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

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 police arrested federal offender Travis Moore April 13, who was wanted for breaching the conditions of his statutory release. (Courtesy of VicPD)
Victoria police arrest federal offender following foot chase

Travis Moore, 28, was wanted for breaching the conditions of his statutory release

A grey whale off the coast of Vancouver Island is being monitored by Canadian and U.S. researchers, as it has developed lesions after being tagged last year. To try and prevent systemic infection from developing, the team administered antibiotics to the whale on March 31 and April 1. (Photo from the NOAA Fisheries website)
Tagged grey whale off Vancouver Island given treatment after developing lesions

Canadian and U.S. whale experts administered antibiotics to the animal on March 31, April 1

Sooke’s Whiffin Spit in a blaze of glory. (Pete Knight photo)
Whiffin Spit in a blaze of glory. Transition Sooke is calling on the municipality to slow its growth. The group came up with a growth scenario proposal for the Official Community Plan (OCP) which looks different to than the survey scenarios that emerged from the district. (Pete Knight photo)
Transition Sooke calls for slower growth rate

Group submits alternate growth scenario for Official Community Plan review

The Farm Fresh website makes it easy to connect with local farmers. (Courtesy Farm Fresh)
Island Farm Fresh Guide lets residents explore local product

Guide appears in this week’s edition of Black Press Media newspapers from Duncan to Victoria

A person receives a COVID-19 vaccine at a vaccination clinic run by Vancouver Coastal Health, in Richmond, B.C., Saturday, April 10, 2021. THE CANADIAN PRESS
B.C. sees 873 more COVID-19 cases Tuesday, decline continues

Hospitalizations up to 377, two more deaths for 1,515 total

Organ donation form from BC Transplant. (BC Transplant)
POLL: Have you registered as an organ donor?

They number 1.5 million strong and growing. But their numbers still fall… Continue reading

Anyone with information on any of these individuals is asked to call 1-800-222-TIPS (8477) or visit the website victoriacrimestoppers.ca for more information.
Greater Victoria Crime Stoppers wanted list for the week of April 6

Greater Victoria Crime Stoppers is seeking the public’s help in locating the… Continue reading

The music video for “Green and Blue” featured a Willington Care Centre in Burnaby as well as some of the volunteers and employees. (Screenshot/Todd Richard)
‘Green and Blue’: B.C. country musician releases tribute song for front-line workers

Richard’s new single has been viewed more than 3,000 times on his YouTube channel

An unidentified B.C. man said, in a human rights complaint, that he was refused a contract job after refusing to wear a mask when asked to by an on-site manager. (Unsplash)
Religious B.C. man lodges human rights complaint after fired for refusing to wear a mask

Worker’s claim that ‘to cover up our face infringes on our God-given ability to breathe’ dismissed by B.C. Human Rights Tribunal

This 2013 Dodge Ram 1500 was stolen from Black Creek Motors at approximately 2 a.m. Sunday, April 11. Photos via blackcreekmotors.com
VIDEO: B.C. car dealer posts clip of thieves towing a truck right off his lot

Video shows one white truck towing another off Vancouver Island lot

FILE – People hold signs during a memorial march to remember victims of overdose deaths in Vancouver on Saturday, August 15, 2020. THE CANADIAN PRESS/Darryl Dyck
B.C. to request federal exemption for simple drug possession

Announcement comes on 5-year anniversary of B.C.’s first public health emergency

(AP Photo/Matthias Schrader, FIle)
Rare blood clots ‘may be linked’ to AstraZeneca vaccines: Health Canada

One case of the adverse effect has been reported in Canada

Restaurant patrons enjoy the weather on a patio in Vancouver, B.C., Monday, April 5, 2021. The province has restricted indoor dining at all restaurants in B.C. due to a spike in COVID-19 numbers. THE CANADIAN PRESS/Jonathan Hayward
B.C.’s COVID-19 indoor dining, drinking ban extending into May

Restaurant association says patio rules to be clarified

Most Read