ArticleBMC infectious diseases2026
Developing a multi-antigen fusion protein (Tp15-17-47) serological test to improve neurosyphilis diagnosis.
Article in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesOur 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.
methodsThe 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.
resultsSerum 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.
conclusionsQuantitative 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.
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