Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test

Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test

This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.

Branch #1: Participants known to have an HIV infection - Inclusion criteria:

• Previously documented positive HIV serology

Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:

• Documented positive syphilis serology

Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:

• No documented positive HIV or syphilis serology

Exclusion criteria:

Unable to speak and understand English