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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2026-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Syphilis Treponema Pallidum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multiplo Complete Syphilis (TP/nTP) Antibody Test

Participants are tested with investigational devices and conventional syphilis serology tests

Group Type EXPERIMENTAL

Medical Device

Intervention Type DEVICE

Multiplo Complete Syphilis (TP/nTP) Antibody Test

Interventions

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Medical Device

Multiplo Complete Syphilis (TP/nTP) Antibody Test

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes