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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-12-06

Brief Summary

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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).

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Detailed Description

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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

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Syphilis Infection Syphilis Early Syphilis, Symptomatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test

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

Group Type EXPERIMENTAL

Reveal TP (Syphilis) Antibody Test

Intervention Type DEVICE

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

Interventions

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Reveal TP (Syphilis) Antibody Test

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

Intervention Type DEVICE

Other Intervention Names

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Reveal TP

Eligibility Criteria

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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 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment

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 3: Current symptoms that could be consistent with early syphilis.
* Group 4: Current symptoms that could be consistent with early syphilis.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes