Health Canada is restricting the use of a made-in-Canada, rapid COVID-19 test created by Spartan Bioscience after the National Microbiology Lab found problems with the test that made it unreliable.
"In light of the clinical results, Health Canada has placed conditions on the company's authorization to restrict the use of the product to research use only until adequate evidence of clinical performance can be provided," the federal agency said in an emailed statement sent to CBC, after the story was first reported by Le Journal de Montreal.
"The Spartan product can continue to be used for research purposes only."
The portable test was called a "game changer" by health officials because it reportedly could deliver on-location results in under 60 minutes. Further upgrades to the test made by the Ottawa-based company promised to reduce that time down to 30 minutes.
According to Spartan, Health Canada's concerns stem from the efficacy of the swabs the testing unit uses — and not with the machine itself.
Issue with swabs
The company was first informed by Health Canada about the concerns on Friday.
"The same report indicated no concerns regarding the accuracy and analytical performance of Spartan's test reagents and portable DNA analyzer device," said a statement published on the company's website.
The company has already shipped out 5,500 tests nationally for validation of provincial and federal governments,
The company said it's voluntarily recalling the product to perform more clinical tests.
"Spartan will be working as quickly as possible to address the concerns and bring its test to market," the company said.
Last month, the federal government ordered 40,000 tests a month from Spartan, according to Dr. Theresa Tam, Canada's chief public health officer.
https://news.google.com/__i/rss/rd/articles/CBMiQ2h0dHBzOi8vd3d3LmNiYy5jYS9uZXdzL2NhbmFkYS9vdHRhd2Evc3BhcnRhbi1yZWNhbGwtdGVzdC0xLjU1NTM5NDfSASBodHRwczovL3d3dy5jYmMuY2EvYW1wLzEuNTU1Mzk0Nw?oc=5
2020-05-03 17:04:00Z
CBMiQ2h0dHBzOi8vd3d3LmNiYy5jYS9uZXdzL2NhbmFkYS9vdHRhd2Evc3BhcnRhbi1yZWNhbGwtdGVzdC0xLjU1NTM5NDfSASBodHRwczovL3d3dy5jYmMuY2EvYW1wLzEuNTU1Mzk0Nw
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