Oral HIV self-test approved for sale in Canada

People in Canada have a new, less invasive way to test for HIV at home after Health Canada approved an oral self-test.

U.S.-based OraSure Technologies said Tuesday that its OraQuick HIV self-test has been cleared for sale, making it the first product of its kind approved in Canada.

The test uses saliva swabs to check for the virusAccording to Orasure, it can also be done at home, providing results in as little as 20 minutes.

MAP Center for UrBain Health Solutions at St. Michael’s Hospital in Toronto is its exclusive distributor in Canada.D will be Start taking online orders for tests They will be shipped today and in the coming weeks.

health canada Country’s first domestic test approved For the virus that causes AIDS in 2020, but this required taking a blood sample by pricking your finger.

Dr. Shawn Rourke, A neuropsychologist In St. Michael’s, S.yes the takes oral exam Canadians who may be concerned about having their own blood drawn for testing may seek a less invasive way.

“People want options,” Rourke said. “Both tests work in different types of contexts.”

Canada sees increase in new HIV diagnoses 2023 with 2,434 new cases – Above 1,800 in 2022 – before falling back down 1,826 in 2024. The rate of new diagnoses in 2024 was also significantly 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 simpler and more portable tests can help reach some of the estimated 7,000 Canadians who have HIV but don’t know it.

“These are people who traditionally don’t come into our health care system,” he said. “You need new ways to reach them, and (this test) will meet them where they are.”

high risk communitiesRourke says those at risk for HIV infection — including racialized communities, men who have sex with men and people who inject drugs — may also benefit from the new test.

how it works

OraQuick looks like a popsicle stick with a flat pad on one end that is swabbed along the top and bottom gums – an area that has a high concentration of early HIV antibodies. The swab is then inserted into a plastic carterWait for 20 minutes during the testing process.

very lLike 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 the result. means one line The test is negative, two means it is positive.

Antibody tests like OraQuick can usually detect HIV within 23 to 90 days of exposure, According to the US Food and Drug Administration.

studies have shown thOral HIV tests are usually highly accurate. But Dr. Régine Thomas, director of Montreal’s Clinique Medical L’Actuelle, which cares for HIV-positive patients, says the results of the oral test must be confirmed with a laboratory blood test.

Also, the meaning of an HIV diagnosis today is very different from thatThanks to treatment options decades ago, Thomas says the virus is still highly stigmatized, and getting a positive test is not an easy thing.

“If you find out you’re HIV (positive) and you have stress problems, mental health problems and you don’t have access to rapid care, it can be very dramatic,” he said.

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Test between $15 and $20

OraQuick was approved in the US in 2012, recommended by the World Health Organization in 2016, and is used in 60 countries. According to Rourke, Canada is only conducting the tests now because suppliers wanted proof there was a market and Health Canada wanted assurances it met its standards.

Rourke says each test will cost between $15 to $20, which he hopes will make them fairly accessible.

Still, Thomas says any expense is a barrier to vulnerable communities who need testing most, including young people who struggle with the cost of living and whom he says are not well educated about HIV.

Rourke says he hopes the federal government can also step in with funding that could further reduce costs, or even make them free.

Ottawa invested $8 million in finger prick HIV self-testing in 2022, which was extended to 2024, but RourkeE says it has since received no federal funding to distribute those tests and defray their costs.

Some provincial governments, such as Saskatchewan And Nova ScotiaHas funded its own HIV self-testing programs to keep finger prick kits available.