MedMira Multiplo rapid syphilis antibody test used at an Ottawa sexual health clinic

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional study compares the MedMira Multiplo® Complete Syphilis (TP/nTP) antibody point-of-care test with the clinic’s usual laboratory testing performed in parallel. Participants aged 16 and older who present for routine sexual health care and require syphilis testing will be offered the POCT in the clinic and have standard tests drawn at the same visit. The study will measure the POCT’s sensitivity, specificity, and practical utility for diagnosing infectious syphilis. Results will be analyzed to see how well the device identifies active infection compared with standard laboratory algorithms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care, who are able to provide informed consent and are a minimum 16 years of age are eligible for this study. This includes patients attending the Clinic for follow-up appointments following diagnosis with syphilis infection. Those who have 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 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 numbers of patients in attendance.

Exclusion Criteria:

* Those who, at the discretion of the HCPs/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, as well as those below the age of 16 years.

Where it's running

• Sexual Health Clinic
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Jennifer MacLellan
• Email: support@medmira.com
• Phone: 902-450-1588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.