The self-test is Canada’s first oral HIV self-test, providing results in 20 minutes using an oral swab.
OraSure Technologies Inc has received a license from Health Canada for its OraQuick HIV Self-Test, marking the first oral HIV self-test available in Canada, according to a release from the company.
The point-of-care rapid antibody test—already approved by the US Food and Drug Administration for individuals aged 14 and older—detects antibodies for both HIV-1 and HIV-2, enabling individuals to determine their HIV status with an oral swab in as little as 20 minutes. The test can be used in various settings, including at home, pharmacies, or community-based testing events.
“Expanding access to HIV testing options is a critical component in the global effort to end the HIV epidemic,” says Carrie Eglinton Manner, president and CEO of OraSure, in a release. “Early diagnosis and linkage to care remain essential for improving health outcomes.”
Addressing Canada’s HIV Testing Gap
Data from the Public Health Agency of Canada show there were 1,826 new HIV diagnoses in 2024 (not including Quebec), for a national rate of 5.7 per 100,000 people. Some provinces experience significantly higher rates, with Manitoba and Saskatchewan reporting rates three to four times the national average. Manitoba recorded the highest HIV rate in Canada at 19.5 per 100,000 people, followed by Saskatchewan at 18.6 per 100,000.
More than 7,000 people in Canada are estimated to be living with HIV but remain undiagnosed and are not receiving life-saving treatments, according to Dr Sean B Rourke, director of REACH Nexus housed at MAP Centre for Urban Health Solutions at St Michael’s Hospital.
“This oral fluids test presents the next major step forward in helping to democratize HIV self-testing and reach the more than 7,000+ people who are still undiagnosed in Canada,” says Rourke in a release. “This gives people the freedom to test when and where it works best for them, right in their own community.”
Distribution and Global Availability
St Michael’s Hospital (Unity Health Toronto) serves as the exclusive distributor of the OraQuick HIV Self-Test in Canada. The hospital will ensure national access to the test, supporting timely and equitable access across healthcare and community settings nationwide.
The OraQuick HIV Self-Test has been available for direct-to-consumer purchase in the US since 2012 and is now available in more than 60 countries worldwide. The packaging contains educational material and linkage to care information to help individuals make informed decisions regardless of test results.
OraSure Technologies, based in Bethlehem, Pennsylvania, develops and manufactures rapid diagnostic tests and sample collection devices. The company’s portfolio includes products sold to clinical laboratories, hospitals, physicians’ offices, public health organizations, and direct to consumers globally.
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