NCT05831098

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

Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT to Diagnose Infectious Syphilis in Participants Attending the BCCDC's STI Clinic in Vancouver, BC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: MedMira Laboratories Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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).

Detailed description

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). The healthcare professional will advise patients about the study, and with their permission refer them to research staff for recruitment. Should patients choose to participate in the study they will be asked to provide consent to have a few drops of blood sample obtained through a finger prick to be used in the POCT. POCT results will not be provided to participants and this will be explained in both the recruitment script and informed consent form. A sample of 5 to 10 ml venous whole blood will also be obtained for the conventional syphilis serology testing which is part of the routine for care of the four categories of patients (regardless of this research). This research will take approximately 15 to 30 minutes and will be on top of the regular care that patients will receive in the clinic. Upon completing the tests, participants will be asked to complete a brief feedback survey to assess patients' acceptability of syphilis POCT.

Conditions

• Syphilis Infection
• Syphilis
• Early Syphilis, Symptomatic

Interventions

Type	Name	Description
DEVICE	Reveal TP (Syphilis) Antibody Test	All subjects tested with both investigational devices and conventional syphilis serology tests.

Timeline

• Start date: 2023-05-12
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2023-04-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Canada