Elaboration of enzyme immunoassay based on recombinant antigens and intended for diagnostics of syphilis.

Enzyme immunoassay (EIA) using recombinant antigens for the detection of Treponema pallidum-specific antibodies in sera of syphilis patients was developed. Four low-molar-mass Treponema antigens (Tp15, Tp17, TmpA, Tp47) were investigated; 17- and 47-kDa proteins were demonstrated as immunodominant as they permitted to obtain the most sensitive EIA. Using a mixture of these proteins a 3rd-generation-EIA kit Dia-Syph was constructed, its sensitivity being 99.4% during tests of 165 sera of syphilitic patients. No false result was obtained on the commercial panel PSS01 (BBI, USA). The specificity of the elaborated test system (99.7%) was determined on 295 sera.