Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT (NCT05831098) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT
Canada600 participantsStarted 2023-05-12
Plain-language 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).
Who can participate
Age range19 Years
SexALL
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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: Curre…
What they're measuring
1
To determine the accuracy of Reveal TP (Syphilis) Antibody Test
Timeframe: 1 patient visit of approximately 30 minutes