19S-IgM-TPPA试验诊断先天梅毒评价

Evalution of Serum 19S-IgM Treponema Pallidum Particle Agglutination Assay in the Diagnosis of Early Congenital Syphilis

目的:评价血清19S-IgM-梅毒螺旋体明胶颗粒凝集试验(19S-IgM-TPPA)诊断早期先天梅毒的应用价值,以指导临床实践。方法:以2003年3月-2006年2月期间符合纳入标准的156例婴儿为研究对象,对他们进行血清19S-IgM-TPPA试验,并随访至明确诊断。以回顾诊断为标准。结果:156例婴儿中,141例婴儿完成随访,其中123例排除先天梅毒,18例婴儿被确诊为早期先天梅毒(有症状14例,无症状4例)。19S-IgM-TPPA试验阳性结果16例,假阳性2例,假阴性4例,敏感性77.78%(有症状78.57%,无症状75%),特异性98.37%,诊断指数176.15%;阳性预测值87.5%,阴性预测值96.8%,调整预测值无改变;阳性似然比47.83,阴性似然比0.226。结论:19S-IgM-TP-PA诊断先天梅毒敏感性较好,特异性很高,对有症状早期先天梅毒,在常规标准血清试验确定前即可证实感染的存在,用于先天梅毒的诊断是良好的预测工具,在已经有TPPA的实验室中,19S-IgM-TP-PA不失为一种诊断先天梅毒的可供选择的方法。

Objective ：To evaluate the clinical value of serum 19S-IgM treponema pallidum particle agglutination assay（19S-IgM-TPPA） in diagnosis of early congenital syphilis. Methods： 156 neonate or infant cases were consistent with the diagnosis criteria for the congenital syphilis tested by 19S-IgM-TPPA and followed up. According to follow-up results, the practical value of 19S-IgM- TPPA was evaluatal. Results： Among 156 cases, 141 were completed follow-up. 123 were excluded congenital syphilis and 18 cases were diagnosed as early congenital syphilis （14 symptomatic and 4 asymptomatic cases）. 19S-IgM-TPPA test were positive in 16 infants, 2 false-positive and 4 false negative. Sensitivity rate was 77.78% （ symptomatic 78.57%, asymptomatic 75% ）, specificity 98.37%, diagnostic index 176. 15%, respectively. Positive predictive value is 87.5%, negative predictive value is 96. 8%. Adjusted predictive values don＇t change. Positive likelihood ratio is 47.83, negative likelihood ratio is 0. 23. Conclusion： 19S-IgM-TPPA is a good tool to predict congenital syphilis and can be used to identify symptomatic treponema pallidum infectionin infants before classic serologic studies confirm the diagnosis of early congenital syphilis. 19S-IgM- TPPA can be a choice to be used in diagnosis of early congenital syphilis.