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Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
Sponsor: Nova Scotia Health Authority
Summary
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.
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-06
Completion Date
2026-12
Last Updated
2025-05-01
Healthy Volunteers
Yes
Interventions
INSTI HIV/syphilis Point of Care Self-Test Administration
The INSTI Human Immunodeficiency Virus (HIV)/syphilis POCT is a rapid, single-use, flow-through immunoassay that is Health Canada-approved as a screening test for detecting antibodies to HIV1/2 and syphilis using a fingerstick blood sample.