四种梅毒血清学试验方法的应用评价

<Abstract>The evaluation of the 4 differentserologicalassays in the application for the diagnosis of syphilis

目的：为筛选敏感、特异、快速的梅毒血清学试验方法，用四种市售梅毒血清学试验试剂盒对３２ 例梅毒感染者进行测定。 方法：所有受试者均空腹取静脉血２ ｍ ｌ，分离血清后－ ２０℃保存备用；选用南京军区军事医学研究所提供的ＲＰＲ试剂盒、英国ＯＭＥＧＡ 试剂公司生产的ＴＰＨＡ 试剂盒、日本富士しゼオ株式会社生产的ＴＰＰＡ试剂盒和加拿大Ｑｏｕｒｕｍ Ｄｉａｇｎｏｓｉｓ公司生产的ＴＰ抗体胶体金试纸条（ＴＰ纸条）对３２ 例受试者血清同时进行测定，操作步骤及结果判定均按试剂盒说明书进行。 结果：①敏感性：３２ 例梅毒感染者ＲＰＲ法阳性２９ 例，弱阳性３例；ＴＰＨＡ 法阳性３１ 例；ＴＰＰＡ 法阳性２９ 例；ＴＰ纸条法全部阳性。四种方法的敏感性分别为１００％ 、９６．９％ 、９０．６％ 和１００％ 。②特异性：１３ 例心磷脂抗体阳性而无梅毒感染者的血清，四种方法检出的阳性例数分别为３例、１例、０ 例和０例，特异性分别为９０．６％ 、９６．９％ 、１００％ 和１００％ 。③简便性：方法最为简便的是ＴＰ纸条，打开纸条直接插入血清中１５ ｍ ｉｎ 后即可观察结果；其他三种方法也较为简便，均可使用。④用时：ＲＰＲ、ＴＰ纸条均在１５ ｍ ｉｎ 内可判定结果，ＴＰＨ?

Abstract:Objectives:To select a sensitive,specific and rapid serodiagnosis assay for syphilis in vitro from 4 different m ethods:RPR,TPHA,TPPA and TP. Methods:Thirty-tw o sera from patients w ith syphilis w ere detected by the 4 m ethods sim ultaneously. RPR Kit w as provided by Nanjing Military Medical Research Institute.TPHA and TPPA Kits w ere produced by Om ega Inc,UK and Fujirebio Inc,Japan respectively.TPStripe Kit w as purchased from Qurum Diagnosis Inc,Canada.The procedures and reading for results w ere carried out according to the instruction ofthe kits. Results:By the above 4 m ethods,29, 31,29 and 32 positive sam ples w ere found orderly.The other 3 sam ples w ere w eak positive by RPR.3,1,0 and 0 sam ples w ere positive by the 4 assays in 13 sam ples w ith positive anti-cardiolipin antibodies from non-syphilis patients so the specifities w ere 90.6% ,96.9% ,100% and 100% respectively.The sensitivities of the 4 m ethods w ere 100.0% ,96.6% ,90.6% and 100.0% respectively.TPstripe w as the sim plestassay am ong the 4 assays and its results can be obtained w ithin 15 m inutes.The other three assays w ere also quite sim ple and available. Conclusions:RPR is a sim ple screening assay for serodiagnosis ofsyphilis and TPstripe is recom m anded as verification.