Canada's first oral HIV self-test approved for sale

Health Canada approved OraSure's OraQuick oral HIV self-test for sale in Canada; St. Michael's MAP Centre will distribute the saliva-based test, which returns results in about 20 minutes.

Health Canada has approved the OraQuick oral HIV self-test, allowing an at-home saliva test to be sold in Canada. U.S.-based OraSure Technologies announced the approval and the MAP Centre for Urban Health Solutions at St. Michael's Hospital in Toronto will be the exclusive distributor. The test uses a swab along the top and bottom gums and processes in about 20 minutes. This approval adds a non-blood option to the existing at-home finger-prick test first approved for Canada in 2020. Key facts: - OraQuick is the first oral HIV self-test approved for sale in Canada and was previously approved in the U.S. in 2012 and recommended by WHO in 2016. - The test uses a saliva swab, is processed in a plastic cartridge for roughly 20 minutes, and displays results with a control line and a test line (one line negative, two lines positive). - The MAP Centre at St. Michael's will begin taking online orders and plans to ship tests in the coming weeks as distributor. - Antibody tests like OraQuick generally detect HIV about 23 to 90 days after exposure, according to the U.S. Food and Drug Administration, and studies show oral tests are generally highly accurate. - Clinicians in the article say any positive self-test result should be confirmed by a laboratory blood test, and they note that access to rapid follow-up care and support is important for people who receive a positive result. - The test is expected to cost about $15 to $20 each; experts quoted in the article said cost can be a barrier for vulnerable groups and that some provinces have funded self-testing programs previously. Summary: The approval provides a less invasive, at-home testing option that may reach people who are reluctant to use blood-based kits and could help identify some of the estimated 7,000 Canadians living with undiagnosed HIV. Distribution will begin through St. Michael's MAP Centre, and broader uptake as well as any additional public funding remain undetermined at this time.