Production and evaluation of the clinical efficacy of the recombinant T. pallidum antigen Tp0453 for syphilis diagnosis

Abstract

Goal. Production of a recombinant T. pallidum antigen Tp0453 and the evaluation of the efficacy of its clinical use for syphilis diagnosis. Materials and methods. To produce the target recombinant T. pallidum antigen, a Tp0453 protein coding fragment of the DNA of the causative agent of syphilis, was cloned into the pET28а vector. Heterological expression of the recombinant T. pallidum antigen was performed in the E. coli BL21 (DE3) strain. The recombinant Tp0453 six-histidine-tagged protein was purified by the metal-chelate affinity chromatography. The resulting homogenous recombinant T. pallidum Tp0453 protein was used to reveal specific IgG antibodies in the serum of syphilis patients using a microarray technology. Results and conclusion. The use of the resulting recombinant protein enabled authors to reveal anti- T. pallidum antibodies in the blood serum of patients suffering from syphilis (primary, secondary, early and late latent syphilis). None of the uninfected controls had a significant reactivity to the recombinant Tp0453. These data allow to propose, that the recombinant protein Tp0453 show promise for laboratory diagnosis of syphilis. The introduction of Tp0453 antigen into the test systems for diagnosis of syphilis (ELISA, immunoblotting or microarray) increases the potential of serodiagnosis of this disease due to the broader range of the revealed antitreponemal antibodies.