MedMira Multiplo rapid syphilis antibody test used at an Ottawa sexual health clinic
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario. The MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test is Authorized for Investigational Use.
This will test the MedMira Multiplo point-of-care syphilis antibody test on people aged 16 and older who are getting syphilis testing at an Ottawa sexual health clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | MedMira Laboratories Inc. Industry-sponsored |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06586905 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 16 or older attending the Ottawa Sexual Health Clinic who require syphilis testing and can give informed consent.
Not a fit: People who are not undergoing syphilis testing or who cannot provide informed consent (for example, those who appear intoxicated, extremely distressed, or confused) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the test could provide faster on-site diagnosis and enable earlier treatment and public health action to limit transmission and congenital cases.
How similar studies have performed: Other point-of-care syphilis tests, including dual treponemal/non-treponemal approaches, have shown mixed but promising results, while real-world data for this specific MedMira device are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ottawa, Ontario
- Sexual Health Clinic — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Jennifer MacLellan
- Email: support@medmira.com
- Phone: 902-450-1588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.