感染依赖性抗原Tp0470的鉴定及在梅毒诊断中的应用

Identification and evaluation of the infection phase dependent antigen Tp0470 in syphilis serodiagnosis

为筛选新型梅毒诊断抗原,以改进梅毒早期诊断及预后判断血清学诊断方法,本研究在鉴定Tp0470蛋白为感染依赖性抗原的基础上,建立基于Tp0470的ELISA方法,检测468份临床血清标本,并与TPPA、LZ-ELISA及RPR结果比较,初步评价该蛋白的诊断价值;同时对Tp0470-ELISAA450值与RPR滴度进行相关性分析。结果显示:Tp0470-ELISA的灵敏度和特异度分别为95.32%和95.66%,ROC分析其AUC值为0.907。与TPPA、LZ-ELISA及RPR结果相比,Tp0470-ELISA的符合率分别为95.51%(kappa=0.907)、94.87%(kappa=0.897)、88.67%(kappa=0.771)。Tp0470-ELISA的A450值与RPR滴度的相关系数为0.38,P=0.96。以上结果表明基于Tp0470蛋白的ELISA在梅毒血清学诊断中具有较高的潜在应用价值。

To screen and evaluate the clinical serological diagnosis value about infection phase dependent antigen Tp0470 of treponema pallidum.In this study,Tp0470 and Tp92(negative control)were studied on New Zealand rabbits using live Tp and inactivated Tp inoculated group.468 human serum samples were detected by Tp0470 based ELISA,RPR,LiZhu TM Tp-ELISA and TPPA.Then the spearman rank correlation coefficient between the RPR titer and the A 450 nm values of Tp0470 based ELISA was analyzed.Results showed that Tp0470 was identified as infection phase dependent antigen compared with Tp92.Compared with TPPA,the sensitivity and specificity of Tp0470 based ELISA was 95.32%and 95.66%.Compared with TPPA,LiZhu TM Tp-ELISA and RPR,the agreements of Tp0470 based ELISA was 95.51%with kappa value of 0.907,94.87%with kappa value of 0.897 and 88.67%with kappa value of 0.771,respectively.Moreover,the spearman rank correlation coefficient of the A 450 values of Tp0470 and RPR titer was 0.38(P=0.96),showing no statistical significance.The high sensitivity,specificity and agreements of Tp0470 with TPPA and LiZhu TM Tp-ELISA demonstrated it is promising antigens for syphilis diagnosis.