CAJ | 학술논문

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hs‐cTnT、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3 pg／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。
목적：험증Roche Cobas e411전화학발광면역분석법（ECLIA ）검측심기손상표지물초민기개단백T （hs‐cTnT）、기산격매동공매질량（CK‐MB mass）、기홍단백（MYO）、뇌리납태전체안기말단（NT‐proBNP）화강개소원（PCT）적분석성능。방법삼조미국림상화실험실표준화위원회（NCCLS）상관문건，대Cobas e411검측hs‐cTnT、CK‐MB mass、MYO、NT‐proBNP화PCT적준학도、정밀도、휴대오염솔、선성범위진행험증。결과안조EP9‐A2、EP5‐A2、EP7‐A2、EP6‐A2문건요구험증득도각검측항목정밀도적변이계수（CV ）균소우3％，휴대오염솔소우0．1％；소험증항목적상관계수（r）＞0．99；험증hs‐cTnT적공능령민도위3 pg／mL ；여엄가성명일치。결론Roche Cobas e411전자동전화학발광분석의검측심기손상표지물화PCT적주요분석성능여엄가성명일치，괄용우림상의학실험실용우저사항목적검측。
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 detec‐tion of hs‐cTnT ,CK‐MB mass ,MYO ,NT‐proBNP and PCT were analyzed according to the NCCLS evaluation proto‐cols 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 3 pg/mL ,which was consistent with manufacturer′s claim .Conclusion The main analytical performance of the Roche Cobas e411 analyzer in the de‐tection of hs‐cTnT ,CK‐MB mass ,MYO ,NT‐proBNP and PCT is consistent with manufacturer′s claim ,applicable to clinical laboratory routine testing .