Development of Syphilis Screen & Confirm Assay

Syphilis is a sexually transmitted infection that remains a global health threat. The World Health Organization estimates that more than 10.6 million new cases are reported in adults annually worldwide. Previously, the only commercially available serological test for syphilis determined lifetime exposure to Treponema pallidum, the bacterium that causes syphilis. This test was not able to distinguish between an active syphilis infection verses a lifetime exposure to the bacteria. In addition, these tests were administered in laboratory settings, requiring equipment and trained personnel for result interpretation. Results could take several days to receive, further delaying treatment.

CDC Investigator, Dr. Arnold Castro, in collaboration with ChemBio developed the DPP® Syphilis Screen & Confirm Assay. This diagnostic tool is a rapid dual test that can confirm whether a patient has been previously exposed to syphilis and if the infection is active. This point-of-care test offers results that are easy to interpret with a total test time of 20 minutes, giving clinicians an opportunity to initiate treatment immediately within a single visit. The test is a two-step procedure that requires no special equipment and is ideal for field use in developing countries. The DPP Syphilis Screen & Confirm Assay is licensed to ChemBio and is commercially available in 6 countries including Austria, Chile, China, Guatemala, South Africa, and Sweden. CDC holds 10 US and international patents related to this technology.