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Health Canada has licensed the OraQuick oral HIV self-test, marking the first approval in Canada for an at-home, non-blood oral swab that delivers results in about 20 minutes.
OraSure Technologies’ kit, used in the United States since 2012 and recommended by the World Health Organization in 2016, will be distributed in Canada by a team led by Dr.
Sean Rourke at St.
Michael’s Hospital, which acted as the exclusive distributor and ran clinical outreach trials.
Research cited by regulators shows oral-test performance is statistically equivalent to blood-based self-tests.
The rollout follows a national trial that reached roughly 100,000 people and involved community organisations serving African, Caribbean and Black communities, gay and bisexual men, people who use drugs, and Indigenous peoples.
HIV diagnoses in Canada rose from about 1,800 in 2022 to 2,434 in 2023 before falling to 1,826 in 2024; Manitoba and Saskatchewan continue to have rates well above the national average.
Public-health experts say widespread impact will depend on government funding to supply tests for free and on efforts to link people with positive results to confirmatory testing and care.







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