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

Sponsor

MedMira Laboratories Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05831098

Collaborator

Public Health Agency of Canada (PHAC) (Other)

1,000

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Syphilis Infection Syphilis Early Syphilis, Symptomatic	Device: Reveal TP (Syphilis) Antibody Test	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

The result of the Reveal TP (Syphilis) Antibody Test will not be revealed to the participant.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test Participants are tested with investigational devices and conventional syphilis serology tests.	Device: Reveal TP (Syphilis) Antibody Test All subjects tested with both investigational devices and conventional syphilis serology tests. Other Names: Reveal TP

Arm

Intervention/Treatment

Experimental: Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

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

Device: Reveal TP (Syphilis) Antibody Test

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

Other Names:

Reveal TP

Outcome Measures

Primary Outcome Measures

To determine the accuracy of Reveal TP (Syphilis) Antibody Test [1 patient visit of approximately 30 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 2: No additional inclusion criteria
Group 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment
Group 4: No additional inclusion criteria
Those who 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 the four categories 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 number of patients showing up.

Exclusion Criteria:

• 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 2: No additional exclusion criteria
Group 3: Current symptoms that could be consistent with early syphilis.
Group 4: Current symptoms that could be consistent with early syphilis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

MedMira Laboratories Inc.
Public Health Agency of Canada (PHAC)

Investigators

Principal Investigator: Troy Grennan, Dr, British Columbia Center for Disease Control (BCCDC)
Principal Investigator: Raymond Tsang, Dr, National Microbiology Laboratory Branch, Public Health Agency of Canada