Treponema Pallidum Clinical Trial
Official title:
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 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.
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. ;