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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Syphilis
• Intervention / Treatment: Device: point of care test

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3G 0X2
      • Nine Circles Community Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population for this research comprises individuals seeking care at the Nine Circles Community Health Centre in Winnipeg, Manitoba, Canada. Participants are adults (aged 18 years or older) attending the clinic for routine sexual health care, which includes syphilis testing as part of their standard care. The clinic caters to a diverse urban population which is comprised of newcomers to Canada, indigenous, and LGBTQ2S+ community and receives a significant number of syphilis serology specimens annually, reflecting a broad spectrum of individuals who may present with varying sexual health needs. This setting provides a unique opportunity to evaluate the performance of the DPP® Syphilis Screen & Confirm antibody point-of-care test in a real-world clinical environment

Description

Inclusion Criteria:

• Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care
• Be able to provide informed consent and are a minimum 18 years of age are eligible for this study
• Those who had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them

Exclusion Criteria:

• Those who, at the discretion of the HCP/Research Nurse, appear intoxicated and/or with extreme distress, or confused, will be excluded
• Those below the age of 18 years
• if it has been less than 90 days since their last POCT study visit and they are asymptomatic.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point of Care Test Performance	Sensitivity of POCT: Percentage of participants with laboratory-confirmed active syphilis who are identified as positive by the POCT, Specificity of POCT: Percentage of participants without laboratory-confirmed active syphilis who are identified as negative by the POCT	From start of enrollment to the end of the enrollment period (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary POCT Performance Measures	False Positive Rate: Percentage of participants without active syphilis who test positive by POCT for active syphilis. False Negative Rate: Percentage of participants with active syphilis who test negative by POCT for active syphilis.	From start of enrollment to the end of the enrollment period (12 months)
Comparison of Results by POCT Methodology	Comparison of visual vs micro-reader assisted results	From start of enrollment to the end of the enrollment period (12 months)

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Public Health Agency of Canada (PHAC); Chembio Diagnostic Systems, Inc.
• Investigators: Principal Investigator: Principal Investigator, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: syphilis; Serology; Point of Care Test
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Sexually Transmitted Diseases, Bacterial; Treponemal Infections; Syphilis
• Other Study ID Numbers: HS26266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data and information will not be shared outside agencies for safety and privacy of the participants. Performance of POCT will be evaluated by the research team and the findings may be used for publication; however, any published or disseminated results will omit information that could potentially identify participants (name, date of birth, address and provincial health identifier number).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No