Health Canada is limiting the use of a rapid COVID-19 test to research purposes only after the National Microbiology Laboratory found the device did not perform well with patients.
During a news conference on Sunday, Canada’s Chief Public Health Officer Theresa Tam said Ottawa-based Spartan Bioscience’s portable test kit was approved by Health Canada on April 11 on an interim order as part of a move to accelerate access to new forms of COVID-19 testing.
However, Tam said the device, which is the size of a coffee cup, still had to be validated in clinical – or real-life – settings. Although the test kit performed well in labs, she said it did not perform well when used on patients at clinical sites in three provinces.
“It may be related to the proprietary swab that goes with the system,” she said. “What Health Canada is doing is to amend the authorized intended use for research use only so that more clinical validation can be done once the manufacturer adjusts its system.”
Asked whether the setback would impact Canada’s target of conducting 60,000 COVID-19 tests per day, Tam said that it will not because that target is based on lab tests not point-of-care tests.
“Really, there’s been no use of this test kit in a way that would have impacted patient diagnostic outcomes because you’re doing this in the context of actual clinical trial evaluation,” she said.
Spartan’s test was approved to great fanfare at a time when Canada’s testing capabilities were struggling to catch up with international jurisdictions that were seeing widespread testing contributing to downward trends in new COVID-19 cases.
The test was intended to be used in rural and Indigenous communities that lack high-volume lab testing capabilities. It is automated and can be operated by non-laboratory personnel in a variety of settings. The kits use test cartridges and proprietary swabs and is manufactured in Ottawa.
Anita Anand, minister of public services and procurement, added that the tests are not being recalled by the government. During the ministers’ news conference, she explained that this turn of events is an expected part of the process of ramping up new forms of testing.
“We were not expecting that they would be ready at this moment in any case,” she said, adding the product is not defective. “Spartan will continue to produce and review and revise the technology that it is producing for the rapid test kits and then, as the testing warrants, they will be able to be used across the country.”
In a statement, Spartan said the company was made aware of the concerns around the test’s proprietary swab on May 1, but the the National Microbiology Lab did not have “concerns regarding the accuracy and analytical performance of Spartan’s test reagents and portable DNA analyzer device.” Reagents are the chemicals used in COVID-19 testing.
Spartan is voluntarily recalling the test kits to undertake additional clinical studies on the swab.
The company said it has shipped 5,500 tests nationally for validation to provincial and federal government health agencies.
Ontario purchased nearly 1 million test kits from Spartan prior to Health Canada’s approval and Alberta Health Services have signed a $9.5-million contract for 250 handheld devices, along with 100,000 test kits.
