A medical assistant prepares to take a swab from a patient at a new drive-thru and walk-up coronavirus testing site in Seattle, Saturday, April 25, 2020. THE CANADIAN PRESS/AP-Elaine Thompson

Rapid test for COVID-19 recalled after Health Canada expresses concerns

Spartan Bioscience had promised results in one hour

Health Canada has restricted the use of a recently approved test for COVID-19 to research purposes only, leading to a recall.

In a Sunday (May 3) email, Health Canada said it’s placed conditions of Spartan Biosciences’s authorization to restrict the use of the portable test until “adequate evidence of clinical performance can be provided.”

The test, which promised to provide results in under an hour and eliminated the need to travel to a lab, was approved on April 13. Ontario, Alberta, Quebec and the federal government had already ordered the tests. B.C. was not among the provinces that ordered the Ottawa-based company’s test.

Spartan Bioscience said it as voluntarily recalling its test and performing additional studies.

Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product. The company says Health Canada had no concerns about the accuracy and analytical performance of the product.

On Sunday, chief medical officer Dr. Theresa Tam said this highlighted the importance of quality assurance.

“It was in the real life setting that it didn’t perform well,” Tam said, noting the recall did not affect any patient diagnoses.

READ MORE: Health Canada approves portable COVID-19 test that can provide results within an hour


@katslepian

katya.slepian@bpdigital.ca

Like us on Facebook and follow us on Twitter.

Coronavirus

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Victoria’s 75,000 veggie plants ready to find a home

New gardeners line-up for Get Growing Victoria

Vancouver Island hasn’t seen a new homegrown case of COVID-19 in two weeks

Island’s low and steady transmission rate chalked up to several factors

No one injured in suspicious Victoria boat fire, say investigators

Victoria police and fire personnel called to blaze on waters near Selkirk Trestle May 22

Suspected thief drops backpack of stolen goods and runs

Oak Bay Police use K9 for suspicious male

VIDEO: Saanich police tackle man who refused to move off Trans-Canada Highway

At this point, it is unclear why the man refused to move

Dump truck in Nanaimo snags power lines, snaps hydro pole, crashes

No injuries in incident Monday morning on Old Victoria Road

Ferry sailings scheduled once again at Nanaimo’s Departure Bay terminal

BC Ferries announces that resumption of service June 3 includes four daily round trips

Facing changes together: Your community, your journalists

The COVID-19 pandemic has changed the world in ways that would have… Continue reading

Island Health signs working agreement to turn former Comox hospital into a ‘dementia village’

Island Health has signed a project development agreement with Providence Living to… Continue reading

Kelowna man charged with harming a hamster

The 20-year-old Kelowna man faces several animal cruelty charges

High tech fish transport system set up to ‘whoosh’ salmon past Big Bar landslide

Fish will spend roughly 20 seconds inside the system, moving at roughly 20 metres per second

Trudeau to seek 10 days of paid sick leave for Canadian workers, says talks are ongoing

Paid sick leave is key to keeping COVID-19 spread under control, prime minister says

Snowbirds jets will not be leaving Kamloops, just yet

The Snowbirds have been in Kamloops since May 17 when a plane crashed killing Capt. Jennifer Casey

Most Read