全自动血凝分析仪性能验证方案  

Protocol for Evaluation of the Automated Coagulation Analyzer

作　　者：王威[1] 王刚[1] 

机构地区：[1]西安交通大学第一附属医院检验科,西安710061

出　　处：《现代检验医学杂志》2017年第5期157-160,共4页Journal of Modern Laboratory Medicine

摘　　要：设备在安装时及常规使用中需要通过性能验证来评估其性能指标,来判断设备是否符合相关检验所要求的规格。全自动血凝分析仪由于其检测项目的特殊性,必须建立和实施与之相匹配的性能验证方案。该文参照CLSI相关文件总结出可行的适用于全自动血凝分析仪的性能验证方案,并进行综述。When the device is installed, it needs to be verified by some special tests to evaluate its performance and to determine whether the device is in accordance with the requirements of the relevant inspection specifications. The projects of the automated coagulation analyzer are particularity different from other tests, especially the biochemistry tests. So the clinical laboratory should establish and implement the matching performance validation protocol. This article refers to the CLSI re lated documents to summarize a feasible and applicable evaluation protocol, helping for evaluating automated coagulation analyzer.

关 键 词：全自动血凝分析仪 性能验证 CLSI文件 

分 类 号：R446[医药卫生—诊断学]