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

Primary Purpose

Syphilis Infection, Syphilis, Early Syphilis, Symptomatic

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Reveal TP (Syphilis) Antibody Test
Sponsored by
MedMira Laboratories Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syphilis Infection focused on measuring Rapid Vertical Flow (RVF), Reveal TP, Syphilis, POCT, MedMira

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • BCCDC STI ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2023
Last Updated
October 3, 2023
Sponsor
MedMira Laboratories Inc.
Collaborators
Public Health Agency of Canada (PHAC)
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1. Study Identification

Unique Protocol Identification Number
NCT05831098
Brief Title
Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedMira Laboratories Inc.
Collaborators
Public Health Agency of Canada (PHAC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis Infection, Syphilis, Early Syphilis, Symptomatic
Keywords
Rapid Vertical Flow (RVF), Reveal TP, Syphilis, POCT, MedMira

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test
Arm Type
Experimental
Arm Description
Participants are tested with investigational devices and conventional syphilis serology tests.
Intervention Type
Device
Intervention Name(s)
Reveal TP (Syphilis) Antibody Test
Other Intervention Name(s)
Reveal TP
Intervention Description
All subjects tested with both investigational devices and conventional syphilis serology tests.
Primary Outcome Measure Information:
Title
To determine the accuracy of Reveal TP (Syphilis) Antibody Test
Description
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.
Time Frame
1 patient visit of approximately 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer MacLellan
Phone
9024501588
Email
jennifer.maclellan@medmira.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troy Grennan, Dr
Organizational Affiliation
British Columbia Center for Disease Control (BCCDC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymond Tsang, Dr
Organizational Affiliation
National Microbiology Laboratory Branch, Public Health Agency of Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
BCCDC STI Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benita Okocha

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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