Health Canada Approves First HIV Self-Test

Federal regulators have long-awaited approval of Canada’s first HIV self-test. Experts say it’s important for diagnosing people who don’t know they’re infected with the virus.

Health Canada granted a medical device license on Monday for a one-minute finger stab blood test manufactured by bioLytical Laboratories based in Richmond, British Columbia.

Researchers and community organizers welcome the move, but some say that regulatory approval is only the first step towards an accessible HIV self-testing strategy.

Canada follows dozens of other countries that are adopting HIV self-testing technology. This technology has been approved by the World Health Organization as a tool to reduce the number of undetected infections.

Public Health Agency of Canada estimates that as of 2016, more than 63,000 Canadians were living with HIV, and one in seven were unaware of their condition. The agency counted 2,561 new cases in 2018 and reported an increase in HIV diagnosis in Canada in recent years. In contrast, other G7 countries are primarily seeing a declining trend in infections.

Dr. Sean Rourke, who led the clinical trial evaluated by regulators as part of a review of bioLytical self-test kits, said the approval was “missing” to reach about 9,000 people in Canada with undiagnosed HIV. Said it could be. Access life-prolonging treatments and prevent further transmission of the disease.

“It opens some incredible doors,” said Roke, a scientist at the Urban Health Solutions Center at St. Michael’s Hospital in Toronto.

“We have had traditional opportunities for testing for years … but self-testing allows people to test at home or where they live. ”

According to bioLytical, the INTI HIV self-test is more than 99% more accurate than traditional test results. The question was whether people would understand how to use it, Roke said.

He launched a survey of about 700 participants at four sites in Ontario, Quebec, and Manitoba in 2019 to assess whether users can follow the test instructions and interpret the results correctly. We supported in August.

The findings, reviewed for publication, show that more than 92% of participants successfully perform “significant” steps to complete the test, including taking a drop of blood and mixing it with the solution. It suggests that you did.

Michelle Zaharik, Chief Scientific Officer at BioLytical, said the study shows that people of all backgrounds across Canada have access to self-testing. She said the device instructions were adjusted to further reduce the room for user error.

Zaharik said the next step would be to discuss with stakeholders and government officials to determine strategies for bringing the product to market.

According to Zaharik, the diagnostics company is also working with US regulators in the hope of making the device available on both sides of the border.

Although it was not possible to pinpoint the price exactly, Zaharik said bioLytical aims for an “affordable and accessible” self-test for all Canadians.

The COVID-19 crisis raised hurdles to prevent people from being tested, Roke said, and the deployment was not immediately feasible. During the crisis, many clinics were closed, exacerbating concerns about access to medical services, travel and waiting times, and the stigma of high-risk behavior.

According to some 300 front-line providers he surveyed in August and September, the pandemic cut access to clinical HIV testing services by almost half.

He is working with a community organization to launch a telemedicine program in January, distributing 60,000 free self-tests and connecting people with care providers.

However, Roke said Canada needs to establish a national self-testing strategy for the technology to fill the gap in the healthcare system, which leaves many people unable to be tested for HIV.

“When we have the science we have about HIV and treatment, we need a strong voice that it is unacceptable in Canada. We do nothing to make them accessible to everyone. ”

Dr. Nitika Pant Pai, a researcher at McGill University Health Center, says users will pay a premium if there is only one HIV self-test on the shelf if there are any signs of deployment in other countries.

In the United States, over-the-counter oral HIV self-tests can be sold at retail prices as high as US $ 40, Pant Pai said, which is affordable for many marginalized people at high risk of HIV. He said it wouldn’t be.

To remove potential financial barriers, Pant Pai says government officials need to subsidize the cost of self-test kits or approve more devices to make the market more competitive. Stated.

“This is historic at first, but then we look forward to promoting more self-tests and point-of-care tests so that more people can access it,” she said. It was.

Doris Peltier, a publicly disclosed advocate of the HIV-positive Anishinaabe tribe, working with Canada’s Aboriginal AIDS network, has shared some of the stigma that self-tests face when indigenous people are screened for HIV. He said he hopes to reduce it. But she said the strategy only works when combined with reasonable efforts to provide culturally sensitive care.

Even if they knew their condition, systematic discrimination in health care could prevent HIV-infected indigenous peoples from being treated, according to Peltier, so authorities could fall into a crack. We need to build a “safety net” to help people with sex.

Francisco Ivanes Carrasco, a community-based researcher at the University of Toronto, warns that innovation tends to cause unexpected complications.

Effective self-testing needs to be integrated into a wide range of campaigns to educate community groups and the general public about how these devices are used and how they relate to other advances in HIV care.

But as the pandemic puts a strain on public health resources, Ibanez-Carrasco wonders if HIV self-testing will provide the necessary push for public health.

“It’s like other tools like pills, or even when we’re vaccinated against COVID,” he said. “It still needs to be involved in health promotion … as people understand what to do with it.”

This report by The Canadian Press was first published on November 3, 2020.