Roche Cobas e411检测心肌损伤标志物和降钙素原性能验证  

Performance verification of Roche Cobas e411 ECLIA analyzer in detecting biomarkers of myocardial injury and PCT

作　　者：王丽萍[1] 刘玲玲[1] 褚福禄[1] 张炳昌[1] 

机构地区：[1]山东大学附属省立医院检验科,济南250021

出　　处：《检验医学与临床》2015年第21期3147-3149,共3页Laboratory Medicine and Clinic

基　　金：山东省临床重点专科建设项目经费资助项目(鲁卫医字[2013]26号)

摘　　要：目的验证Roche Cobas e411电化学发光免疫分析法(ECLIA)检测心肌损伤标志物超敏肌钙蛋白T(hs-cTnT)、肌酸激酶同工酶质量(CK-MB mass)、肌红蛋白(MYO)、脑利钠肽前体氨基末端(NT-proBNP)和降钙素原(PCT)的分析性能。方法参照美国临床和实验室标准化委员会(NCCLS)相关文件,对Cobas e411检测hscTnT、CK-MB mass、MYO、NT-proBNP和PCT的准确度、精密度、携带污染率、线性范围进行验证。结果按照EP9-A2、EP5-A2、EP7-A2、EP6-A2文件要求验证得到各检测项目精密度的变异系数(CV)均小于3%,携带污染率小于0.1%;所验证项目的相关系数(r)>0.99;验证hs-cTnT的功能灵敏度为3pg/mL;与厂家声明一致。结论 Roche Cobas e411全自动电化学发光分析仪检测心肌损伤标志物和PCT的主要分析性能与厂家声明一致,适用于临床医学实验室用于这些项目的检测。Objective To verify the analytical performance of the electrochemiluminescence immunoassay（ECLIA）system in the Roche Cobas e411 analyzer for detecting hs-cTnT,CK-MB mass,MYO,NT-proBNP and PCT.Methods The accuracy,precision,contamination carryover rate and linear range of ECLIA system in the detection of hs-cTnT,CK-MB mass,MYO,NT-proBNP and PCT were analyzed according to the NCCLS evaluation protocols related guidelines.Results CV of precision of each item was all less than 3% according to the requirements of EP9-A2,EP5-A2,EP7-A2 and EP6-A2 documents.The contamination carryover rate of each item was less than 0.1%.r of each item was more than 0.99.The functional sensitivity of hs-cTnT was 3pg/mL,which was consistent with manufacturer′s claim.Conclusion The main analytical performance of the Roche Cobas e411 analyzer in the detection of hs-cTnT,CK-MB mass,MYO,NT-proBNP and PCT is consistent with manufacturer′s claim,applicable to clinical laboratory routine testing.

关 键 词：降钙素原 超敏肌钙蛋白T 肌酸激酶同工酶质量 肌红蛋白 脑利钠肽前体氨基末端 

分 类 号：R542.22[医药卫生—心血管疾病]