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ACTIVE NOT RECRUITING
NCT06927843

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

Sponsor: University of Manitoba

View on ClinicalTrials.gov

Summary

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

Official title: A Cross-sectional Investigational Study 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2025-03-05

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

point of care test

DPP Syphilis Screen and Confirm antibody point-of-care-test (POCT)

Locations (1)

Nine Circles Community Health Centre

Winnipeg, Manitoba, Canada