Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis

The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen \& Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba. The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis? Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit. Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience. Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits

NCT Number	NCT06927843
Lead Sponsor	University of Manitoba Collaborators: Public Health Agency of Canada (PHAC), Chembio Diagnostic Systems, Inc.
Conditions	Syphilis
Enrollment	600 participants
Start Date	2025-03-05
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-04