Health Minister Patty Hajdu said today 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 will meet a certain standard.
While the U.S. Food and Drug Administration approved two antigen testing devices months ago — tests that can deliver results in less than 15 minutes — Health Canada is not ready to put its stamp of approval on such tests, Hajdu told reporters at the Liberal cabinet retreat in Ottawa.
She dismissed past U.S. approvals for such devices, saying Canada would rely on its own data.
“We have not had a test submitted to Health Canada for approval yet that satisfies the regulator’s concerns around accuracy,” she said. “We’re not there yet.
“We will not at Health Canada approve a test that, in any way, endangers Canadians’ health and I will say tests that don’t have a degree of accuracy to the satisfaction of the regulators can actually create further harms in communities.”
‘False sense of security’
She said the agency has more research to do to ensure the efficacy of these devices. Some experts have been calling for the swift introduction of rapid tests in Canada, citing recent spikes in the COVID-19 caseload and long waits for conventional tests.
She said she doesn’t want Canadians flocking to pharmacies to get substandard tests that give them a “false sense of security.”
“The hold-up is the technology,” she said, when asked why Health Canada was taking so long to approve the devices.
The FDA, meanwhile, has said approved antigen tests are a safe and reliable way to determine a person’s COVID-19 status.
“Diagnostic testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to help make these critical products available,” the agency said in May.
“Antigen tests will play a critical role in the fight against COVID-19.”
Hajdu announced today that she will convene a panel of experts to help the government review its testing device strategy some seven months into the pandemic.
She said this advisory panel will “help us look at combinations of testing strategies.”
The move comes as health experts like Dr. David Naylor, one of the country’s top doctors and a co-chair of the federal COVID-19 task force, are calling on Health Canada to make testing more accessible at convenient locations and at high-risk sites like schools and some workplaces.
Long lines for testing centres have become commonplace in many parts of the country.
People seeking tests have reported being forced to wait in line for hours at testing sites in Ottawa and Toronto — delays that have made testing a struggle for parents with young children.
While Canadians wait for Health Canada to make more devices readily available, Ontario Premier Doug Ford said today that the province is preparing to deploy some form of testing to hundreds more sites at retailers, such as pharmacies.
This testing would be mostly for asymptomatic people who want to know their COVID status, he said. Testing is already available at pharmacies in some provinces, including Alberta.
After the cabinet retreat, Prime Minister Justin Trudeau touted his government’s $19-billion “safe restart agreement” that will flow federal funds to the provinces and territories to help them grapple with the resurgence of the virus.
He said that some of that money could be used to bolster a province’s testing capacity.
Dr. Dick Menzies, a professor of respiratory epidemiology and an expert on tuberculosis at McGill University, said these testing delays were entirely predictable.
“It’s kind of regrettable because we could have foreseen that this was going to happen in the fall. The second wave was predicted by many when schools re-opened,” he said in an interview with CBC News.
Menzies said the government should make rapid, saliva-based testing more readily available to reduce the strain on the existing testing centres, which he said should be reserved for people experiencing symptoms of COVID-19.
“Saliva sampling turns out to be as good — maybe even better — but certainly as good as nasal pharyngeal swabs for COVID,” Menzies said, citing his own research on testing.
“Clearly, the sampling time is too long for the demand and the personnel. So you’ve got to look for quicker ways to sample and saliva is an obvious solution for these mobile or walk-in centres for people at low risk.”
‘Unpleasant’ and risky
He said the current nasal swab testing process is an “unpleasant” experience that routinely provokes coughing and sneezing fits among those being tested — which is risky for health care practitioners administering the test.
With saliva tests, there’s no “aerosol” or droplets being generated, he said.
“There’s no worker being exposed … it’s much safer to adopt in places like pharmacies,” he said.
The antigen rapid 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 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.
In May, the FDA gave approvals for Quidel Corporation’s Sofia 2 SARS device through an emergency use authorization. Quidel claims its test has a 96.7 per cent sensitivity rate within five days of the onset of patient symptoms.
In July, the FDA issued approvals for Becton Dickinson’s Veritor System for Rapid Detection of SARS-CoV-2. The devices have since been deployed to 11,000 nursing homes across the U.S. to screen residents and staff.
The company said it expects to have the manufacturing capacity for 2 million tests per week by the end of September.