OTTAWA — Rapid COVID-19 testing devices are on the way to remote and Indigenous communities where access and timely results have been hindered by distance and limited resources, officials said Monday after a new test kit was approved over the weekend.
Canada’s chief public health officer, Dr. Theresa Tam, said the hand-held DNA analyzer from Ottawa’s Spartan Bioscience will offer rapid test results for health services in rural and remote areas that otherwise must send their samples to laboratories in larger centres.
Dubbed the Spartan Cube and about the size of a coffee cup, results can be had in less than an hour and do not require the specialized expertise and equipment of a large lab.
Spartan Bioscience said the tests will be rolled out “immediately” but it wasn’t clear how many were ready or where they would first be deployed.
Tam said the number of devices ready for shipment “is constantly being updated.”
“All I can say is we will get everything that this supplier will be able to provide in the coming months,” said Tam.
“The procurement contract itself is: try and secure supply of the devices with 14,000 units per month in the upcoming months, and then see how that progresses in terms of the supply rate. But every day we have to reevaluate the moving parts on this.”
In addition to the federal government, Ontario has ordered more than 900,000 testing kits, while Alberta’s contract is for 100,000 kits. Quebec said Monday it has ordered 200,000.
Manitoba chief public health officer Dr. Brent Roussin said the province has the Cube, but has yet to test its efficacy.
“That work will start tomorrow and once we are convinced that it’s a valid test we will start utilizing that,” Roussin said at a news conference.
Spartan did not immediately respond to a request for more details Monday.
The need for greater testing is widely acknowledged as key to understanding the true scope of COVID-19 infection in Canada, and how best to deploy suppression strategies. Without such control measures, experts warn that health-care systems can be overwhelmed by a surge in cases.
CEO Paul Lem said earlier this month that production was being ramped up in anticipation of Health Canada approval, but he acknowledged that scaling up to full capacity “is going to take some time.”
He expected to begin with weekly shipments in the “thousands,” which would escalate to 10,000.
“Then it ramps up to like 50 (thousand) and then 100,000 per week,” he said.
While remote regions will be prioritized for now, Lem said he could see the day when the test could be deployed at workplaces and individual households.
Lem said he is being inundated with requests for the test to be made available to private businesses, as well as foreign governments.
“Ultimately once devices become widely available enough and tests become affordable … everyone will be testing it,” Lem said of his hopes for the device.
Lem said the test, in which either the nose or throat is swabbed, can be operated by non-laboratory personnel in places such as airports, border crossings, doctors’ offices, pharmacies and clinics.
He said a positive result can be had in about 30 minutes, while a negative result takes a little longer.
But while the Spartan test is rapid, it’s not meant to replace the current testing method, which involves specialized equipment known as PCR machines.
That’s because the PCR machines can process either 96 or 384 samples at a time depending on the size of the machine, whereas each Cube can only do one test in an hour.
Acknowledging the push to ramp up testing quickly, Tam said officials were exploring the possibility of approving other methods that are in use by other countries but she noted there were “significant concerns about the quality of some of those tests.”
Spartan’s competitors include the Chicago-based Abbott, which produces a toaster-sized rapid testing kit that promises a positive result in just five minutes, and a negative result in 13 minutes. The Abbott kit uses a different chemistry called isothermal amplification.
Then there’s the Sunnyvale, Calif.-based molecular diagnostics company Cepheid, which makes a device that can produce results in about 45 minutes.
The U.S. Food and Drug Administration has given each device emergency authorization for use south of the border but they have not been FDA cleared or approved.
Lem said the U.S. devices are manufactured there, which could make them vulnerable to a possible U.S. export ban, such as the one attempted on 3M’s production of N95 masks.
In contrast, Lem said the Spartan Cube uses test cartridges and proprietary swabs that are manufactured in Ottawa, although it does use raw materials sourced from multiple suppliers, including in the United States and Europe.
Lem said his device could play a key role in providing a good picture of just how pervasive COVID-19 is in Canada.
While much of the work detecting infection has focused on densely populated urban centres, Lem said that doesn’t mean COVID-19 is not spreading in smaller communities where rates appear lower.
“Once you have a true confirmed case, there’s probably 10 times that number out in the community. It’s just the lack of testing is not identifying these people.”
— By Cassandra Szklarski in Toronto, with files from Kelly Geraldine Malone