干、湿化学两检测系统4种生化分析仪检测结果的可比性评价

Comparability analysis of four different biochemical analyzers about dry or wet chemical detection systems

目的通过对同一临床实验室两检测系统四种不同生化分析仪进行结果的检测,探讨不同生化分析仪之间检测结果是否具有可比性。方法按照美国临床实验室标准化委员会(NCCLS)的EP9-A2文件要求,以OLYMPUS AU 5431全自动生化分析仪为比较方法(X),以OLYMPUS AU 5421全自动生化仪和强生VITROS 5.1FS、VITROS 5600干化学分析仪为实验方法(Y)。每天选取8份浓度覆盖可分析测量范围的新鲜血清标本,分别于4台不同生化仪对肌酸激酶(CK)、尿素(UREA)进行检测,计算其相关系数及回归方程,以CLIA′88规定的室间质量评比允许误差范围的1/2为标准,在不同医学决定水平判断不同检测系统的偏差在临床是否具有可接受性。结果 3种试验方法CK、UREA的检测结果均r2>0.95,在不同医学决定水平上3种试验方法CK、UREA的检测结果的偏差均可接受。结论 3种试验方法所测结果具有可比性,能满足临床要求。

Objective To explore the comparability of the test results by the trial between four different biochemical analyzers about two detection systems in the same clinical laboratory.Methods According to the Document EP9-A2 of National Committee for Clinical Laboratory Standards（NCCLS）,ACA OLYMPUS AU 5431 was taken as comparison method（X） and ACA OLYMPUS AU 5421,Does chemistry analyzers of Johnson Johnson VITROS 5.1FS and VITROS 5600 as laboratory method（Y）.Eight fresh serum samples,creatine kinase（CK） and UREA levels of which covered measurement range,were tested everyday by the four different biochemical analyzers respectively to obtain the correlation coefficient and linear equation and the bias between different systems at different medical determinate levels was analyzed according to the half of CLIA＇88 standard.Results The correlation coefficients of CK and UREA all exceed 0.95.The system bias of CK and UREA could be accepted at different medical determinate levels.Conclusion The comparability of the three laboratory methods accorded to evaluation of clinical acceptability.