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

Study Overview
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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).

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.

Official Title
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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

Conditions
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Syphilis Infection, Syphilis, Early Syphilis, Symptomatic

Intervention / Treatment
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* Device: Reveal TP (Syphilis) Antibody Test


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Diagnostic: Reveal TP (Syphilis) Antibody Test<br>Participants are tested with investigational devices and conventional syphilis serology tests. | Device: Reveal TP (Syphilis) Antibody Test<br>* All subjects tested with both investigational devices and conventional syphilis serology tests.<br>* Other names: Reveal TP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Vertical Flow (RVF), Reveal TP, Syphilis, POCT, MedMira