This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.
12 years of age or older.
The participant has confirmed previous / current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.
The participant agrees to provide written informed consent.
The participant agrees to complete all aspects of the study.
Participant has already participated in this study on a previous occasion.
Participant is deemed vulnerable and / or unfit for participation in the study by the Investigator.
Participant is unwilling or unable to provide informed consent.
Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.