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

B.C. government invests $7.5 million through Creative BC to help struggling musicians

Bob D’Eith, MLA for Maple Ridge-Mission, led industry consultations on supports during the pandemic

Fort Gallery re-opens part time to public with exhibition of artist Richard Bond’s work

Fraser Prospect continues Fraser River themed project that the gallery began in January

Langley beekeepers on alert for giant honeybee-murdering hornets recently sighted

Aldergrove beekeeper Bryn Jones ‘concerned’ after South Langley giant Asian hornet sighting

McLeod Athletic Park still closed as $5 million upgrades near completion

Park will host National Track and Field Championships and BC High School Championships

Beatniks Bistro donates $4,000 to Langley School District Foundation

Executive director Susan Cairns said $32,500 is spent every week to help feed Langley families

B.C. records four new COVID-19 cases, Abbotsford hospital outbreak cleared

Four senior home outbreaks also declared over, eight still active

Facing changes together: Your community, your journalists

Thanks for helping the Aldergrove Star to continue its mission to provide trusted local news

RCMP, coroner investigate murder-suicide on Salt Spring Island

Two dead, police say there is no risk to the public

About 30% of B.C. students return to schools as in-class teaching restarts amid pandemic

Education minister noted that in-class instruction remains optional

Trudeau avoids questions about anti-racism protesters dispersed for Trump photo-op

Prime minister says racism is an issue Canadians must tackle at home, too

B.C.’s Law Enforcement Torch Run for Special Olympics goes virtual

The annual event partnering RCMP with Special Olympians is dramatically altered by COVID-19

Bateman program encourages people to sketch outside, connect with nature

#MyNatureSketch initiative encourages Canadians to become ‘bright-eyed three year olds’

Be cautious expanding COVID-19 bubble, Dr. Bonnie Henry tells B.C.

Senior homes stay off-limits as schools, businesses reopen

Most Read