Canadian COVID-19 rapid test previously rejected now gets Health Canada approval

An Ottawa company whose rapid test was previously rejected has fixed its product and now has been approved by Health Canada. The company says they are now producing "the first truly mobile, rapid PCR test for COVID-19" for Canada.

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.

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.

The federal government continues to keep borders open for travel, though those entering Canada are being asked to isolate for 14 days.

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