Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT

NCT05831098 | Completed

• 1 other identifier: MM062TP2022
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

Conditions

Syphilis Infection; Syphilis; Early Syphilis, Symptomatic

Keywords

Rapid Vertical Flow (RVF); Reveal TP; Syphilis; POCT; MedMira

Outcome Measures

Primary Outcomes (1)

• To determine the accuracy of Reveal TP (Syphilis) Antibody Test

  For each enrolled subject, Reveal TP (Syphilis) 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 approximately 30 minutes

Study Arms (1)

Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

EXPERIMENTAL

Participants are tested with investigational devices and conventional syphilis serology tests.

Device: Reveal TP (Syphilis) Antibody Test

Interventions

Reveal TP (Syphilis) Antibody Test DEVICE

All subjects tested with both investigational devices and conventional syphilis serology tests.

Also known as: Reveal TP

Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 19 years of age and above attending the BCCDC STI Clinic in Vancouver, British Columbia for routine sexual health care and requiring syphilis testing as part of this care are eligible for this study.
• Additionally, for each participant category:
• Group 1: No known (i.e. self-reported or laboratory documented history of syphilis) prior history of syphilis.
• Group 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment

You may not qualify if:

• Minors, and those who, at the discretion of the health care provider/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.
• Additionally, for each participant category:
• Group 1: Current symptoms that could be consistent with early syphilis.
• Group 3: Current symptoms that could be consistent with early syphilis.
• Group 4: Current symptoms that could be consistent with early syphilis.

Sponsors & Collaborators

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

Study Sites (1)

BCCDC STI Clinic

Vancouver, British Columbia, V5Z 4R4, Canada

Location

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; 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

Study Officials

• Troy Grennan, Dr

  British Columbia Center for Disease Control (BCCDC)

  PRINCIPAL INVESTIGATOR

• Raymond Tsang, Dr

  National Microbiology Laboratory Branch, Public Health Agency of Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The result of the Reveal TP (Syphilis) Antibody Test will not be revealed to the participant.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 12, 2023
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 26, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)