干、湿生化分析仪部分测定值的比对分析和偏倚评估

Comparison analysis and bias evaluation on some determination results between wet type biochemistry and dry type biochemistry analyzers

目的根据美国临床实验室标准化委员会(NCCLS)EP9-A2文件,对日立7600-020湿化学分析系统(以下简称7600-020系统)和美国强生Vitros-950干化学分析系统(以下简称Vitros-950系统)进行方法学比对、相关性分析和预期偏倚评估,为向临床解答2种生化分析系统测定结果差异的可接受性提供实验依据。方法按照NCCLS EP9-A2文件的要求,以7600-020系统为比较方法,以Vitros-950系统为实验方法,对患者样本的尿素(Urea)、丙氨酸氨基转移酶(ALT)、肌酸激酶(CK)和血糖(Glu)4个较常用的项目进行方法学比对、相关性分析和预期偏倚评估,并判断偏倚是否可以接受。结果Urea、ALT、Glu和CK比对结果的相关系数(r)均高于EP9-A2文件规定的要求(r≥0.975),有较好的相关性;除Urea测定在医学决定水平2.5和6.4 mmol/L处偏倚不可接受外,其余项目的测定结果预期偏倚均未超出要求范围。结论在做好质控的基础上,7600-020系统和Vitros-950系统对ALT、Glu、CK和高浓度的Urea的检测能得到一致的结果,两者无明显差异。

Objective To evaluate the wet type analyzer（HITACHI 7600-020） and the dry type analyzer（Johnson Johnson Vitros-950） on their methodology,correlation and anticipated bias,according to the Document EP9-A2 of the National Committee for Clinical Laboratory Standards（NCCLS） and prove that the result deviation between the two systems can be accepted in clinic.Methods According to the NCCLS EP9-A2,HITACHI 7600-020（as the comparison method） and Johnson Johnson Vitros-950（as the laboratory method） were used respectively to determine urea,alanine aminotransferase（ALT）,creatine kinase（CK） and glucose（Glu） of the samples and evaluated the bias within methodological linear limitation.Results Among these testing results,the correlation of urea,ALT,CK and Glu was fine（r≥0.975）.Except that the bias of urea was unacceptable at medical decision level 2.5 and 6.4 mmol/L,the biases of other routine biochemical tests could be accepted between two analytical systems.Conclusions The ALT,Glu,CK and high level urea can be tested by the two biochemical and analytical systems.