Abstract：
OBJECTIVE: To evaluate the serological diagnosis value of recombinant protein antigen Tp0608 for syphilis.
METHODS: 406 patients with various stages of syphilis were enrolled. A recombinant protein antigen Tp0608 was established and ELISA was used to detect patients with various stages of syphilis. The results were compared with the conventional rapid plasma reagin test (RPR) and Treponema pallidum particle agglutination test (TPPA). The sensitivity of Tp0608 recombinant protein and RPR+TPPA screening was 96.6 % and 93.1 % respectively for patients with various stages of syphilis. For patients who may have cross reactivity, the specificity of Tp0608 recombinant protein screening is 98.9 %, and the AUC of the ROC curve is 0.99; The specificity of RPR+TPPA screening was 97.3 %, and the AUC of the ROC curve was 0.96. The sensitivity and specificity of Tp0608 recombinant protein in syphilis screening are higher than conventional RPR+TPPA methods, especially in congenital syphilis and primary syphilis.
CONCLUSIONS: The Tp0608 recombinant protein is a promising diagnostic antigen for syphilis screening, but its intracellular location and protective response have not been determined, and further verification is needed.
METHODS: 406 patients with various stages of syphilis were enrolled. A recombinant protein antigen Tp0608 was established and ELISA was used to detect patients with various stages of syphilis. The results were compared with the conventional rapid plasma reagin test (RPR) and Treponema pallidum particle agglutination test (TPPA). The sensitivity of Tp0608 recombinant protein and RPR+TPPA screening was 96.6 % and 93.1 % respectively for patients with various stages of syphilis. For patients who may have cross reactivity, the specificity of Tp0608 recombinant protein screening is 98.9 %, and the AUC of the ROC curve is 0.99; The specificity of RPR+TPPA screening was 97.3 %, and the AUC of the ROC curve was 0.96. The sensitivity and specificity of Tp0608 recombinant protein in syphilis screening are higher than conventional RPR+TPPA methods, especially in congenital syphilis and primary syphilis.
CONCLUSIONS: The Tp0608 recombinant protein is a promising diagnostic antigen for syphilis screening, but its intracellular location and protective response have not been determined, and further verification is needed.
摘要：
目的：评价重组蛋白抗原Tp0608对梅毒的血清学诊断价值。
方法：纳入406例不同阶段的梅毒患者。建立了重组蛋白抗原Tp0608，并使用ELISA检测梅毒各个阶段的患者。将结果与常规快速血浆反应素试验（RPR）和梅毒螺旋体颗粒凝集试验（TPPA）进行比较。对于不同阶段的梅毒患者，Tp0608重组蛋白和RPRTPPA筛查的敏感性分别为96.6％和93.1％。对于可能有交叉反应性的患者，Tp0608重组蛋白筛选的特异性为98.9%,ROC曲线的AUC为0.99;RPR+TPPA筛查的特异性为97.3%,ROC曲线的AUC为0.96。Tp0608重组蛋白在梅毒筛查中的敏感性和特异性均高于常规RPR+TPPA,尤其是先天性梅毒和原发性梅毒。
结论：Tp0608重组蛋白是梅毒筛查的有前途的诊断抗原，但是它的细胞内位置和保护反应尚未确定，需要进一步核实。
方法：纳入406例不同阶段的梅毒患者。建立了重组蛋白抗原Tp0608，并使用ELISA检测梅毒各个阶段的患者。将结果与常规快速血浆反应素试验（RPR）和梅毒螺旋体颗粒凝集试验（TPPA）进行比较。对于不同阶段的梅毒患者，Tp0608重组蛋白和RPRTPPA筛查的敏感性分别为96.6％和93.1％。对于可能有交叉反应性的患者，Tp0608重组蛋白筛选的特异性为98.9%,ROC曲线的AUC为0.99;RPR+TPPA筛查的特异性为97.3%,ROC曲线的AUC为0.96。Tp0608重组蛋白在梅毒筛查中的敏感性和特异性均高于常规RPR+TPPA,尤其是先天性梅毒和原发性梅毒。
结论：Tp0608重组蛋白是梅毒筛查的有前途的诊断抗原，但是它的细胞内位置和保护反应尚未确定，需要进一步核实。
