19S-IgM-TPPA试验诊断先天梅毒评价

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。

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

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.