Health Canada OKs Spartan Bioscience’s rapid COVID-19 test

TORONTO — The federal government has approved an Ottawa company’s made-in-Canada rapid COVID-19 test, Health Canada confirmed Saturday as the nation’s top doctor warned the virus’s impact on the health-care system showed no signs of abating.

The test developed by Spartan Bioscience is performed by a health-care professional and provides on-site results within an hour, a spokesperson for the federal agency said.

Spartan bills the test 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 health-care facilities,” the company said in a news release Saturday.

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 reservations.

At the time, Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product.

The new version uses “any nasopharyngeal swab” rather than one of the company’s own design, Health Canada said, and meets the agency’s requirements for both safety and effectiveness.

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 said it has already started production on the rapid tests.

The news comes as Dr. Theresa Tam, Canada’s chief public health officer, warned that COVID-19 continues to put a strain the health-care system even as daily case counts decline in several long-standing hot spots.

“As severe outcomes lag behind increased disease activity, we can expect to see ongoing heavy impacts on our healthcare system and health workforce for weeks to come,” she said in a written statement.