U.S. FDA approves 2 at-home rapid COVID-19 tests. When will Canada catch up?

Pressure is mounting for the Canadian government to authorize COVID-19 rapid tests to be used at home as more have been approved for use in the United States.

Earlier this week, the U.S. Food And Drug Administration (FDA) authorized two more over-the-counter COVID-19 tests that can be used at home to get rapid results.

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The FDA said Abbott’s BinaxNow and Quidel’s QuickVue tests can now be sold in the country without a prescription.

The tests allow users to collect a sample at home, with a nasal swab that is inserted into a test strip. The results are usually ready within 10 to 20 minutes.

Dr. Michael Mina of Harvard told The Associated Press that the expanded testing options would be critical as new virus variants spread and researchers study how long protection from vaccines lasts.

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“Vaccines are incredibly important but they are not the end-all, be-all to this pandemic,” he told the outlet. “We need other tools in our arsenal and the widespread availability and rapid scale-up of tests for people to use in the privacy of their homes is going to be an extraordinary gain.”

How does Canada measure up?

To date, Health Canada has only authorized the sale and use of COVID-19 tests administered by health professionals or trained operators.

In an email to Global News on Saturday, a spokesperson for Health Canada said the agency “is aware of the approval of the COVID-19 tests” in the United States.

“It is important to recognize that Canada’s context is different from the U.S.,” the email read.


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The agency did not expand on how exactly the context differs.

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To date, 63 tests to identify the novel coronavirus have been approved by the Canadian agency. Of those, 15 point-of-care or ‘rapid tests’ devices have been authorized for use.

Those tests, however, still require a health professional or trained personnel to administer.

However, the agency’s website says it is “open to reviewing all testing solutions.”

“This includes approaches that use self-testing kits, to enable individuals with or without symptoms to assess and monitor their own infection status.”

Health Canada requires rapid tests to meet a minimum standard of 80 per cent sensitivity or accuracy before their application can be approved.

However, the federal government is allowing people who enter into the country at some land border crossings to administer their own test, in an effort to limit the amount of professionals needed.

Those samples are then sent to a lab for processing.

In a series of tweets Sunday morning, Kashif Pirzada, an emergency physician in Toronto, said “rapid tests need to be used ASAP to get workplace outbreaks under control.”

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“Many are sitting unused in warehouses across the country,” he wrote. “You can combine the rapid strips (like Abbott Panbio) with much more accurate molecular tests onsite to recheck positive results (Abbott IDNOW).”

He said this, combined with “better masks, vaccinations, improved sick leave, will go a long way to get the situation under control.”

The total number of COVID-19 infections in Canada topped one million on Saturday, as cases of the new, more transmissible variants continue to climb.

Several provinces, including Ontario and Quebec, have imposed more stringent measures in a bid to stem the spread of the virus, while officials work tirelessly to vaccinate the population.

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Advocates have, for months, been urging Health Canada to approve over-the-counter rapid tests for use in Canada, saying they are key to identifying asymptomatic cases and would help alleviate lab backlog.


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In a previous interview with Global News, Colin Furness, an infection control epidemiologist and assistant professor at the University of Toronto, said while the rapid tests approved by Health Canada are useful, at-home screening tests could be even more so.

He said this type of screening test would be “enormously useful” in helping to alleviate the backlog of tests in Canada’s laboratories and would allow businesses and schools to remain open more safely.

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He said they should be utilized not as a diagnostic test, but rather a “screening tool.”

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“It should be seen a little bit like taking your temperature at home,” he explained, adding that anyone who receives a positive result would then follow up with a lab test to confirm the results.


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According to the Health Canada website, the agency is receiving a “very high volume of requests for authorization.”

It was not immediately clear, though, how many of those applications were for rapid, at-home, or ‘over-the-counter’ COVID-19 tests.

–With files from The Associated Press

© 2021 Global News, a division of Corus Entertainment Inc.

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