运用CLSIEP方案对SysmexCA系列全自动血凝仪进行性能验证  

Verification of Performance of Sysmex CA-7000 & CA-1500 Automatic Coagulation Analyzer by CLSI EP Method

作　　者：王一杉[1] 崔薇薇[1] 梅燕萍[1] 

机构地区：[1]南京医科大学附属南京医院医学检验科,南京210006

出　　处：《医疗卫生装备》2014年第2期91-93,153,共4页Chinese Medical Equipment Journal

摘　　要：目的:对希森美康公司CA-7000、CA-1500型全自动血凝仪检测系统主要分析性能进行验证。方法:参照美国临床和实验室标准化协会(CLSI)的EP文件及相关文献有关检测系统性能验证文件EP15-A、EP6-A、EP-9A2、EP6-A、EP10-A的方法对选定检测项目的精密度、准确度、检测系统的比对、可报告范围、携带污染率进行评价。结果:希森美康CA-7000、CA-1500检测PT、APTT、Fbg的批内精密度、批间精密度、准确度、可报告范围、携带污染率均在允许范围内,CA-7000与CA-1500测定结果相关性良好。结论:该系列血凝仪的性能基本符合临床实验诊断学实验的要求,Fbg的可报告范围在找到合适样本的情况下要重新进行测定。Objective To evaluate the performance of Sysmex CA-7000＆CA-1500 Automatic Coagulation Analyzer. Methods The test repeatability, accuracy, analytical measurement range （AMR）, carry-over rate and the results of comparability among different test systems were evaluated according to CLSI EP15-A, EP6-A, EP-9A2, EP6-A and EP10-A methods. Results The two detection systems showed precision, AMR and carry-over rate within the allowed range and had a good correlation. Conclusion The performance of these two coagulation analyzers meets the requirement of clinical trials diagnosis. AMR of FBG has to be reexamined if the suitable sample can be found. [Chinese Medical Equipment Journal, 2014,35 （2） ： 91-93,153]

关 键 词：CLSI方案 全自动血凝仪 性能验证 

分 类 号：R446.1[医药卫生—诊断学]