雅培全自动生化分析仪检测系统性能验证  

Verification of performance of ARCHITCT automatic Biochemistry Analyzer

作　　者：王晓娜[1] 

机构地区：[1]辽宁省沈阳市妇婴医院,110011

出　　处：《检验医学与临床》2013年第A02期33-35,共3页Laboratory Medicine and Clinic

摘　　要：目的评价雅培cil6200全自动生化分析仪的分析性能。方法按照美国临床实验室标准化协会CLSI公布的文件标准（EP5-A2，EP9-A2，EP10-A2，EP6-A2），对雅培精密度、准确度、携带污染率、线性范围等4个性能进行验证。结果批内精密度、批间精密度、准确度偏倚均低于1／4Tea（CLIA’88），携带污染率小于0．5％，线性范围结果与厂商提供的性能指标相符。结论雅培生化分析仪在精密度、准确度、携带污染率、线形范围等4个方面性能验证合格。Objective To demonstrate the analytical performance of ARCHITCT Automatic Biochemistry Analyzer. Methods The precision,accuracy,carried contamination and linearity were validated according to Clinical and Laboratory Standards Institute（CLSI）documents（EP5-A2,EP9-A2,EP10 A2,EP6-A2）. Results The within and be tween-batch precisions and accuracy evaluation experiments were all less than 1/4 Tea（CLIA＇88）. The carried contamination percentage of each item was under 0.5%. The linearity was in line with manufacturer＇s standards. Conclusion The main performance of precision, accuracy,carried contamination and linearity of ARCHITCT Automatic Biochemistry Analyzer was eligible.

关 键 词：全自动生化分析仪 精密度 准确度 性能验证 

分 类 号：R446[医药卫生—诊断学]