Federal Conservatives make use of a COVID-19 test not sanctioned by Health Canada
A serological or antibody test is not typically used to diagnose an active coronavirus infection
The Ontario caucus of the federal Conservative Party made use of a COVID-19 serological test that has not yet been approved by Health Canada, according to Conservative MP Scot Davidson.
Davidson, the Ontario caucus chair, said the caucus used the device "for safety" prior to a recent caucus retreat. COVID-19 cases are rising sharply in parts of the country, including Ontario, and party leader Erin O'Toole, his wife and at least one of his staffers have all tested positive for the virus.
O'Toole's wife, Rebecca, received a positive test result late Monday after developing symptoms over the weekend.
Bloc Québécois Leader Yves-François Blanchet also has tested positive and his entire caucus is now in self-isolation.
A spokesperson for O'Toole said the Ontario caucus invited a Canadian company that is seeking approvals from Health Canada to distribute its serological test to appear at its regional meeting.
Interested MPs were given the chance to take the test after they were shown a presentation by the company promoting the testing device, she said. The spokesperson said the test already has received approvals from the U.S. Food and Drug Administration.
"We had all our MPs tested that came to our Ontario caucus retreat," Davidson told reporters ahead of the Conservative caucus meeting this morning.
"We had an unapproved test that's waiting for approval from Health Canada so we need to see the government take action and speed up the process to approve these tests. We tested 28 MPs in 39 minutes with the results."
Watch: Conservatives use unapproved COVID-19 antibody test:
O'Toole's spokesperson said that Conservatives, "like all Canadians ... are concerned about the Trudeau government's delays in approving new testing methods."
NDP Leader Jagmeet Singh said he found it "completely unbelievable" that the Ontario Tory caucus would agree to meet with the company and subject themselves to a device that has not yet been approved by Health Canada.
"I have to say that the Conservatives have really shot their credibility," Singh told reporters.
"The fact that a company came to lobby them with a testing device and then they used that testing device that had not received clearance from our Canadian approval process, and then are bragging that they used this service or this testing ... that does not sound like a story that you would normally read in Canada," he said.
A serological or antibody test like the one used by the Ontario caucus is not typically used to diagnose an active coronavirus infection.
Antibodies are made by the immune system in response to an infection. Antibodies can take several days or weeks to develop after infection and may stay in the blood for several weeks or more after recovery.
So antibody tests — which use a blood sample from a finger prick — usually are reserved for people looking to learn whether they've been infected by coronavirus at some point in the past.
The FDA warns that these tests can't "diagnose active coronavirus infection at the time of the test, or show that you do not have COVID-19."
Health Canada says it is "not aware of any serological-based test that has been validated for diagnosing COVID-19.
"However, serological tests will play an important role in Canada's overall testing strategy, providing evidence in assessing the true extent of COVID-19 in the general population."
A number of public health experts have urged the federal government to make more tests available in Canada at a time when many people, notably in Ontario and Quebec, are facing hours-long waits for testing through the conventional lab-based process.
Dr. David Naylor, a co-chair of the federal government's COVID-19 task force, has said he'd like to see more rapid testing in Canada that could be administered at pharmacies, schools and other high-risk workplaces to alleviate the growing burden on hospital-run testing centres.
Unlike serological testing, rapid antigen testing has been used in some places like the U.S. to produce diagnostic test results in as little as 15 minutes.
Canada has not yet approved any rapid or antigen testing devices.
Ontario Premier Doug Ford said today that he spoke with Deputy Prime Minister Chrystia Freeland last night about the province's desire to see more rapid tests approved for use in Canada.
He said Freeland is aware of how important these devices are to making testing easier to access at a time when caseloads are spiking.
"Health Canada, it's critical we get this rapid testing," he said. "Nothing is more critical than getting this approved. I just can't stress that enough."
Health Minister Patty Hajdu said last week that Health Canada is not yet satisfied with any of the options it has been reviewing for rapid COVID-19 testing devices — and they will not be deployed across the country until regulators are sure they meet a certain standard.
While the U.S. Food and Drug Administration approved two antigen testing devices months ago, Health Canada is not ready to put its stamp of approval on such tests, Hajdu said.
A spokesperson for Health Canada said authorized COVID-19 test kits can only be used by health care professionals or trained operators, and selling or advertising health products that make false or misleading claims is illegal in Canada.
"The department takes this issue seriously and will use all mechanisms and tools at its disposal to stop these activities," the spokesperson said.
"When non-compliance is confirmed by Health Canada, a number of compliance and enforcement options are available to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications and product seizures. Health Canada may also refer charges under the Food and Drugs Act to the Public Prosecution Service of Canada (PPSC) for potential prosecution."
Rapid antigen tests — which, depending on the device, use matter collected from a nasal or a throat swab — don't require the use of a lab to generate results.
While much faster, these tests are considered by some to be less accurate than the "gold standard" — the polymerase chain reaction (PCR) testing process currently in use across Canada.
If administered properly, PCR tests are highly accurate, identifying positive cases nearly 100 per cent of the time. Antigen tests are also considered highly accurate but they are not as sensitive as molecular PCR tests run through a lab.
With files from the CBC's Janyce McGregor