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

University of Manitoba

Status: Enrolling

Conditions: Syphilis

Treatments: Device: point of care test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06927843

HS26266

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.