目的：分析日本Olympus AU5400型全自动生化分析仪（简称AU5400）与美国Beckman Coulter AU5800型全自动生化分析仪（简称AU5800）、美国强生Vitros FS 5，1全自动干生化分析仪（简称FS 5,1）的葡萄糖(Glu)、钾(K+)、钙(Ca)、肌酐(Cr)四个项目检测结果的可比性。方法按美国国家临床实验室标准化委员会(NCCLS) EP9-A2文件，以AU5400为参考系统，AU5800和FS 5，1为试验系统，同时检测新鲜血清标本的Glu、K+、Ca、Cr，计算相关系数(r)和回归方程，并以1/2 CLIA'88允许偏差范围为标准，对临床可接受性进行分析。结果所有检测项目在试验系统与参考系统间的检测结果的相关系数均大于0.975；除Cr外，其他三项在医学决定水平处的预期偏倚都在临床可接受范围内。结论三套分析系统具有良好的相关性，Glu、K+、Ca三个项目的检测结果具有可比性，可相互认可并被临床所接受；Cr则对其在系统间的不可比性进行原因分析，并在校正后重新分析偏移评估和相关性，也在临床可接受范围内。%Objective To investigate the comparability of Glu, K+, Ca and Cr measurement between Olympus AU5400 analyzer, Beckman Coulter AU5800 and Vitros FS 5,1 analyzer. Methods According to the Ep9-A2 docu-ment of the Clinical and Laboratory Standards Institute, AU5400 analyzer was used as the reference system, and AU5800 and FS 5,1 analyzer were selected as the experimental system. Meanwhile, the levels of Glu, K+, Ca and Cr of serum were tested. The correlation coefficient and regression equation were calculated and the clinical acceptability was calculated according to the range of the half of the allowed total error of CLIA'88. Results There were significant cor-relation between the reference system and the experimental system in all the tested projects (r>0.975);the expected bias of the other three could be accepted in clinical acceptable range except Cr. Conclusion Three sets of analysis system has good correlation, and the examination of level Glu, K+and Ca have the commensurability, which can be mutually rec-ognized and accepted by clinical application. After analyzing the non-comparability of Cr between the three systems and re-evaluating the bias assessment and correlation, the result also can be accepted by clinical application.
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