Rapid test for COVID-19 recalled after Health Canada expresses concerns

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This article was published 03/05/2020 (2013 days ago), so information in it may no longer be current.

OTTAWA – An Ottawa biotech company is voluntarily recalling a rapid test for COVID-19 after Health Canada expressed concern about its effectiveness, dealing a setback to expanded testing in the country.

Spartan Bioscience said Sunday that the concerns centre around the proprietary swab used in the test, but that the Health Canada report out Friday did not raise concerns about the accuracy of the test reagents and portable analyzer device.

The company said it would recall the 5,500 test shipped nationally and work on additional clinical studies to assess the sampling method and swab.

“Spartan will be working as quickly as possible to address the concerns and bring its test to market,” the company said in a statement.

Spartan declined an interview request.

Chief public health officer Dr. Theresa Tam said Sunday at a news conference that real-world trials of the test so far haven’t delivered necessary outcomes.

“While the Spartan system, or the device, performed very well in a laboratory setting, and along the specifications the manufacturer had provided, it was in the real-life setting, in the clinical setting, where it didn’t perform well.”

Tam said the recall won’t affect the national testing goal of 60,000 people a day, since that figure is based on systems already in use, but that it could affect the speed of further test increases and especially affect rural communities where local in-clinic tests would be especially useful.

Prime Minister Justin Trudeau said the federal government has moved to accelerate approvals for testing and other potentially life-saving measures, but also needs to be ready to respond quickly to new information.

“That is why we are being as nimble as we possibly can to respond to what’s working, to what perhaps isn’t working as well as we hoped that it would, and we will always need to adjust every step of the way as new information comes in on a daily basis through this pandemic, through this crisis.”

Health Canada says the product is restricted to research use only until adequate evidence of clinical performance can be provided.

The federal government announced it had approved the hand-held DNA analyzer on April 13.

The need for greater testing is widely acknowledged as key to understanding the true scope of COVID-19 infection in Canada, and how best to deploy suppression strategies.

Canada was hoping to send the devices to remote and Indigenous communities where access and timely results have been hindered by distance and limited resources.

This report by The Canadian Press was first published May 3, 2020.