Canada approves HIV self-test to reduce screening barriers

Federal regulators have approved the first HIV self-test in Canada in a long-awaited move that experts say is critical to diagnosing people who don’t know they have the virus. Health Canada granted a medical device licence on Monday to a one-minute, finger-prick blood test manufactured by Richmond, B.C.-based bioLytical Laboratories.

The move comes after a concerted effort by health-care providers and community organizers to get Canada to catch up to the dozens of other countries that have adopted HIV self-testing technology, which has been endorsed by the

World Health Organization as a tool to reduce the number of undetected infections.

As of 2016, there were more than 63,000 Canadians living with HIV, one in seven of whom were unaware of their condition, according to estimates released by the Public Health Agency of Canada.

Dr. Sean Rourke, who led a clinical trial that regulators assessed as part of their review of bioLytical’s self-test kit, said the approval could be the “missing piece” to reaching the roughly 9,000 people in Canada with undiagnosed HIV, allowing them to access life-extending treatment and preventing further transmission of the disease.

“It opens up some incredible doors,” said Rourke. “We’ve had for a number of years traditional opportunities for testing ... but self-testing allows people to test at home or where they live.”

According to bioLytical, the INSTI HIV Self Test is more than 99 per cent accurate compared to traditional laboratory results.