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New Diagnostic Biomarker for Syphilis - 10/12/2015







New Diagnostic Biomarker for Syphilis
Single most sensitive and specific syphilis antigen known at this time.

Research conducted at the University of Victoria (UVic) in Canada has led to the discovery of a new syphilis (Treponema pallidum) biomarker called Tp0453 which has shown remarkable sensitivity (98%) and specificity (100%) (Van Voorhis, 2003 and Smith, 2013).

Tp0453 is a 30kDa outer-membrane protein that was discovered through computer analyses on the published T. pallidum genome. Initial studies demonstrated a diagnostic accuracy of 100% especially during early-stage infections when the risk of syphilis transmission is at its highest. The high specificity is thought to be due to the unique nature of Tp0453, which has no homologs in bacteria. In contrast, existing syphilis assays have a relatively low accuracy (~90% specificity) due to false positive reactions with cross-reactive infections (Leptospira spp., Borrelia burgdorferi, Helicobacter pylori, Epstein-Barr virus, hepatitis B virus, hepatitis C virus, or cytomegalovirus).

In a study conducted by UVic using 169 serum samples from primary, secondary, and latent stages of infection, Tp0453 (incorporated into an ELISA assay) was directly compared against a commercial assay for syphilis (Smith, 2013). Tp0453 was found to have an equivalent sensitivity (98%) but a significantly higher specificity (100% vs 90%).

Although several highly immunogenic lipoproteins have already been identified as diagnostic targets for syphilis, including Tp17, Tp15, Tp41, Tp44.5 (TmpA), Tp47, and Tp35 (TmpC), no single marker has shown high sensitivity and specificity across all stages of the disease until the discovery of Tp0453. Meridian Life Science holds the license to produce this antigen and significant process improvements have increased the scale, performance and quality.

Smith et al. (2013). New Proteins for a New Perspective on Syphilis Diagnosis.  J Clin Microbiol.; 51(1): 105–111

Van Voorhis et al. (2003) Herein Tp0453 has 100% Sensitivity and 100% Specificity in Syphilis Serodiagnosis. J. Clin. Microbiol.41:3668-74.

New Syphilis Biomarker – Tp0453


• E. coli (soluble protein), major band migrates in the
  region of 31kDa
• Buffer: Hepes and NaCl
• Concentration ~ 1mg/ml

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