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Objectives <p>Our previous research identified a luciferase immunosorbent assay (LISA) for detecting serum antibodies against Tp17 and Tp47 as a potential tool for diagnosing neurosyphilis (NS). In this study, we developed a serological test based on a multi-antigen fusion protein (Tp15–17–47) to simplify the detection process and improve the diagnostic accuracy for NS.</p> Methods <p>The Tp15, Tp17, and Tp47 genes were amplified separately by polymerase chain reaction (PCR) and assembled into a fusion gene coding for a tripartite fusion protein antigen using overlap PCR. This recombinant Tp15-17-47 antigen was used retrospectively to detect serum anti-Tp15-17-47 IgG antibodies in 434 HIV-negative patients suspected of NS from cohorts in Beijing and Guangzhou. Two diagnostic prediction models were developed using stepwise logistic regression.</p> Results <p>Serum anti-Tp15-17-47 IgG antibodies demonstrated moderate diagnostic capability for NS in the development cohort, with an area under the curve (AUC) of 0.791 (95% CI: 0.735–0.846). An optimized NS prediction model substituting anti-Tp15-17-47 antibodies for TRUST/RPR outperformed the base NS diagnostic model. The optimized model achieved an AUC of 0.877 (95% CI: 0.835–0.919) compared to 0.843 (95% CI: 0.795–0.890) for the base model in the development cohort (<i>p</i> = 0.035). This superior performance was confirmed in the validation cohort (AUC: 0.880, 95% CI: 0.827–0.933 vs. 0.792, 95% CI: 0.726–0.859; <i>p</i> &lt; 0.001). Decision curve analysis (DCA) revealed that the optimized model provided greater net benefit than the base model across threshold probabilities ranging from 0.10 to 0.95 in both cohorts.</p> Conclusions <p>Quantitative profiling of serum IgG targeting the recombinant treponemal antigen Tp15-17-47, along with its diagnostic model, exhibited robust discriminatory power for neurosyphilis diagnosis, which supports the viability of replacing lumbar puncture with this less invasive serological strategy for neurosyphilis ascertainment.</p>

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Developing a multi-antigen fusion protein (Tp15-17-47) serological test to improve neurosyphilis diagnosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月23日

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  • Ziliang Deng,
  • Wenjia Weng,
  • Yuanyuan He,
  • Yan Xu,
  • Tayier Tuerhong,
  • Lin Yang,
  • Bingbing Song,
  • Xiaohui Zhang,
  • Ligang Yang,
  • Liuyuan Wang,
  • Renaguli Maimaiti,
  • Gang Zheng,
  • Shixing Tang,
  • Wujian Ke,
  • Haiying Wang

摘要

Objectives

Our previous research identified a luciferase immunosorbent assay (LISA) for detecting serum antibodies against Tp17 and Tp47 as a potential tool for diagnosing neurosyphilis (NS). In this study, we developed a serological test based on a multi-antigen fusion protein (Tp15–17–47) to simplify the detection process and improve the diagnostic accuracy for NS.

Methods

The Tp15, Tp17, and Tp47 genes were amplified separately by polymerase chain reaction (PCR) and assembled into a fusion gene coding for a tripartite fusion protein antigen using overlap PCR. This recombinant Tp15-17-47 antigen was used retrospectively to detect serum anti-Tp15-17-47 IgG antibodies in 434 HIV-negative patients suspected of NS from cohorts in Beijing and Guangzhou. Two diagnostic prediction models were developed using stepwise logistic regression.

Results

Serum anti-Tp15-17-47 IgG antibodies demonstrated moderate diagnostic capability for NS in the development cohort, with an area under the curve (AUC) of 0.791 (95% CI: 0.735–0.846). An optimized NS prediction model substituting anti-Tp15-17-47 antibodies for TRUST/RPR outperformed the base NS diagnostic model. The optimized model achieved an AUC of 0.877 (95% CI: 0.835–0.919) compared to 0.843 (95% CI: 0.795–0.890) for the base model in the development cohort (p = 0.035). This superior performance was confirmed in the validation cohort (AUC: 0.880, 95% CI: 0.827–0.933 vs. 0.792, 95% CI: 0.726–0.859; p < 0.001). Decision curve analysis (DCA) revealed that the optimized model provided greater net benefit than the base model across threshold probabilities ranging from 0.10 to 0.95 in both cohorts.

Conclusions

Quantitative profiling of serum IgG targeting the recombinant treponemal antigen Tp15-17-47, along with its diagnostic model, exhibited robust discriminatory power for neurosyphilis diagnosis, which supports the viability of replacing lumbar puncture with this less invasive serological strategy for neurosyphilis ascertainment.