A Cross-sectional Study to Evaluate the MedMira Multiplo4 Complete Syphilis Antibody Test Compared to Standard Syphilis Testing in Participants 16 Years and Older at a Sexual Health Clinic

What this Trial Is About

Researchers are evaluating the accuracy and reliability of the MedMira Inc. Multiplo4 Complete Syphilis (TP/nTP) Antibody Test (a point-of-care test or POCT) to diagnose infectious syphilis. This study responds to a rise in infectious syphilis cases in Canada, especially among heterosexuals and females of childbearing age, which has led to increased congenital syphilis and stillbirths. The goal is to compare this rapid test's performance to the standard syphilis serology testing used in clinical settings. Participants attending a sexual health clinic in Ottawa for routine syphilis testing will undergo testing with both the investigational Multiplo Complete Syphilis Antibody Test and conventional syphilis serology tests. The study involves a single visit lasting approximately 30 minutes during which both tests will be conducted in parallel to evaluate the new device's sensitivity and specificity. During the visit, participants will provide informed consent and be tested using both methods. Researchers will measure the accuracy of the investigational test compared to the gold standard. The study is designed to include individuals 16 years and older attending the clinic for syphilis testing, including follow-up visits. The study does not involve masking or randomization and aims to complete data collection by July 2026.

A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.