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Pressure mounts on Health Canada to approve rapid COVID testing equipment




With a sudden increase in cases, promising more people to be tested, Canadians are facing formations of several hours at COVID-19 testing centers across the country, and some medical experts are urging Health Canada to approve equipment new to give faster results.

Concerned parents and their children faced a four-hour wait at the main Ottawa test facility on Monday. A similar scene greeted those who demanded a rehearsal on Tuesday. At Toronto’s William Osler testing center, residents were held on hold for more than three hours.

Dr. Theresa Tam, Canada’s top public health official, said today that an approval for people seeking tests could be the installation of rapid testing equipment. Seven months after this pandemic, these terms are not available for use in Canada because Health Canada regulators have not yet approved them.

“I fully agree with a number of comments from experts that we need to increase the testing capabilities portfolio in Canada,” Tam told a news conference.

“This is something we have to put a lot of pressure on. The regulator at Health Canada has said he is prepared to work hard to get us tests that are accurate and reliable. I think people are just trying to be careful. “.

As she called for caution, Tam said “now, I think it’s time to really speed up Canadians’ acquisition of this capacity.”

See: Dr. Theresa Tam in the fast COVID-19 tests

Canada’s Chief Public Health Officer Dr Theresa Tam spoke to reporters at Parliament Hill on Tuesday. 1:40

Tam’s comments come after Dr. David Naylor, one of the country’s top doctors and a co-chair of the federal government’s COVID-19 workforce, urged regulators to give Canadians more testing opportunities ahead of a projected increase in COVID-19 cases.

“We really need some quick tests to be done at assembly points, or meeting points, so that you can use some form of saliva testing or fast nucleic acid test, or even antigen testing in schools and workplaces. That would really help things here, “Naylor said in an interview with CBC Power and politicson Monday.

A quick test, or a test that uses antigen technology, can produce results in minutes and can be used in a wide range of settings, such as doctors’ offices, pharmacies, home clinics, and long-term care homes.

Some public health experts have also said that rapid tests should be sent to schools and some workplaces to deliver on-site results in high-risk settings.

Antigen tests which, depending on the device, use substances collected from a nasal swab or throat do not require the use of a laboratory to generate results.

While they are much faster, some consider these tests to be less accurate than the “gold standard” of the polymerase chain reaction (PCR) test process currently in use across Canada.

If administered properly, PCR tests are very accurate, identifying positive cases almost 100 percent of the time. Antigests are also considered very accurate, but they are not as sensitive as molecular PCR tests going through a laboratory.

Two new tests approved in the US

While Health Canada has been reviewing the effectiveness of these antigen tests for months, U.S. agencies followed two such devices in the summer and they are already in widespread use there.

In May, the US Food and Drug Administration (FDA) granted approvals for Quidel Corporation’s SARS Sofia 2 device through an emergency use authorization.

According to the National Institutes of Health, thousands of Quidel analysts have been in the United States since July. Analyzers can deliver electronic results within 15 minutes claims that his test has a 96.7 percent sensitivity rate within five days of the onset of the patient’s symptoms.

People line up to do a field coronavirus test outside the Brewer Park assessment center in Ottawa on September 14th. (Jean Delisle / CBC)

In July, the FDA issued approvals for the Becton Dickinson Verification System for the SARS-CoV-2 Rapid Detection; the equipment has been deployed in as many as 11,000 nursing homes across the US for screen residents and staff. The company said it is expected to have production capacity for 2 million tests per week by the end of September.

The company also announced Monday that it is investigating complaints of a “small number” of false positives in some houses.

In August, six states announced a plan to wholesale millions of tests from Quidel and Becton Dickinson to increase the use of rapid antigen testing to help detect outbreaks more quickly.

“With major shortages and delays in testing … states have come together to win millions of faster tests to help save lives and slow the spread of COVID-19,” said Maryland Gov. Larry Hogan, a Republican. in the notification of the multi- state pact.

Both companies behind these devices and a third, Korean-based SD Biosensor, Inc., have applied for Health Canada approvals.

As of Tuesday, all have been listed as “under review”.

A health care worker conducts a test at a COVID-19 assessment center at Etobicoke General Hospital in Toronto on Tuesday, April 21, 2020. (Nathan Denette / The Canadian Press)

A Health Canada spokesman said the antigen tests “are being given priority for screening … Health Canada continues to review all applications as soon as possible without compromising patient safety.”

“There is a complete regulatory process that must be clearly observed for all these new tests, and the new tools possible in the toolbox. We need to know the right way to use them and in the right context, added Dr. Howard Njoo, vice president of general medicine. “It may be that they do not perform as well as PCR.”

However if these antigests are not as accurate, Naylor said, they can be an essential line of defense and because of their lower cost and faster results, one can take the test several times to remove errors.

When such tests show that someone has COVID-19, he said, that person should be tested again immediately to confirm the result.

“This test will help rule out false positives. If after those two tests you still have a positive, you say, ‘Okay, let’s make a swab or send the swab to the public health lab,'” Naylor said.

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