Performance of novel infection phase-dependent antigens in syphilis serodiagnosis and treatment efficacy determination.

OBJECTIVE

The objective of this study was to screen new antigens for syphilis serodiagnosis.

METHODS

First, we determined whether the Treponema pallidum proteins Tp0971, Tp0768 and Tp0462 were infection phase-dependent antigens by observing serum reactivity differences in New Zealand rabbits infected with activated or inactivated T. pallidum. A non-infection phase-dependent antigen, the Tp92 membrane protein, was used as the negative control. Next, Tp0971-, Tp0768- and Tp0462-based ELISA was performed on 2138 human serum samples and compared with the T. pallidum passive particle agglutination assay (TPPA) and LiZhu™ Tp-ELISA. In addition, another 60 paired serum samples from patients at follow-up were analysed to evaluate the relationships between titre changes and differences in the A450 nm values of the Tp0971, Tp0768, Tp0462 and Tp92 antibodies measured by ELISA.

RESULTS

Compared with Tp92 (negative control), Tp0971, Tp0768 and Tp0462 were determined to be infection phase-dependent antigens. Compared with those of the TPPA, the sensitivities of Tp0971-, Tp0768- and Tp0462-based ELISA were 96.4%, 96.9% and 93.0%, respectively, and the specificities were 97.7%, 95.4% and 98.9%, respectively, resulting in consistencies of 97.1%, 96.2% and 95.9%, respectively. Compared with those of the LiZhu™ Tp-ELISA, the consistencies of Tp0971-, Tp0768- and Tp0462-based ELISA were 95.1%, 94.2% and 94.0%, respectively, with kappa values of 0.902, 0.884 and 0.880, respectively. Tp0971, Tp0768 and Tp0462 demonstrated high sensitivities and specificities, as well as high conformity to the TPPA and LiZhu™ Tp-ELISA. Moreover, a significantly positive Spearman rank correlation coefficient (0.82,*P < 0.05) was found between the difference in the A450 nm values of the Tp0971 antibody and the RPR titre change.

CONCLUSION

The infection phase-dependent antigens Tp0971, Tp0768 and Tp0462 are promising for syphilis diagnosis, and Tp0971 may be utilized to monitor curative effects during syphilis treatment.