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

Click to play video 'Questions about reliability of Canada’s newly approved rapid COVID-19 test' Questions about reliability of Canada’s newly approved rapid COVID-19 test
WATCH ABOVE: Questions about reliability of Canada's newly approved rapid COVID-19 test

EDITOR’S NOTE: After this story was published, a Health Canada spokesperson reached out to Global News with different information, saying 2.5 million tests would arrive by the end of December 2020, “with the balance to follow in early 2021.” The story has been updated to reflect that. 

Canadians will have to wait months 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.”

Health Canada says 2.5 million will arrive by the end of December with the rest being delivered in early 2021.

“It usually happens in waves,” she said, cautioning that much hinges on the company’s ability to manufacture the device and its testing supplies.

Story continues below advertisement

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.

Read more: Canada has approved another rapid coronavirus test. Here’s how it could help

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.

“We work with them and we look at their per capita numbers. We look at the epidemiology of the outbreak in each of the provinces and territories [and] we look at the urban and rural sort of split.”
Click to play video 'Coronavirus: Ontario officials say COVID-19 testing demand remains high, reminds province to only get tested ‘if you need one’' Coronavirus: Ontario officials say COVID-19 testing demand remains high, reminds province to only get tested ‘if you need one’
Coronavirus: Ontario officials say COVID-19 testing demand remains high, reminds province to only get tested ‘if you need one’

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.

Story continues below advertisement

“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.

[ Sign up for our Health IQ newsletter for the latest coronavirus updates ]

“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.”

Click to play video 'Nova Scotia testing gargle test for COVID-19' Nova Scotia testing gargle test for COVID-19
Nova Scotia testing gargle test for COVID-19

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.

Story continues below advertisement

READ MORE: Health Canada approves rapid coronavirus test after feds put 7.9M on order

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.

Click to play video 'Coronavirus: Trudeau says Health Canada approved Abbott rapid test amid criticism on delays from opposition' Coronavirus: Trudeau says Health Canada approved Abbott rapid test amid criticism on delays from opposition
Coronavirus: Trudeau says Health Canada approved Abbott rapid test amid criticism on delays from opposition

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

Story continues below advertisement

“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.

READ MORE: Communication, not fines key to 2nd wave coronavirus measure compliance: experts

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.

Story continues below advertisement

“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