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

Campbell River Board of Education approves $72-million budget

Trustees pleased budget aligns with board’s new strategic plan

NIC leads province in transition to online biology labs

North Island College (NIC) biology faculty are among the first in the… Continue reading

Like father, like son: second generation hockey player joins Campbell River Storm

Wyatt Murray’s father, Ben Murray, played for the team in late 90s

BC Transit rate change, embarking rules shift into action June 1

Campbell River transit system getting a new day pass

Bride thankful ailing stepdad was able to walk her down the aisle

Ceremony held amidst pandemic in order to fulfill bride’s wish to have stepdad give her away

Facing changes together: Your community, your journalists

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

Mirror business directory and map

If you’d like to be added to the list, shoot us an email

COVID-19: B.C. landlords can’t evict if they decline rent assistance

Emergency order ‘incentive’ for federal program, Carole James says

Duncan’s Queen Margaret’s School pioneers thermal imaging in school reopening

Private school is first in B.C. to use new tech post-COVID-19

Investigators probe death of CN employee at Surrey rail yard

Transportation Safety Board is investigating an ‘occurrence that took place during switching operations’

Trans Mountain starts B.C. leg of pipeline twinning project

Mostly finished in Alberta, Burnaby terminal expanding

NDP getting COVID-19 wage subsidy ‘indirectly,’ B.C. Liberal leader says

Andrew Wilkinson says he’s heard no concerns from public

Most Read