The dream of at-home rapid testing for COVID-19 in Canada remains just that: a dream.
Health Canada has not received any applications for at-home testing kits, though says it has proactively reached out to manufacturers of such tests and encouraged them to apply.
The FDA granted emergency authorization last week to the first home-based rapid test in the United States, but the company behind it — which was approached by Health Canada — says it has no plans for now to expand into Canada.
Some health experts — as well as opposition politicians — have said what Canada needs is inexpensive and rapid home-based testing, which could lessen the need for long testing lineups and lockdowns.
“I believe that Canada would have the capacity to make home tests if the government pointed its focus that way in regards to funding them,” said Dr. Funmi Okunola, president of Kojala Medical Enterprises Ltd, and a Vancouver-based family physician and COVID-19 medical adviser.
Okunola advocates for the development and use of inexpensive, rapid paper-based COVID-19 tests similar to pregnancy tests, but instead of urine they would use mucus or saliva.
And she says the federal government should be directing more funding at their development, similar to what they’ve done with vaccine research, to scale up production and ultimately bring down costs for individuals.
“Providing there was a comprehensive strategy implemented alongside these home tests and proper education, then if they were used, really in my opinion they would turn the tide of the pandemic, and would buy us time and reduce the spread of COVID-19 while we’re waiting for the vaccines,” she said.
Such tests have been the focus of research both in the United States and in Canada, including work being conducted by Professor Alexandre Brolo in the department of chemistry at the University of Victoria.
“We are working on it,” Brolo said. “It’s a team of very talented researchers. I sometimes look at the news and people are saying ‘We need more tests.’ We are trying. It’s not easy, but I think that we have some encouraging results and I’m hoping that we will be able to contribute to the pandemic at some point.”
In the meantime, a first-of-its kind home-based COVID-19 detection test was given emergency-use authorization from the U.S. Food and Drug Administration last week.
The Lucira All-in-One Test Kit allows individuals to collect their own swab, place it in the test unit (which is a single-use device) and learn the results in under 30 minutes.
According to a company news release, a trial involving more than 100 individuals which compared Lucira results with one of the FDA’s high-sensitivity tests showed positive results agreed 94.1 per cent of the time across all samples, and 98 per cent of the time for negative results.
The test is only authorized to be used by individuals with a prescription, and for now will only be made available in some health-care settings on a limited basis to prescribe to patients for use at home. The company said in a news release that it plans to scale up production so that the kits — which retail about $50 (U.S.) — would be available nationally by spring 2021.
A company spokesperson said they have no plans for now to expand into Canada.
“We have been singularly focused on the FDA, because that’s the foundation for being able to go out there and start manufacturing,” said spokesperson Kevin Knight. “We’re focused on lining up production right now.”
A handful of other firms in the U.S. have been given emergency authorization since the spring to sell home-based collection kits, which allow individuals to take their own nasal or saliva samples but still requires them to send it to a lab for results.
No such home-based collection kits are currently authorized in Canada, and Okunola said it would require already-backlogged labs to ramp up capacity even more to process the results.
At least two American firms with emergency authorization to sell saliva-based home collection devices — Spectrum Solution and P23 Labs — told the Star they also applied to Health Canada months ago, but have yet to get a final decision.
P23 Labs, which received emergency authorization from the FDA in May for its saliva-based home-collection kit, said it was approached by Health Canada in August to submit an application, and the company did so in September.
The company said the process to apply to Health Canada is not as clearly defined as the process for applying to the FDA.
“Nothing from the FDA carries over. The paper trail and documentation required is more difficult. We are stuck as they will not accept the letters of reference from our manufacturers of some of the kit components,” the company said in a statement to the Star.
“P23 Labs is eager to make our at-home COVID19 test kit available and accessible to Canadian customers, as a means to make testing easier and more convenient, and to lessen potential exposure to and spread of the virus.”
Spectrum Solution said it began the process with Health Canada in June. The company said it found the FDA’s and Health Canada’s processes to be “very similar,” though they said unlike Health Canada, the FDA provided a clear estimation of the time the process would take.
Health Canada told the Star it is “working closely” with manufacturers, including P23 Labs and Spectrum Solution, “to determine whether their devices meet safety and effectiveness requirements.”
The regulator said it has received multiple “interim order” applications for several types of saliva collection kits, including some that are home-based. It said it has yet to receive applications for devices that combine saliva collection with COVID-19 testing at home.
(Interim order applications mean that “products that may not fully meet Canadian regulatory requirements but are manufactured to comparable standards may be imported,” according to Health Canada’s website.)
The opposition Conservatives have been adamant that rapid and at-home testing capabilities must be scaled up in Canada to respond to the COVID-19 pandemic, something they’ve accused the federal government of dropping the ball on.
“What we need…is widespread access to frequent, rapid and at-home tests so that we can have targeted isolation measures that more effectively prevent the spread of COVID-19 rather than simply asking Canadians to sit at home for months and months on end without any hope or clarity of how this is going to come to an end,” Conservative health critic Michelle Rempel Garner told reporters this week.
Physician epidemiologist Dr. Nitin Mohan said in an at-home testing scenario, there could be concerns with the test’s sensitivity or whether the individual has properly collected their sample.
He said such concerns could be tempered if a screening tool was included as well. For example, ETIO Public Health Consultants, of which Mohan is partner, recently joined forces with Ontario-based firm Virocule to help launch a testing device that detects loss of smell, a common COVID-19 symptom. The device received Health Canada authorization last month.
He said a screening protocol could include not just the smell testing device, but also whether the person has a fever or other COVID-19 symptoms, prior to taking the actual test for the virus.
“It diminishes the risk of a false negative (test),” said Mohan. “We’re not eliminating it, but we’re dropping that risk down by the time you actually get the test done.”