罗氏cobas 8000全自动生化分析仪的性能验证  

Performance verification on ROCHE cobas 8000 automatic biochemical analyzer

作　　者：梅旭[1] 刘政[1] 邱广斌[1] 

机构地区：[1]中国人民解放军第二O二医院检验科,辽宁沈阳110812

出　　处：《国际检验医学杂志》2014年第16期2235-2236,共2页International Journal of Laboratory Medicine

摘　　要：目的：验证罗氏 cobas 8000全自动生化分析仪的分析性能。方法按照 NCCLS 推荐的 EP5-A2验证批内和批间精密度，按照 EP15-A2文件验证准确度，按照 NCCSL EP6-A 文件验证线性范围，按照 CLSI C28-A2文件验证参考区间。结果批内精密度在0．5％～2．3％，批间精密度在0．8％～3．11％，结果均小于1/4 Tea（CLIA′88）；各项目的检测结果与靶值均有较好的相关性（r2＞0．99）；各个检测项目的线性范围均符合试剂说明书给定的线性范围；引用的生物参考区间均符合本实验室服务的人群。结论罗氏 cobas 8000全自动生化分析仪的各项性能指标均符合质量要求，可用于临床常规生化检测工作。Objective To verify the analytical performance of the Roche cobas 8000 automatic biochemical analyzer.Methods The intra-batch and inter-batch precisions,accuracy,linearity and reference interval were validated according to the Clinical and La-boratory Standards Institute （CLSI）documents （EP5-A2,EP15-A2,EP6-A;C28-A2 ）.Results The intra-batch precision was 0.5%-2.3% and the inter-batch precision was 0.8%-3.11%,which were all less than 1/4 Tea（CLIA＇88）.The detection results of various items had better correlation with the target values（r2 ＆gt;0.99）;the linear range of various detected items were in line with the linear range provided by the specification;the quotative biological reference range conformed to the group of this laboratory services.Conclusion The various performance indexes of the Roche cobas 8000 automatic biochemical analyzer conform to the qual-ity requirements and this analyzer can be used in clinical biochemical detection work..

关 键 词：性能验证 精密度 准确度 线性范围 参考区间 

分 类 号：R446.1[医药卫生—诊断学]