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

Just Posted

The buoys are back in town

Watershed Wanderings column by Lake Windermere Ambassadors

Invermere council okay with ‘reverse grad march’ idea

Nothing finalized and complications aplenty, but Invermere council agrees to grad march idea

101-year-old man targets 101 block fundraising walk for food bank

A centenarian in Invermere has embarked on a new adventure to raise money for the food bank.

Wings Over the Rockies encourages nature viewing during pandemic

Three local photographers and Wings supporters offer nature viewing tips.

Hospital chief of staff provides guidance on COVID-19 and the Columbia Valley as we open up

Chief of staff says: “COVID-19 … is still here and is not going away any time soon.”

Feds looking at ways to reunite families amid COVID-19 border restrictions with U.S.

Some families with members of dual-citizenship have become separated due to the pandemic

Minneapolis cop who knelt on man’s neck charged with murder

Arrest comes after three days of protests, which escalated in violence as demonstrators torched a police precinct

Police watchdog recommends charges against five Mounties in Prince George man’s death

Police used pepper spray on the man, who then had trouble breathing before dying at the scene

B.C. tourism seeks relief as businesses wait for COVID-19 restrictions to ease

Mid-June earliest for more in-province travel to be authorized

VIDEO: Humpback whales put on quite a show

The ‘playful’ pod lingered by a Campbell River tour operator’s boat for quite some time

Introducing the West Coast Traveller: A voyage of the mind

Top armchair travel content for Alaska, Yukon, BC, Alberta, Washington, Oregon and California!

B.C. woman launches First Nations search, rescue and patrol program

Linda Peters envisions trained searchers ready to go at moment’s notice in each B.C. First Nation

Large cruise ships barred from Canadian waters until end of October: Garneau

Last year 140 cruise ships brought more than two million visitors to Canadian ports

Man who bound, murdered Vancouver Island teen still a risk to public: parole board

Kimberly Proctor’s killer is still ‘mismanaging emotions,’ has had ‘temper tantrums’

Most Read