Public Services and Procurement Minister Anita Anand in the present day introduced a plan to purchase roughly 7.9 million speedy point-of-care COVID-19 assessments from U.S.-based Abbott Laboratories.
The buy is supposed to supply different testing choices to Canadians at a time when the nation’s testing equipment is being severely strained, with coronavirus caseloads spiking in some areas.
To date, the overwhelming majority of assessments have been carried out at public well being clinics, with samples then despatched to laboratories for evaluation — a course of that may take days.
Some extent-of-care take a look at might be administered by skilled professionals in different settings. The molecular take a look at Canada is trying to purchase — the ID NOW — can produce outcomes from a nasal swab in as little as 13 minutes.
While Canada has introduced this buy from a well-regarded U.S. agency, the take a look at itself has not but been accepted by Health Canada for distribution.
“As with many of our agreements for equipment, tests and vaccines, we have pursued an advanced purchase agreement to secure Canada’s access to these tests conditional on Health Canada’s regulatory approval,” Anand mentioned.
“These rapid tests will aid in meeting the urgent demands from provinces and territories to test Canadians and reduce wait time for results, which is key to reducing the spread of the virus.”
The U.S. Food and Drug Administration (FDA) first issued an emergency use authorization (EUA) to Abbott for the ID NOW machine in March.
Since then, some researchers have mentioned the machine has led to false positives in a small variety of circumstances. The FDA re-issued a revised EUA on Sept. 18, saying that the take a look at ought to be administered inside the first seven days of the onset of signs.
Anand mentioned that, past the Abbott deal, Canada will proactively buy different speedy assessments in bulk to provide the nation.
With tens of hundreds of assessments being carried out every day, the demand is excessive.
The announcement comes as Health Canada bureaucrats accountable for regulating new testing units are defending the federal government’s response up to now.
Health consultants — together with Dr. David Naylor, the co-chair of the federal authorities’s COVID-19 process pressure — have for weeks been urging regulators to approve speedy testing to take the stress off testing centres.
While different main Western nations similar to the U.S. have approved quite a lot of point-of-care assessments, Health Canada regulators have been sluggish to present the required approvals to deploy these units.
Regulators accepted Cepheid’s Xpert Xpress SARS-CoV-2 machine in late March, a take a look at that can be utilized in each lab and level of care settings.
The subsequent approval for a point-of-care machine — one which might be utilized in a physician’s workplace or a walk-in clinic — solely got here final week.
On Sept. 23, Health Canada accepted to be used in Canada the Hyris bCube — a transportable machine that its Guelph, Ont.-based distributor says can be utilized “wherever people are — anytime, anywhere.”
The regulator hasn’t but accepted any antigen assessments — a distinct type of testing that may be simply deployed to high-risk workplaces and colleges to assist establish constructive COVID-19 circumstances.
In reality, Health Canada solely posted steering for antigen machine producers to its web site in the present day, seven months into the pandemic.
The antigen assessments — which, relying on the machine, use matter collected from a nasal or throat swab — do not require using a lab to generate outcomes.
While a lot quicker, these assessments are thought of by some to be much less correct than the “gold standard” — the polymerase chain response (PCR) testing course of at the moment in use throughout Canada.
Antigen testing units like Quidel Corporation’s Sofia 2 SARS, which acquired emergency authorization from the U.S. FDA in May, can produce leads to lower than 20 minutes. As of Tuesday, Quidel’s machine was listed as “under review” by Health Canada.
Antigen assessments have been utilized in hundreds of U.S. long-term care properties for months.
Speaking to reporters on teleconference about Health Canada’s progress, Dr. Supriya Sharma, senior medical adviser to the division’s deputy minister, mentioned she would not suppose the authorization course of has been sluggish up to now.
She mentioned Canada’s regulatory regime is completely different from what’s in place within the U.S. and the division has been targeted on approving lab-based PCR testing units.
“I don’t think we’re slow. We’ve got staff working flat out,” she mentioned. “There’s no file sitting on anyone’s desk not being looked at.”
Sharma mentioned it is troublesome to state precisely when the Abbott take a look at or an antigen take a look at will likely be accepted to be used in Canada.
“Antigen testing is our number one priority and we are doing everything that we can to review these tests to ensure they are available to Canadians,” she mentioned.
“We have increased the efficiency and we’re streamlining those review processes. We’re committed to getting a company a decision within 40 days,” she mentioned, including that the pre-pandemic course of typically would take months to finish.
She mentioned regulators is not going to be rushed, citing the chance of approving a defective take a look at that tells individuals they’re away from COVID-19 after they’re truly contaminated.
“A test that doesn’t meet this criteria could have devastating consequences for Canadians,” Sharma mentioned.
When requested if the division was reluctant to approve new units due to previous missteps, Sharma conceded Health Canada’s early choice to authorize a tool from Ottawa-based Spartan Bioscience — a take a look at that later proved defective — resulted in some “lessons learned” for regulators. In May, the National Microbiology Lab discovered issues with the take a look at that made it unreliable.
While Canadian regulators haven’t but given the inexperienced gentle, the World Health Organization (WHO) introduced on Monday a plan to ship 120 million COVID-19 antigen assessments to low- and middle-income nations over the subsequent six months to dramatically develop entry to testing in locations the place PCR is not viable on account of restricted laboratory capability.
The WHO touted these assessments as “highly portable, reliable and easy to administer, making testing possible in near-person, decentralized healthcare settings.”
“High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission,” Dr. Tedros Adhanom Ghebreyesus, the director common of the WHO, mentioned in asserting the plan.
“The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”
Asked concerning the WHO plan after a gathering with UN officers, Prime Minister Justin Trudeau informed reporters Canada would rely by itself scientists to find out which units ought to be used right here at house.
WATCH: Trudeau is requested about speedy COVID-19 assessments
“As much as we’d love to see those tests as quickly as possible, we’re not going to tell our scientists how to do their job and do that work. We are, however, ensuring that as soon as those approvals happen, we are ready to deliver these tests across the country,” he mentioned.
Raywat Deonandan, an affiliate professor on the University of Ottawa and an professional in epidemiology, mentioned that whereas antigen assessments may be much less delicate than PCR assessments, they are often helpful for “reassurance” functions.
“If someone needs a negative test to go back to work, we’ll use this,” Deonandan mentioned in an interview.
“We need more creative tools on the table and this is one creative tool — again, with the caveat that it matters entirely how you use it, where you use it and by whom,” he mentioned, including that he believes antigen assessments should not be a major diagnostic software.
While antigen assessments can be much less correct, they’re additionally low-cost to provide and straightforward to manage. That means they can be utilized a number of occasions to make sure a extra correct studying — not not like a house being pregnant take a look at.
“The advantage of these types of tests is that you can do them frequently,” mentioned Ashleigh Tuite, an assistant professor on the University of Toronto and an infectious illness researcher.
“You could do it the day that you were going to visit the person who you cared about and it would basically tell you at that point in time, are you infectious? That’s incredibly powerful information.
“It simply makes frequent sense — use each software you’ve gotten.”