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People in Canada have a new, less invasive way to test for HIV at home, following Health Canada’s approval of an oral self-test.
U.S.-based OraSure Technologies said Tuesday its OraQuick HIV self-test has been greenlit for sale, making it the first of its kind approved in Canada.
The test uses a swab of saliva to check for the virus, and can be done at home, giving results in as little as 20 minutes, according to OraSure.
The MAP Centre for Urban Health Solutions at St. Michael’s Hospital in Toronto is its exclusive distributor in Canada, and will begin taking online orders for the tests today and shipping them out in the coming weeks.
Health Canada approved the country’s first at-home test for the virus that causes AIDS in 2020, but that one required drawing a blood sample by pricking one’s finger.
Dr. Sean Rourke, a neuropsychologist at St. Michael’s, says the oral test gives Canadians who might be squeamish about drawing their own blood a less invasive method to test.
(Eduardo Lima/The Canadian Press)
“People want choice,” Rourke said. “Both tests work in different kinds of contexts.”
Canada saw an uptick of new HIV diagnoses in 2023 with 2,434 new cases — up from 1,800 in 2022 — before dropping back down to 1,826 in 2024. The rate of new diagnoses in 2024 was also considerably higher than the national rate in Manitoba and Saskatchewan — which saw 19.5 new diagnoses per 100,000 and 18.6 per 100,000, respectively, compared to 5.7 per 100,000 for the country overall.
Rourke says he hopes these simple and more portable tests might help reach some of the estimated 7,000 Canadians who have HIV but don’t know it.
“These are people that don’t traditionally come into our health-care system,” he said. “You need new ways to reach them, and [this test is] going to meet them where they are.”
Communities at a higher risk for HIV infection — including racialized communities, men who have sex with men and those who inject drugs — could also stand to benefit from the new test, Rourke says.
How it works
OraQuick looks like a popsicle stick with a flat pad on one end that’s swabbed along the top and bottom gums — an area that contains a high concentration of early HIV antibodies. The swab is then inserted into a plastic cartridge for 20 minutes while the test processes.
Much like a pregnancy or rapid COVID-19 test, the swab has a control line to show that the test worked, and a test line to show results. One line means the test is negative, two means it’s positive.
Antibody tests like OraQuick can usually detect HIV within 23 to 90 days after exposure, according to the U.S. Food and Drug Administration.
Studies have shown that oral HIV tests in general are highly accurate. But Dr. Rejean Thomas, director of Montreal’s Clinique médicale l’Actuel, which cares for HIV-positive patients, says oral test results should be confirmed with a labratory blood test.
Plus, while an HIV diagnosis means something very different today than it did decades ago thanks to treatment options, Thomas says the virus is still highly stigmatized, and getting a positive test isn’t an easy thing to go through.
“If you discover that you’re HIV [positive] and you have a stress issue, mental health issue and you don’t have access to care rapidly, it could be very dramatic,” he said.
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Tests between $15 and $20
OraQuick was approved in the U.S. in 2012, recommended by the World Health Organization in 2016, and is used in 60 countries. According to Rourke, Canada is only getting the test now because suppliers needed proof there was a market and Health Canada needed assurance that it reached its standards.
Rourke says the test will cost between $15 to $20 each, which he hopes will make them fairly accessible.
Still, Thomas says any expense is a barrier for vulnerable communities that need testing most, including younger people who are struggling with the cost of living and who he says are not well educated about HIV.
Rourke says he hopes the federal government might also step in with funding that could bring costs down further, or even make them free.
Ottawa invested $8 million in the finger prick HIV self-tests in 2022, which was extended into 2024, but Rourke says there’s been no federal funding to distribute and reduce the cost of those tests since.
Some provincial governments, such as Saskatchewan and Nova Scotia, have funded their own HIV self-testing programs to keep the finger prick kits available.
New federal figures suggest Manitoba had the highest incidence of HIV across Canada last year, and advocates say the province needs to better evaluate and support services and invest in monitoring to close existing gaps, as Manitoba is on track to hit a new record in 2025.
