Health Canada approves rapid COVID testing device as Canada braces for caseload spikes

Health Canada regulators today approved the ID NOW rapid COVID-19 testing device for use in this country a move that could result in millions more tests for communitiesgrappling with a surge in coronavirus cases.

The Abbott Laboratories-backed point-of-care devicescan be administered by trained professionals at places like pharmacies, walk-in clinicsand doctors'officeswithout the need for a laboratory to determine if someone is infected with the virus.

The approval comes only a day after the federal government announced that it would buy some 7.9 million ID NOW tests from the U.S.-based firm for distribution in Canada.

A nasal or throat specimen is collected from a patient on a swab and plugged into the ID NOW's analyzer, which can detect the presence of the virus. The moleculardevices can produce COVID results in 15 minutes.

To date, the vast majority of tests have been done at public healthclinics, with samples then sent tolaboratories for analysis a process that can take days.

Public Services and Procurement Minister Anita Anand said Tuesday that the purchase was designed to help the provinces and territories offer more testing options as some cities face hours-long lines atpublic health testing centres.

Speaking in question period today, Prime Minister Justin Trudeau said the government is expecting to receive the first batch of these Abbotttests "in the coming weeks."

A spokesperson for Abbott could not offer a more precise timeline for the delivery of thesetests but said the company isproducing more than two milliona month to meet currentglobal demand.

Abbotthasalreadyshipped more than 11 million ID NOW tests toall 50 U.S. states, Washington D.C. and the U.S. territories.

"We're pleased to bring this same point-of-care test to Canada to help slow the spread of COVID-19 in the coming weeks ... helping detect thousands of positive cases in minutes rather than hours or days," spokesperson Kimberly LaFleur said in a statement to CBC News.

Trudeau said the government has earmarked more money for Health Canada to expedite the approvals process for "new technologies" like these diagnostic devices.

Health experts and the opposition Conservatives have said Health Canada'sregulatory process has been too slow to this point. Other Western nations have hadsuch tests for months.

WATCH: Conservatives call on Trudeau to approve more rapid tests

Conservatives call on Health Canada to approve rapid COVID tests

4 years ago

Duration 2:34

Conservative MP Michelle Rempel Garner questioned Prime Minister Justin Trudeau about the testing approvals. Trudeau confirmed that Health Canada has approved the Abbott Labs rapid test.

Trudeau said his government put "science first" to protect Canadians from faulty devices. He saidregulators were not pressured to approve the device after the multi-million dollar order for Abbott's test.

The United States Food and Drug Administration first issued an emergency use authorization (EUA) to Abbott for the ID NOW device at the end of March just one of248 such authorizations theU.S. has issued for testing devices since the onset of the pandemic. Only three point-of-care tests have been authorized for use in Canada.

Some researchershave said thisAbbott device has led to false positives in a small number of cases. The FDAre-issued a revised EUAon Sept. 18, saying that the test should be administeredwithin the first seven days of the onset of symptoms.

Speaking to reporters Wednesday, Ontario Premier Doug Ford praised Abbott as a group of "incredible folks."

The premier also said he'seager to see Health Canada approve another form of testing that could be used outside of health care settings: antigen deviceswhich like the ID NOW device can produce COVID results in minutes.

The regulator hasn't yet approved any antigen tests.In fact, Health Canada only postedguidance for antigen device manufacturersto its website yesterday, seven months into the pandemic.

Ford said he wants to send antigen tests to high-risk places such as some workplaces and schools to identify positive cases early enoughto avoid further spread.

"I think it's an absolute game-changer for the education system, for long-term care. It's absolutely critical. My frustration is, how can regulatory authorities in countries around the world approve this? How can the U.S. regulatory bodies approve this, and everyone's getting it, and it's taking this long to go through Health Canada?" Ford said.

"People can know in 15 minutes. Imagine that. Think about going to a pharmacy, getting the test, waiting outside, and coming back in in 15 minutes and you have your results. Why it's taking so long is just beyond me.

"I'm sorry, I don't want to always pick on Health Canada but they've got to move faster, quicker, please. We're in a crisis."

Ford said he was told Health Canada is reluctant to approve rapid testing devices after the botched approval of the Spartan Biosciencetesting product early in the pandemic.

The devicewas found to be faulty after it was subjected to efficacy testing at the National Microbiology Laboratory. Health Canada had to issue a recall on the device in May after the federal government alreadyhad placed an order for 40,000 tests.

Antigen tests which, depending on the device, use matter collected from a nasal or throat swab don't require the use of a lab to generate results.

While much faster, these tests are considered by some to beless accurate than the "gold standard" the polymerase chain reaction (PCR) testing process currently in use across Canada.

Antigen testing devices like Quidel Corporation's Sofia 2 SARS, which received emergency authorization from the U.S. FDA in May, can produce results in less than 20 minutes.

As of Tuesday, Quidel's device was stilllistedas "under review" by Health Canada.

Antigen tests have been used in thousands of U.S. long-term care homes for months.