生化分析仪模块间结果比对及偏差评估原因分析

Comparation and deviant assessement between the two modules of biochemical analyzer

目的对HITACHI7600-020生化分析仪的两个模块(P1和P2)的结果进行比对。方法以P1模块为对比方法,P2模块为试验方法,按照EP9-A2流程要求对葡萄糖、谷丙转氨酶、尿素氮、总蛋白进行检测。结果直线回归计算4个项目的相关系数r、r2、标准误Sy.X、斜率b、截距a和直线回归方程Y=bX+a。结果表明4个项目的相关系数r>0.975,偏差较小,无离群点,说明X的分布范围合适,可以回归分析两个模块间的系统误差。结论 4个项目的系统误差均可接受。

Objective To compare the results obtained from the two modules（P1 and P2） of HITACHI 7600-020 biochemical analyzer. Methods P1 module was regarded as the contrast method,and P2 module was the test method. In accordance with the EP9-A2,items including GLU、ALT、BUN and TP were analysed by the two modules. Results The correlation coefficient r、r 2 ,error Sy.X,slope b,and linear regression equation Y=bX ＋a of the four items were calculated by statistical method.The results showed that the correlation coefficient of the four items were all above 0.975（r 0.975）,there was small deviation and no outliers,X was properly scattered,and the systematic errors between the two modules can be analysed by appropriate regression. Conclusion Systematic errors of the four items are all acceptable.