不同生化检测系统间血肌酐、血糖检测结果的可比性研究

Comparability of the Results Between the Different Automated Chemistry Analyzers

目的通过对同一实验室不同生化检测系统进行方法比对和偏倚评估,探讨不同生化检测系统间血肌酐(Cr)、血糖(Glu)测定结果是否具有可比性,为实验室认可提供可靠的实验数据。方法按照CLSI的EP9-A2文件要求,以Vitros950全自动干式化学分析法为参比方法(X),以Olympus AU640,2台DimensionXpand-HM生化分析仪分析为待比方法(Y),用不同浓度水平的患者新鲜血清对Cr、Glu分别进行检测,计算相关系数及直线回归方程,以CLIA’88规定的室间质量评价允许误差范围的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临床是否可以接受性。结果在不同医学决定水平上,三种待比方法Cr、Glu测定结果的偏差均可接受。结论当使用两个以上的检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。

Objective To investigate the comparability of the results of Cr and Glu on different automated chemistry analyzers through bias estimation and method comparison. Methods Following CLSI document EP9 - A2, different biochemical detecting system, detecting system Y1 -3（laboratory method） and detecting system X（ comparison method）, were used respectively the different concentration fresh serum of Cr and Glu to obtain the correlation coefficient and linear equation. Then the coefficient and the equation were used to evaluate the system bias between laboratory method and comparison method, we judge the comparability of different investigate systems according to the half of CLIA＇ 88 standard. Results The system bias of Cr and Glu could be accepted at different medical determinate level. Conclusion If the same test are determined by more than two systems, it is necessary to do method comparison and bias estimation for judge clinical acceptability in order to insure the comparability.