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.
Single group
Diagnostic test: Determine™ Syphilis Advanced test
Diagnostic testThe Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.
To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users.
The diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test will be evaluated versus laboratory reference testing.
To compare the performance of the Determine™ Syphilis Advanced test with two commercially available similar tests
The Determine™ Syphilis Advanced test will be compared with two commercially available tests. These tests are the TPPA test (SERODIA-TPPA, Fujirebio) and the Determine™ Syphilis TP (Abbott) test.
To evaluate the usability through completion of a user experience questionnaire.
A user experience questionnaire will be completed by study healthcare staff. The users will evaluate the ease of use, and confidence in correct performance, of various test steps and result interpretation. The response options are ranked on a scale of 1-5. where option 1 stands for Very easy, or Very confident as applicable, and 5 stands for Very Difficult, or Very unsure as applicable.
To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration .
Venous whole blood, serum and plasma will be stored at 2-8 degrees Celsius during 7 days before testing with Determine™ Syphilis Advanced.
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