TORONTO — An Ottawa company says it’s received approval from Health Canada for its made-in-Canada rapid COVID-19 test.
Spartan Bioscience says it’s now authorized to sell the diagnostic test, which is touted as providing on-site results within an hour.
The company originally unveiled a rapid test for COVID-19 last spring but had to voluntarily recall it and perform additional studies after Health Canada expressed some concerns.
At the time, Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product.
Spartan said the federal agency had no concerns about the accuracy and analytical performance of the product.
The company bills the new Spartan COVID-19 System as “the first truly mobile, rapid PCR test for COVID-19 for the Canadian market.”
“The Spartan system will be able to provide quality results to remote communities, industries and settings with limited lab access, helping relieve the burden on overwhelmed healthcare facilities,” the company said in a news release Saturday.
The Spartan COVID-19 System was developed through clinical evaluation completed in Canada and the U.S., with the University of Ottawa Heart Institute as one of the testing locations.
The company says it’s already started production on the rapid tests.
A spokesperson for Health Canada says the new device meets the agency’s requirements for both safety and effectiveness.
The news comes amid a continuing decline in COVID-19 cases in parts of Canada.
On Saturday, public health officials in Nova Scotia and Newfoundland and Labrador said there were no new confirmed cases of COVID-19.
Public health officials in New Brunswick reported 17 new cases, 10 of which were in the Edmundston region, which was set to go into a lockdown first thing Sunday morning.
Both Quebec and Ontario reported fewer cases Saturday — 1,685 and 2,359 repectively.
However, officials in Ontario expressed concern about a highly contagious U.K. variant of the virus that was detected at a long-term care facility north of Toronto.
Simcoe Muskoka District Health Unit confirmed the variant was behind the outbreak at Roberta Place Retirement Lodge in Barrie, Ont., where 32 residents have died of COVID-19 and dozens of others have tested positive.
Fears of variants that can rapidly spread come as the federal government considers a mandatory quarantine in hotels for travellers returning to Canada.