CA-7000全自动血凝仪性能评价的探讨  

Performance evaluation of CA-7000 automatic coagulation analyzer

作　　者：简正伟[1] 胡意[1] 张世锟[1] 郭萍[1] 朱清[1] 石淙[1] 万腊根[1] 

机构地区：[1]南昌大学第一附属医院检验科,江西南昌330006

出　　处：《实验与检验医学》2012年第6期548-551,554,共5页Experimental and Laboratory Medicine

基　　金：江西省科技支撑计划项目(编号:20121BBG70049)

摘　　要：目的对SYSMEX公司生产的CA-7000全自动血凝仪进行性能评价。方法用level I和levelⅡ2个浓度值的质控品对其检测凝血酶原时间（PT）、活化部分凝血酶原时间（APTT）、纤维蛋白原（Fg）进行批内、批间不精密度;用卫生部室间质评物来检测PT、APTT、Fg正确度;取20个健康人群来检测PT、APTT、Fg进行生物参考区间转移的验证;检测高值和低值标本PT、APTT和Fg并进行携带污染率评价;参考CLSI的H21-A4文件确定其检测PT的正常值;用高低值标本来检测Fg的检测限、线性范围和可报告范围的评价。结果CA-7000检测PT、APTT批内CV%〈3.75%,Fg批内CV%〈5.0%;PT、APTT批间CV%〈5.0%,Fg批间CV%〈6.67%;检测PT、APTT、Fg的偏倚分别小于5.0%、5.0%、6.67%;检测PT、APTT、Fg的携带污染率符合要求;检测PT的正常值为10.99S;检测Fg的检测限为0.48g/L、线性范围为1.059~6.34g/L、可报告范围为56g/L。结论CA-7000全自动血凝仪各项性能指标符合要求,可用于临床检测。Objective To evaluate the performance of SYSMEX CA-7000 automatic coagulation analyzer.Methods The in-run and between-run imprecision of prothrombin time（PT）,activated partial thromboplastin time（APTT） and fibrinogen（Fg） detection were evaluated by using quality control samples of level I and level Ⅱ concentration.The trueness of PT,APTT and Fg detection were evaluated by using external quality assessment samples of National Center for Clinical Laboratories.Twenty samples from healthy persons were used to validate the biology reference interval.The carry over rate was evaluated by detecting high-level concentration and low-level concentration samples.H21-A4 of CLSI was deployed to determine the normal value of PT detection.High-level concentration and low-level concentration samples were used to determine the detect limit,linear range and reportable range of Fg detection.Results The in-run imprecision of PT,APTT and Fg detection were less than 3.75%,3.75%,and 5.0% respectively.The between-run imprecision of PT,APTT and Fg detection were less than5.0%,5.0% and 6.67% respectively.The bias of PT,APTT and Fg detection were less than 5.0%,5.0% and 6.67% respectively.The carry over rate of PT,APTT and Fg detection fits corresponding standard.The normal value of PT was 10.99 s.The detection limit,linear range and reportable range of Fg detection were 0.48g/L,（1.059~6.34） g/L and 56g/L respectively.Conclusions The performance of SYSMEX CA7000 automatic coagulation analyzer fits corresponding standard.SYSMEX CA-7000 automatic coagulation analyzer could provide reliable test results for clinic.

关 键 词：血凝仪 性能评价 PT APTT FG 

分 类 号：R446.111[医药卫生—诊断学]