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Millions of coronavirus rapid tests won’t arrive for months: Health Canada

Canadians will have to wait until 2021 before millions of the Abbott rapid COVID-19 test are available for use, says Health Canada’s chief medical adviser.

In an interview with Global News Thursday, Dr. Supriya Sharma said while details are still being confirmed, the first Abbott ID NOW tests should arrive in Canada in the next “two to three weeks.”

But they will only number in the hundreds of thousands, with up to 2.5 million arriving “into the early part of 2021,” said Sharma. “It usually happens in waves,” she said, cautioning that much hinges on the company’s ability to manufacture the device and its testing supplies.

On Tuesday, the government announced it had purchased up to 7.9 million of the rapid polymerase chain reaction (PCR) tests, and the next day Health Canada announced its approval.

The test works by detecting the novel coronavirus’s DNA and promises to return results in 13 minutes or less.

In terms of who will get those tests when they arrive, Sharma said Health Canada is still in discussions with the provinces and territories and hasn’t yet received their specific requests. The allocation decisions are based on a number of factors.

University of Manitoba virologist Jason Kindrachuk is not surprised by that rollout plan, saying something is better than nothing in dealing with the country’s backlog of cases.

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“You have to, first of all, manufacture all of these, and work on the availability of the companies. You can’t force that if it’s not there,” he said.

“So getting those implemented and then knowing that as we move through the fall that we will have additional supplies coming in, I think is very important for us since we don’t really know what we’re going to face yet … on into 2021.”

But as Canadians wait for the Abbott test, there are questions about whether it’s the right test to purchase.

In May of this year, the U.S. Food and Drug Administration flagged concerns about the accuracy of the Abbott ID NOW test, suggesting that it returned an unacceptably high number of false-negative results.

That warning came just days after a study critical of the Abbott ID NOW test was published in the Journal of Clinical Microbiology.

The Trump administration purchased and this week announced it’s ready to deploy a different test manufactured by Abbott: the BinaxNOW. It’s also a rapid test, but it’s an antigen test, which detects the virus’s surface protein rather than its DNA.

Thursday, Ontario Premier Doug Ford told reporters the antigen test is the one he wants to see Ottawa approve.

“I really do have confidence that they’re going to get this out. And I really look forward to it because it’s a game-changer,” Ford said.

Brookings Institution Fellow Dr. Kavita Patel says south of the border, everyone is talking about the antigen tests rather than the PCR.

While she stresses PCR tests are considered the gold standard, some of the high false-negative rates have proved to be “not acceptable.”

“So as a result, United States policy has shifted towards having wide-scale, low-cost rapid antigen testing,” Patel told Global News from Washington, D.C.

Dr. Sharma said she’s aware of issues with “previous versions” of the Abbott PCR test, but she cannot speak to the American data. She’s confident in Health Canada’s approval based on the device and evidence Health Canada received.

Sharma said the data showed the test’s sensitivity, or ability to detect COVID-19, with a regular nasal swab was 93 per cent, and even higher using the deeper nasal pharyngeal swab.

“The data that we’ve seen really supports that level of sensitivity and specificity with the devices and that’s why they were authorized.”

That American study released back in May found the Abbott test showed “low sensitivity with high false-negative results” when compared to another rapid test, the Cepheid GeneXpert Xpress SARS-CoV-2.

Health Canada has also approved the Cepheid test, but only purchased about one million tests. Some are already in use, including in northern Manitoba.

Global News asked both Health Canada and Public Services and Procurement Canada why they purchased so many fewer tests compared to the Abbott.

“As with virtually all contracts for PPE and other medical supplies, including test kits, the quantities negotiated are based on Canada’s needs as well as what the supplier is able to guarantee delivery of. Given the high demand for tests globally, that’s precisely why we’ve pursued multiple agreements with different suppliers for tests,” said a spokesperson for Procurement Minister Anita Anand.

Dr. Sharma also pointed to manufacturing capacity as an issue.

“The landscape around these medical devices and these tests are very complicated. It’s very complex,” said Sharma, stressing Canadians can have confidence in Health Canada’s approvals process.

–With files from Marc-André Cossette, Global News

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