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.

MedMira Laboratories

Status

Not yet enrolling

Conditions

Treponema Pallidum

Treatments

Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test

Study type

Interventional

Funder types

Industry

Identifiers

NCT06436430

2.0

Details and patient eligibility

About

This study is to test the Multiplo Complete Syphilis (TP/nTP) Antibody Test for its performance in an urban STI clinic using finger-prick obtained whole blood to perform the POCT at the clinic.

Full description

The evaluation will determine the sensitivity and specificity of the POCT results compared to results obtained by the standard conventional syphilis serology tests performed at the Public Health Ontario Laboratory. The evaluation will also include a survey on patients' acceptability of syphilis POCT, and a survey of health care providers for feasibility of its use in the clinic.

Enrollment

600 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Able to provide consent
Patients Requiring Syphilis testing as part of care plan
Patients attending Clinic for follow up appointments following diagnosis with syphilis infection.
Patients 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 provided care
Minimum 16 years of age

Exclusion criteria