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.

NCT06586905 | Recruiting

• 1 other identifier: REB 2023-034P
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and stillbirths, the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder. Indeed during a number of federal, provincial and territorial meetings on the control of syphilis outbreaks in Canada, requests for POCT to detect syphilis infections have repeatedly come up. However, before a POCT can be widely used, research to find out if it is accurate and reliable is necessary. This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in an urban clinic (Sexual Health Clinic) in Ottawa, Ontario, Canada and compare its performance in parallel with the usual testing method (the gold standard, i.e. conventional syphilis serology testing).

Conditions

Syphilis; Treponema Pallidum

Keywords

Syphilis; TP/nTP; Multiplo Complete Syphilis (TP/nTP) Antibody Test; MedMira; Treponema pallidum; rapid test; point of care

Outcome Measures

Primary Outcomes (1)

• To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test

  For each enrolled subject, Multiplo Complete Syphilis (TP/nTP) Antibody Test will be used to test fingerstick whole blood from the patient. A venipuncture whole blood sample will also be drawn from the patient and will be tested using conventional serological testing methods to determine patient status.

  1 patient visit of appoximately 30 minutes

Study Arms (1)

Multiplo Complete Syphilis (TP/nTP) Antibody Test

EXPERIMENTAL

Participants are tested with investigational devices and conventional syphilis serology tests

Device: Medical Device

Interventions

Medical Device DEVICE

Multiplo Complete Syphilis (TP/nTP) Antibody Test

Multiplo Complete Syphilis (TP/nTP) Antibody Test

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Those who, at the discretion of the HCPs/research co-ordinator, appear intoxicated and/or with extreme distress, or confused, will be excluded from this research because they would not be able to provide informed consent to participate, as well as those below the age of 16 years.

Sponsors & Collaborators

• MedMira Laboratories Inc.: lead
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (1)

Sexual Health Clinic

Ottawa, Ontario, K1N 1B3, Canada

RECRUITING

Related Publications (1)

• O'Byrne P, Dillabough R, Whyte K, Orser L, Tran V, Duvvuri VR, Tsang R. Evaluating the MedMira Multiplo(R) Complete Syphilis (TP/nTP) antibody test in a sexually transmitted infection clinic in Ottawa, Canada: increased rapid diagnosis and improved antibiotic stewardship. BMC Infect Dis. 2025 Dec 8. doi: 10.1186/s12879-025-12263-w. Online ahead of print.

  PMID: 41361278 DERIVED

MeSH Terms

Conditions

Syphilis; Treponemal Infections

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Jennifer MacLellan

CONTACT

902-450-1588; support@medmira.com

Kayla Turner

CONTACT

902-450-1588

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 26, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)