Health Canada Approves COVID Rapid Test Device As A Way To Wait For Canada For Workload Spikes


Health Canada regulators today approved the ID NOW COVID-19 rapid test device for use in this country – a move that could result in millions of additional tests for communities across the country struggling with a increase in coronavirus cases.Point-of-care devices supported by Abbott Laboratories can be administered by trained professionals in places such as pharmacies, walk-in clinics and doctor’s offices without the need for a laboratory to determine if a person is infected. by the virus.

The approval comes just a day after the federal government announced it would purchase some 7.9 million ID tests NOW from the US company for distribution in Canada. Molecular devices can produce COVID results in 15 minutes.

To date, the vast majority of testing has been done in public health clinics, with samples then sent to labs for analysis – a process that can take days.

Public Services and Procurement Minister Anita Anand said on Tuesday the purchase was aimed at helping provinces and territories offer more testing options as some cities face queues of several hours in public health screening centers.

The United States Food and Drug Administration first issued an Emergency Use Authorization (EUA) to Abbott for the ID NOW device in March – only one of 248 such authorizations the United States has issued to test devices since the start of the pandemic.

Some researchers have said that this Abbott device has led to false positives in a small number of cases. The FDA reissued a revised EUA on September 18, saying the test should be administered within the first seven days of onset of symptoms.

Ontario Premier Doug Ford: “Health Canada [has] must go faster, faster, please. We are in crisis. “(Chris Young / The Canadian Press)

Speaking to reporters on Wednesday, Ontario Premier Doug Ford praised Abbott as a group of “amazing people.”

The prime minister also said he was eager to see Health Canada approve another form of test that could be used outside of healthcare settings: antigenic devices which – like the ID NOW device – can produce COVID results. in a few minutes.

The regulator has not yet approved any antigen testing. In fact, Health Canada only posted guidelines for manufacturers of antigenic devices on its website yesterday, seven months after the start of the pandemic.

Ford said he wanted to send antigen tests to high-risk places – such as certain workplaces and schools – to identify positive cases early enough to prevent further spread.

“I think it’s an absolute change for the education system, for long-term care. It is absolutely essential. My frustration is how can regulatory authorities in countries around the world approve this? How can the US regulators approve this, and everyone understands that, and it takes so long to go through Health Canada? Ford said.

“People can find out in 15 minutes. Imagine that. Consider going to a pharmacy, taking the test, waiting outside and coming back in 15 minutes and you have your results. Why it takes so long is just beyond me.

“I’m sorry, I don’t always want to take it out on Health Canada, but they need to act faster, faster, please. We are in crisis.

Ford said he was told Health Canada was reluctant to approve rapid test devices after botched approval of the Spartan Bioscience test product at the start of the pandemic.

The device was found to be defective after being subjected to efficacy tests at the National Microbiology Laboratory. Health Canada had to issue a recall of the device in May after the federal government had already placed an order for 40,000 tests.

Antigen testing – which the device says uses material collected from a nasal or throat swab – does not require the use of a lab to generate results.

Although much faster, these tests are considered by some to be less accurate than the “gold standard” – the polymerase chain reaction (PCR) test process currently used in Canada.

Antigen testing devices like the Sofia 2 SARS from Quidel Corporation, which received emergency clearance from the US FDA in May, can produce results in under 20 minutes.

As of Tuesday, Quidel’s device was still listed as “under review” by Health Canada.

Antigen testing has been used in thousands of long-term care homes across the United States for months.


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