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

University of Manitoba600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Syphilis

Interventions

point of care testDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: From start of enrollment to the end of the enrollment period (12 months)

Secondary Outcomes

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.

Time frame: 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

Time frame: From start of enrollment to the end of the enrollment period (12 months)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts