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.

Not Applicable

Active, not recruiting

• Conditions: Syphilis
• Interventions: Device: Medical Device

• Registration Number: NCT06586905
• Lead Sponsor: MedMira Laboratories Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-26
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2025-05
• Primary Completion: 2025-05-20
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Completion: 2026-02-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care, who are able to provide informed consent and are a minimum 16 years of age are eligible for this study. This includes patients attending the Clinic for follow-up appointments following diagnosis with syphilis infection. Those who have 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. Once it has been determined that the exclusion criteria does not apply to a patient, the recruitment of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of Clinic staff or large numbers of patients in attendance.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiplo Complete Syphilis (TP/nTP) Antibody Test	Medical Device	Participants are tested with investigational devices and conventional syphilis serology tests

Primary Outcome Measures

Name	Time	Method
To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test	1 patient visit of appoximately 30 minutes	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.

Trial Locations

Locations (1)

Sexual Health Clinic; 🇨🇦 Ottawa, Ontario, Canada