摘要
目的对本血站实验室两种梅毒抗体筛查酶联免疫吸附测定(ELISA)试剂进行比较和评价。方法选择2013年12月至2014年3月北京市符合《献血者健康检查要求》(GB18467-2001)的无偿献血者血液标本17 963例,进行梅毒抗体的ELISA筛查和梅毒螺旋体明胶颗粒凝集试验(TPPA)确证。结果 17 963例无偿献血者标本中,107例血样呈ELISA法梅毒抗体反应性,反应性率为0.6%,TPPA确认反应性为83例,反应性率为0.5%,在本血站检验判断规则下,梅毒抗体ELISA检测灵敏度为100.0%,特异度为99.9%;其中两种ELISA试剂均呈反应性的为88例,灵敏度为98.8%,特异度为100.0%。103例金豪ELISA试剂检测反应性的标本中TPPA确认反应性数为82份,灵敏度为98.8%,特异度为100.0%,漏诊率为1.2%;92例万泰试剂检测反应性的标本,确认反应性为83份,灵敏度为100.0%,特异度为99.9%,漏诊率为0.0%。结论 ELISA方法单一种试剂梅毒抗体反应性假阳性率高,建议相应血液报废,献血者进行归队允许再次献血。
Objective To compare and evaluate two syphilis antibody screening enzyme-linked immu-nosorbent assay （ ELISA） kits used in the blood station laboratory. Methods Total of 17 963 cases blood donors′samples with the＂;donor health inspection requirements＂; （GB18467-2001） from Dec. 2013 to Mar. 2014 in Beijing were included,the syphilis antibody ELISA screening and Treponema pallidum particle ag-glutination（ TPPA） test were done. Results Among the 17 963 samples,107 blood samples showed ELISA syphilis antibody reaction,the reactive rate was 0. 6%,TPPA confirmed 83 samples were reactive,the reac-tive rate was 0. 5%,according to the rules of blood station laboratory,sensitivity of syphilis antibody ELISA was 100. 0%,specificity was 99. 9%. TPPA confirmed reaction number of 103 patients with Jinhao ELISA kit was 82,the sensitivity was 98. 8%,the specificity was 100. 0%,misdiagnosis rate was 1. 2%;confirmed reaction number of 92 Wantai reagent tested sampleswas 83 cases, the sensitivity was 100%, specificity of 99. 9%,misdiagnosis rate was 0. 0%. Conclusion It can be seen from the results of ELISA method of sin-gle reagent for syphilis antibody reactivity has high false positive rate,it′s suggested that the corresponding blood being scrapped,and the blood donors should be allowed to donate blood again.
出处
《医学综述》
2015年第19期3621-3622,共2页
Medical Recapitulate
基金
北京市科技工作基础专项(2013004)
关键词
献血者
梅毒抗体
真阳性率
Blood donors
Syphilis antibody
True positive rate
