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

Back in Time

Historical Perspective

Food bank doing well thanks to volunteers and donations

Chair applauds staff for stepping up in time of turmoil

COVID-19 highlights lack of connectivity in First Nations communities

Many don’t have access required to utilize online platforms, says First Nations Technology Council

BC SPCA team helps discover new feline virus after outbreak at Quesnel shelter

Fechavirus is a kind of parvovirus, which makes cats and kittens very sick

Restaurants adjust to loosened restrictions

Gateway Grill in Clearwater is one of the establishments that’s reopened its doors to in-house guests

Minimum wage goes up June 1 in B.C. as businesses face COVID-19 challenges

The minimum wage jumps by 75 cents to $14.60 an hour on Monday

Protesters rally against anti-black, Indigenous racism in Toronto

Police estimated the crowd to be between 3,500 and 4,000 and said there was no violence

Feds earmark $1.5M to support recovery of B.C., Indigenous tourism

B.C. money will be split between Vancouver Island and Indigenous tourism

‘We’re sick of it’: Anger over police killings shatters U.S.

Tens of thousands marched to protest the death of George Floyd

Surrey mayor’s party under fire for ‘sickening’ tweet accusing northern B.C. RCMP of murder

Mayor Doug McCallum says tweet, Facebook post ‘sent out by unauthorized person’

Father’s Day Walk Run for prostate cancer will be virtual event this year throughout B.C.

The annual fundraiser for Prostate Cancer Foundation BC has brought in $2.5 million since 1999

Dr. Bonnie Henry announces official ban on overnight kids’ camps this summer

New ban comes after talking with other provincial health officials across the country, Henry says

Senior man in hospital after unprovoked wolf attack near Prince Rupert

Conservation officers are on site looking for the wolf

VIDEO: NASA astronauts blast off into space on SpaceX rocket

Marks NASA’s first human spaceflight launched from U.S. soil in nearly a decade

Most Read