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

NCT06927843 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-05-04

No results posted yet for this study

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

Conditions

  • Syphilis

Interventions

DEVICE

point of care test

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

Sponsors & Collaborators

  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV

  • Chembio Diagnostic Systems, Inc.

    collaborator INDUSTRY

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Principal Investigator · University of Manitoba

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927843 on ClinicalTrials.gov