血站实验室梅毒抗体酶联免疫吸附测定检测试剂的评价及应用

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17963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17963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.