首页> 中文期刊> 《医学理论与实践》 >不同生化检测系统测定项目的可比性及临床可接受性研究

不同生化检测系统测定项目的可比性及临床可接受性研究

         

摘要

目的:通过对不同检测系统进行方法比对分析,探讨各系统之间检测丙氨酸氨基转移酶(ALT )、天冬氨酸氨基转移酶(AST)、总蛋白(TP)、白蛋白(ALB)和血糖(GLU)五个项目测定结果具可比性。方法:依据美国临床实验室与标准化委员会(NCCLS )的EP-A2有关文件,选择具有代表性的五个检测项目,首先研究各个系统的精密度,再通过系统间的比对进行准确度、相关性分析。以日立(Hitachi )7600-110全自动生化分析仪作目标检测系统1,日立7170作实验检测系统2,强生(Vitros-)350全自动干式生化分析仪作为比对仪实验检测系统3,每天选取2份新鲜混合血清,分别在三台仪器上测定该五个项目,共测20次取其均值并记录结果。结果:五个项目在三个检测系统的日内精密度均小于CLIA’88(美国临床实验室修正法规)允许总误差(TEa)的1/4,日间精密度小于CLIA’88 TEa的1/3;各个试验系统与目标系统比对的相关系数 r>0.975,P>0.5,系统误差(SE%)小于CLIA’88规定的Ea的1/2。结论:三个检测系统的检测项目结果准确可靠,相关性良好,临床可以接受。%Objective :To discuss the comparability of 5 tests (ALT ,AST ,TP ,ALB ,GLU ) results among different systems ,which are analyzed by the methods compared .Methods :According to EP9-A file of NCCLS ,5 representative i-tems (ALT ,AST ,TP ,ALB ,GLU)are explored their precision of various systems ,and are analyzed the relationship , such as the precision ,the accurate and the relation liner through the comparation with different systems .The auto-chemical analyzer of Hitachi 7600-110 is target system 1 ,Hitachi 7170 and Vitro 350 are detection systems 2 and detec-tion system 3 respectively .There are 2 fresh combination serums daily and selected to detect 5 items in 3 detection sys-tems ,and 20 results appeared to their averages and write down the values .Results :The precision of within a day 5 tests results in 3 detection systems are lower than that of the quarters of CLIA ’88 TEa ,and the results day and day are low-er than that of one-third of CLIA’88 TEa;the relation liners between target system and detection systems are higher 0.975 ,and the possibility are higher 0 .5 ,the system errors (SE% ) are lower then that of one-second of CLIA’88 TEa . Conclusion:The comparation results of 3 different systems are accurate and rely ,the relation liners are perfect accorded evolution of clinical acceptability .

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