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

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.

The Canadian Press

by The Canadian Press

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

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