Health Canada has confirmed that it will review applications for at-home COVID-19 testing devices after recently stating that it would not do so.
The press secretary for the office of the Health Minister said in a statement Tuesday that, despite deciding in June that it would not review applications for such DIY test kits, new information has emerged and the department has changed tack.
“In response to the evolution of the pandemic, Health Canada is now considering applications for home testing devices for screening purposes,” said Cole Davidson. “Health Canada is open to reviewing all testing solutions. This includes approaches that use self-collection and/or at-home test kits, in particular for screening purposes.”
Health Canada regulates the safety and efficacy of all medical devices sold in Canada.
It is not clear at what point the change was made. A Globe and Mail story published Sunday detailed Health Canada’s initial decision to reject applications for the devices, based on concerns that health agencies would not be able to track test results properly and fears that people would misuse the tests.
A notice on Health Canada’s website Tuesday, which was confirmed as up-to-date by a department spokesperson, said the benefits of at-home test kits did not outweigh the risks and that “applications for authorization for these types of medical devices will be rejected without compelling new evidence to the contrary.”
But in a series of tweets posted Monday, Health Minister Patty Hajdu responded to the Globe story by announcing the department had changed course and would be reviewing applications.
“Early diagnosis is critical to slowing and reducing the spread of COVID-19 in Canada. We made emergency changes to allow faster access to COVID-19 tests in Canada, and Health Canada has already authorized a number of testing devices,” Ms. Hajdu said in one tweet.
She also said the official who confirmed that Health Canada would not be reviewing at-home tests “misspoke” and that “Health Canada is open to reviewing all testing solutions as they become available and are proven effective.”
Some Canadian doctors and infectious disease specialists are applauding the change in policy.
Ashleigh Tuite, an epidemiologist at the University of Toronto, said it was a “very positive” move.
However, she pointed out, the messaging from Health Canada still appears to refer to the standard PCR test, which is done with a swab and sent to a lab, as superior to an at-home test. Dr. Tuite said the public should know that both types of tests have their advantages and disadvantages – and at-home testing could help identify more asymptomatic people.
“The advantage of a less sensitive test is that you can do it more frequently,” she said. “You would find symptomatic or asymptomatic people.”
A lab test may be more accurate, she said, but people will generally only get tested once they start showing symptoms.
“With the PCR test, by the time people get that test, patients have already been infectious for a while, and so [that test is] not an excellent tool for interrupting chains of transmission.”
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