运用EP15-A2对不同生化检测系统进行结果比对  

To Study the Results Comparability of Different Biochemical Detecting Systems According to EP15-A2

作　　者：冯磊[1] 年士艳[1] 徐文波[1] 张大莲[1] 张兴锋[1] 毛星星[1] 罗曼玲[1] 

机构地区：[1]玉溪市人民医院检验科,云南玉溪653100

出　　处：《医疗装备》2012年第4期16-19,共4页Medical Equipment

摘　　要：目的:对本实验室两套全自动生化分析系统罗氏ModularDPP模块与罗氏cobas c311进行结果比对。方法:以罗氏Modular DPP模块为比较系统,罗氏cobas c311为实验系统,依照EP15-A2文件中使用患者样本的真实度评价方案,对两套检测系统7项检测结果进行比对,绘制差值散点图,通过Excel对数据进行统计分析,以相对偏倚小于等于实验室质量要求(CLIA 88规定的1/2允许总误差)或小于等于偏倚验证值为判定标准。结果:两套检测系统上7个被评价项目经比对方案比对,结果均满足质量目标要求。结论:与EP9-A2方案相比,EP15-A2文件中使用患者样本的真实度评价方案,可达到同样的比对效果,但可操作性更强,更易于推广。Objective To compare the results between Roche Modular DPP and Roche cobas c311.Method According to National Committee for Clinical laboratory Standards（NCCLS） document EP15-A2,7 items of Roche Modular cobas c311 as the test system were compared with comparison system-Roche Modular DPP.According to clinical laboratory correcting code（CLIA′88）,the comparability of different detecting systems were analyzed according to the standard of half of the range of error allowed of quality evaluating within different Labs.Results Through the comparison,there was comparability between two systems,the result can meet with the qualitative demand.Conclusion Comparison with EP9-A2,EP15-A2 can get the same result,but has more practicability and maneuverability.

关 键 词：全自动生化分析仪 比对 NCCLSEP15-A2文件 

分 类 号：TH776[机械工程—仪器科学与技术]