测定，确定数据的有效性，计算相关系数、直线回归方程及预期偏差，以CLIA '88规定的允许误差判断两种仪器检测ALT结果的临床可接受性。结果数据有效，无离群值出现；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CLIA '88允许误差的1/2内。结论，迈瑞BS200与奥林巴斯AU400检测系统测定ALT结果具有可比性，应急情况下，迈瑞BS200可替代奥林巴斯AU400测定ALT。
Abstract
0bjective, to study the contrast test and deviation evaluation about the voluntary blood donors' ALT detected by two automatic biochemical Analyzers and investigate <br> the comparability of two Analyzers.Method , Using OLIMPUS AU 400 automatic biochemical Analyzers as the reference method,MINADRAY BS200 as the testing method, according to the file of EP9-A2.Then, the ALT in 40 fresh sera from he voluntary blood donors were measured repeated by two Analyzers.After the valid data was checked , the correlation coefficient , linear regression equation and expectant deviation was obtained,the results of ALT which detected by two Analyzers were evaluated according to CLIA'88 and the clinical acceptability of the two Analyzers was judged by the deviation of medical decision level.Results ,no outliers , R= 0.999 > 0.975, R2 = 0.999>0.95, correlation was wel. The expectant deviation was in 1/2 of CLIA '88 alowable error.Conclusions, ALT detected by OLIMPUS AU 400 and MINADRAY BS200 had comparability,and MINADRAY BS200 could be the substitute for OLIMPUS AU 400 in detecting of ALT in emergency .
NETL
NSTL
万方数据