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.”
O’Toole’s spokesperson said that Conservatives, “like all Canadians … are concerned about the Trudeau government’s delays in approving new testing methods.”
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.
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.
The 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.