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

Launched by MEDMIRA LABORATORIES INC. · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the Reveal® TP (Syphilis) antibody POCT, designed to quickly check for syphilis infection. Researchers want to see how well this new test works compared to the standard testing method currently used in an urban sexual health clinic in Vancouver, British Columbia. They are looking for adult patients aged 19 and older who are visiting the clinic for routine sexual health care and need syphilis testing. Participants can come from different backgrounds, including those with no prior history of syphilis and those who have been in contact with someone diagnosed with syphilis in the past year.

If you choose to participate, you can expect to receive both the new test and the standard test during your visit. The study is open to all genders, and while those with certain symptoms will be excluded to ensure accurate results, anyone else seeking routine care is encouraged to join. This trial aims to improve the way syphilis is diagnosed, ultimately helping healthcare providers offer better care to patients.

Gender

ALL

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.