Health Canada approves first HIV self-testing kits

Study led by MAP Centre at St. Michael’s Hospital paves way for approval

Note: This website was launched on Feb. 18, 2021. The following post is one of a few backdated posts we published with the site launch to share our recent work and activity.

From the St. Michael's Hospital (SMH) Newsroom

"Canadians can now purchase and self-administer a test for HIV in their own home, marking a landmark moment for HIV care and prevention that will allow people to safely discover their status in as little as one minute, in a place that suits them.

Until now, HIV self-testing kits have not been approved for sale across the country, despite the fact that they are available in more than 30 other countries, including the United States, United Kingdom, Germany and France. In 2016, the World Health Organization (WHO) named self-test HIV kits as a key tool in the quest to eradicate the virus.

Health Canada’s licensure of the device on Monday is based on the results of a cross-Canada clinical trial led by Toronto’s MAP Centre for Urban Health Solutions at St. Michael’s Hospital. Knowing a clinical trial was a requirement to have the tests approved in Canada, the researchers sourced funding and conducted the study, with the aim of getting approval from the regulator.

“HIV self-testing has been the missing link to reach the more than 9,000 people in Canada who have HIV and don’t know it,” says Dr. Sean B. Rourke, the study’s principal investigator and a scientist at the MAP Centre for Urban Health Solutions.

“Many of these people do not come forward because of stigma and having more accessible tests and low barrier options is critical for people to get tested so they know their status. Self-testing has been proven to be a cost-efficient and effective prevention measure in the fight against HIV, and it will now move us closer to ending the HIV epidemic in Canada.”

Read the full piece on the SMH website.