不同检测系统间误差的分析评价

Comparison of different immunochemistry system based on National Committee for Clinical Laboratory Standards EP9-A2 document

目的评价我室2台IMMAGE全自动免疫分析仪之间的差异,确保使用2台仪器进行特种蛋白测定时结果解释的一致性。方法参照美国临床实验室标准化委员会(NCCLS)文件EP9-A2进行整个比对过程,比对项目为我室常规开展的9种特种蛋白。结果2台仪器9个项目的测定结果相关系数(r)均>0.975,在医学决定水平处(XC)的真实偏差即系统误差(Bc)均<允许误差(Ea)。结论2台仪器间差异在临床可接受范围内,可向临床提供准确一致的报告。

Objective To evaluate the difference between two IMMAGE immunochemistry systems in our laboratory and ensure the concordance of results in two IMMAGE. Methods We did this comparison in accordance to National Committee for Clinical Laboratory Standards （NCCLS） EP9-A2 （ method comparison bias estimation using patient sample） and the comparison contains 9 test items developed routinely in our laboratory. Results The correlation coefficient of 9 test items between two IMMAGE was higher than 0. 975 and true bias at concentration Xc （Bc） was smaller than acceptable error（Ea）. Conclusions The difference between two IMMAGE is in the clinical allowable range, our laboratory can provide the acute report for clinic.