Well being Minister Patty Hajdu stated as we speak that Well being Canada isn’t but happy with any of the choices it has been reviewing for fast COVID-19 testing units — and they won’t be deployed throughout the nation till regulators are certain they’ll meet a sure customary.
Whereas the U.S. Meals and Drug Administration authorized two antigen testing units months in the past — exams that may ship leads to lower than quarter-hour — Well being Canada isn’t able to put its stamp of approval on such exams, Hajdu instructed reporters on the Liberal cupboard retreat in Ottawa.
She dismissed previous U.S. approvals for such units, saying Canada would rely by itself information.
“We now have not had a take a look at submitted to Well being Canada for approval but that satisfies the regulator’s issues round accuracy,” she stated. “We’re not there but.
“We won’t at Well being Canada approve a take a look at that, in any means, endangers Canadians’ well being and I’ll say exams that do not have a level of accuracy to the satisfaction of the regulators can really create additional harms in communities.”
‘False sense of safety’
She stated the company has extra analysis to do to make sure the efficacy of those units. Some specialists have been calling for the swift introduction of fast exams in Canada, citing latest spikes within the COVID-19 caseload and lengthy waits for standard exams.
She stated she would not need Canadians flocking to pharmacies to get substandard exams that give them a “false sense of safety.”
“The hold-up is the know-how,” she stated, when requested why Well being Canada was taking so lengthy to approve the units.
The FDA, in the meantime, has stated authorized antigen exams are a secure and dependable technique to decide an individual’s COVID-19 standing.
“Diagnostic testing is without doubt one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to assist make these crucial merchandise out there,” the company stated in Could.
“Antigen exams will play a crucial function within the battle towards COVID-19.”
Hajdu introduced as we speak that she is going to convene a panel of specialists to assist the federal government overview its testing system technique some seven months into the pandemic.
She stated this advisory panel will “assist us take a look at mixtures of testing methods.”
Individuals wait in line at a COVID-19 testing facility in Burnaby, B.C., on Thursday, August 13, 2020. THE CANADIAN PRESS/ (Darryl Dyck/The Canadian Press)
The transfer comes as well being specialists like Dr. David Naylor, one of many nation’s prime docs and a co-chair of the federal COVID-19 job drive, are calling on Well being Canada to make testing extra accessible at handy places and at high-risk websites like colleges and a few workplaces.
Lengthy strains for testing centres have turn out to be commonplace in lots of elements of the nation.
Individuals searching for exams have reported being compelled to attend in line for hours at testing websites in Ottawa and Toronto — delays which have made testing a battle for fogeys with younger youngsters.
Whereas Canadians await Well being Canada to make extra units available, Ontario Premier Doug Ford stated as we speak that the province is making ready to deploy some type of testing to tons of extra websites at retailers, comparable to pharmacies.
This testing can be principally for asymptomatic individuals who wish to know their COVID standing, he stated. Testing is already out there at pharmacies in some provinces, together with Alberta.
After the cupboard retreat, Prime Minister Justin Trudeau touted his authorities’s $19-billion “secure restart settlement” that can circulation federal funds to the provinces and territories to assist them grapple with the resurgence of the virus.
He stated that a few of that cash may very well be used to bolster a province’s testing capability.
Dr. Dick Menzies, a professor of respiratory epidemiology and an knowledgeable on tuberculosis at McGill College, stated these testing delays had been solely predictable.
“It is type of regrettable as a result of we might have foreseen that this was going to occur within the fall. The second wave was predicted by many when colleges re-opened,” he stated in an interview with CBC Information.
Menzies stated the federal government ought to make fast, saliva-based testing extra available to scale back the pressure on the present testing centres, which he stated needs to be reserved for folks experiencing signs of COVID-19.
“Saliva sampling seems to be nearly as good — possibly even higher — however actually nearly as good as nasal pharyngeal swabs for COVID,” Menzies stated, citing his personal analysis on testing.
“Clearly, the sampling time is just too lengthy for the demand and the personnel. So you have to search for faster methods to pattern and saliva is an apparent resolution for these cellular or walk-in centres for folks at low threat.”
‘Disagreeable’ and dangerous
He stated the present nasal swab testing course of is an “disagreeable” expertise that routinely provokes coughing and sneezing suits amongst these being examined — which is dangerous for well being care practitioners administering the take a look at.
With saliva exams, there is no “aerosol” or droplets being generated, he stated.
“There is not any employee being uncovered … it is a lot safer to undertake in locations like pharmacies,” he stated.
The antigen fast exams — which, relying on the system, use matter collected from a nasal or throat swab — do not require using a lab to generate outcomes.
Whereas a lot quicker, these exams are thought-about by some to be much less correct than the “gold customary” — the polymerase chain response (PCR) testing course of presently in use throughout Canada.
If administered correctly, PCR exams are extremely correct, figuring out optimistic instances almost 100 per cent of the time. Antigen exams are additionally thought-about extremely correct however they aren’t as delicate as molecular PCR exams run by way of a lab.
In Could, the FDA gave approvals for Quidel Company’s Sofia 2 SARS system by way of an emergency use authorization. Quidel claims its take a look at has a 96.7 per cent sensitivity charge inside 5 days of the onset of affected person signs.
In July, the FDA issued approvals for Becton Dickinson’s Veritor System for Speedy Detection of SARS-CoV-2. The units have since been deployed to 11,000 nursing houses throughout the U.S. to display screen residents and employees.
The corporate stated it expects to have the manufacturing capability for two million exams per week by the tip of September.