Sexually Transmitted Diseases (STDs)

Categories of serological testing for syphilis

1. Treponemal tests which are aimed at detecting an antigen or an antibody to T. pallidum . Examples include EIA assays that detect IgG and/or IgM and IgA antibodies to T. pallidum . 2. Non-treponemal tests which look for indirect indications of the infection such as the presence of cardiolipins (a mitochondrial membrane lipid), which are released when a treponeme bacteria damages cells. Since these tests do not detect the bacteria directly they usually require confirmation testing.

The T. pallidum genome is 1.14 Mb and encodes a putative 1,041 proteins (Genome Sequencing Project). Different strains of T. pallidum (Tp) may express different repertoires of Tp proteins as demonstrated by various immunologic studies (Leader, B. et al. (2003) Infect. Immun. 71:6054-6057 ). In the past few years, several highly immunogenic lipoproteins have been identified as diagnostic targets throughout all stages of a syphilis infection, including Tp17, Tp15, Tp44.5 (TmpA), Tp47, Tp41, Tp35 (TmpC) and Tp0453. Specifically, early immune responses have been shown to be against Tp47 and some of the flagellar proteins, followed by Tp15 and Tp17. Tp0453 has also been shown to be a promising diagnostic marker with very high sensitivity in early detection. For this reason, several commercial tests have been developed using a combination of these immunogenic antigens and have proven to be highly sensitive and specific for the diagnosis of an active or latent syphilis infection. Also recent developments include rapid formats that can be performed at the point of care, including agglutination tests using latex particles coated with treponemal antigen or lateral flow assays.

Protein T. Pallidum Genome Tp0453 Outer-membrane protein 30 kDa Tp15 (Tp0171) Membrane-associated 15 kDa lipoprotein Tp17 (Tp0435) Membrane-associated 17 kDa lipoprotein Tp41 41 kDa homolog of galactose- glucose-binding protein Tp47 (Tp0574) Membrane-associated 47 kDa lipoprotein with carboxypeptidase properties

TmpA/ Tp44.5 (Tp0768)

Membrane lipoprotein 42 kDa

Reagents for serology testing T. pallidum p15 Recombinant Antigens

Suitable for ELISA, Lateral Flow and Western Blot Antibody Detection Assays

R8A101

• Represents the full length p15 protein • Produced in E. coli and fused with a -gal tag at the N-terminus (>95% pure) • Molecular weight of 60kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol • Mosaic protein representing immunodominant regions of p15 • Produced in E. coli and fused with a 6-His tag • Molecular weight of 19kDa • Buffer: 150 mM Imidazole, 25 mM Sodium Phosphate, pH 8.0 containing 150 mM NaCl, 50% Glycerol

R01531

Suitable for ELISA Antibody Detection Assays

R8A201 T. pallidum p17 Recombinant Antigens

Suitable for ELISA, Lateral Flow and Western Blot Antibody Detection Assays

• Represents the full length p17 protein • Produced in E. coli and fused with a -gal tag at the N-terminus (>95% pure) • Molecular weight of 63kDa • Buffer: 8 M Urea, 20 mM Tris-HCl, pH 8.0 containing 10 mM -Mercaptoethanol