2台急诊生化分析仪部分检测项目的结果比对和偏倚评估

The result comparison and bias evaluation of part of the testing project between two emergency biochemical analyzer

目的通过对两台急诊生化仪部分检测项目的比对,探讨两种检测系统的结果是否具有可比性。方法依据美国临床实验室标准化委员会(NCCLS)的EP9-A2文件要求,以美国强生公司Vitros350生化仪作为参比系统,以贝克曼AU480生化仪作为试验系统,同时检测40例患者新鲜血清的总蛋白(TP)、清蛋白(Alb)、肌酐(Cr)、血糖(Glu),并计算相关系数(r)、决定系数(r2)和回归方程。并以美国临床实验室修正法规(CLIA'88)允许的总误差的1/2是否落在预期偏移的95%可信区间内来对临床可接受性进行分析。结果对比的所有项目在医学决定水平处的预期偏移均可被临床接受。结论两检测系统的结果具有可比性。

Objective To explore the comparability between the two emergency biochemical amilyzers by comparing a part of the inspection items of the two systems. Methods According to NCCLS EP9-2A document requirements, Vitros350 was used as the reference system,and the Backman AU480 was acted as the experimental system. Meanwhile, the TP, Alb,Cr and Glu of serum from 40 patients were tested. The correlation coefficient （r）, determination coefficient （r^2 ） and regression equation were calculated and the clinical acceptability was tested according to whether the half of the allowed total error of CLIA＇88 was in the 95 % credibil ity intervals of expected migration. Results The expected migrations of all items in the medical decision level could be accepted by clinical. Conclusion The results of the two systems are comparable.