TEG~5000型血栓弹力图仪性能验证  

Performance verification of TEG~ 5000 thrombelastograph hemostasis analyzer

作　　者：赵磊[1] 徐双[1] 贾玫[1] 刘忱[1] 徐秦竹 

机构地区：[1]北京大学人民医院检验科,北京100044

出　　处：《医疗卫生装备》2015年第12期94-96,共3页Chinese Medical Equipment Journal

基　　金："首都临床特色应用研究"检验医学专项(Z121107005112011)

摘　　要：目的:对TEG~5000型血栓弹力图仪进行性能验证。方法:选取健康志愿者20例,男女各半,采血抗凝并充分混匀,立即送检,在2 h内检测。参照美国临床和实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)的EP15-A2、CLSI C28-A2、CLSI EP9-A2文件对TEG~5000型血栓弹力图仪的精密度、正确度、生物参考区间、通道间比对进行实验验证。结果:各项目批内精密度在0~4.8%之间,室内精密度在0~4.4%之间,结果均符合说明书给定范围;参考物质靶值均在验证区间内;引用的生物参考区间符合实验室服务的人群;两通道比对,各项目r^2均大于0.95。结论:TEG~5000型血栓弹力图仪的主要性能指标符合质量要求,可用于常规检测工作。Objective To verify the analytical performance of TEG 5000 thrombelastograph hemostasis analyzer. Methods Totally 20 healthy volunteers, 10 males and 10 females, had the blood collected, antieoagulated, blended and submitted in 2 h. The precision, accurateness, biological reference range and etc of the analyzer were validated with references to EP15-A2, CLSI C28-A2 and CLSI EP9-A2 from Clinical and Laboratory Standards Institute （CLSI）. Results All testing items had the within-run precision between 0 and 4.8% and the within-laboratory precision between 0 and 4.4%, which were complied with the specification of the analyzer. The assigned values of all testing items were included in the verification intervals. The quotative biological reference range conformed to group of this laboratory services. Comparison of the two channels proved r2 values of all testing items were greater than 0.95. Conchuslon The main performance indexes of TEG 5000 thrombelastograph hemostasis analyzer meet the standards of the quality requirements, which can be used in routine tests. [Ghinese Medical Equipment ,Journal, 2015,36（ 12 ）：94-96]

关 键 词：血栓弹力图仪 性能验证 精密度 正确度 结果比对 

分 类 号：R446.1[医药卫生—诊断学]