Health Canada approves portable COVID-19 test kit

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 devices began rolling out Monday to Public Health Ontario and Ottawa's National Microbiology Lab in Winnipeg, because the Ontario and federal governments were the first clients.

Additional deals will be filled in the order they were signed, said CEO Paul Lem, who did not disclose how many devices were slated for this week's shipment beyond "thousands."

Tam said the number of devices ready for shipment "is constantly being updated," but said the procurement contact is for 14,000 per month in the upcoming months.

"All I can say is we will get everything that this supplier will be able to provide in the coming months," said Tam.

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.

Meanwhile, Nova Scotia's chief medical officer of health Robert Strang said Nova Scotia would take an "urgent look" at the new testing device.

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.

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.

Lem said expected weekly shipments would gradually escalate to 100,000 per week — the capacity of Spartan's Ottawa facility.

In the meantime, he is looking to set up at least one additional manufacturing facility that would push capacity to "hundreds of thousands of tests per week in the summertime."

"Initially, the first phase is we're going to supply the federal and provincial governments, as much as they need. And then the second phase will be Canadian corporations. And then the third phase, if we get there, will be to export," said Lem.

"There's overwhelming demand. We literally have Canadian corporations contacting us everyday, wanting our tests so that they can get their people back to work."

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 face massive domestic demand and 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."

This report by The Canadian Press was first published April 13, 2020.

— with files from Kelly Geraldine Malone in Winnipeg and Keith Doucette in Halifax