ELISA检测肿瘤相关抗原CA19-9的方法学评价  

Methodological Evaluation of ELISA Assay for Tumor Related Antigen CA19-9

作　　者：董振南[1] 丁慧[1] 贾兴旺[1] 金剑 田亚平[1] 

机构地区：[1]解放军总医院生化科,北京100853 [2]瑞典康乃格诊断公司,北京100022

出　　处：《标记免疫分析与临床》2009年第5期294-295,共2页Labeled Immunoassays and Clinical Medicine

基　　金：国家科技部863计划项目(2006AA02090206)

摘　　要：对肿瘤相关抗原CA19-9酶联免疫法(ELISA法)进行方法学评价。选取各类标本204份,将本方法的灵敏度、特异性、阳性预测值、阴性预测值与电化学发光免疫分析(ECLIA)的进行比较并综合分析。本方法检测的灵敏度为52.5%,特异性为82.9%,阳性预测值为82.1%,阴性预测值为54.0%。以ECLIA为相对标准,相对灵敏度为100%,相对特异性为100%,相对符合率为100%,与ECLIA相关性显著,r2=0.9749。相关分析结果表明,ELISA与ECLIA相关性好。本方法试剂稳定,结果准确、可靠,有很高的特异性。To evaluate the methodology of ELISA assay for CA19-9,204 serum samples were selected into this study. The sensitivity, specificity, positive predictive value, negative predictive value of this method was evalua- ted with compared reagent. The sensitivity of this method was 52.5% ,specificity was 82.9% ,PPV was 82.1% and NPV was 54.0%. When ECLIA was set as relative standard, the relative sensitivity, specificity and consis- tency were 100% , 100% and 100% respectively. The correlation coefficient was good and the relativity had sta- tistic significant different. The results indicate that the reagent used in this study is stable, and the measurement result is correct and reliable with high specificity.

关 键 词：肿瘤相关抗原 CA19-9 酶联免疫法 电化学发光免疫法 消化道肿瘤 

分 类 号：R730.4[医药卫生—肿瘤]