In an emailed statement to Global News, they specified the Spartan COVID-19 PCR test kit is a “point-of-care test” to be administered by a health-care professional. Health Canada further added the authorization is for a “new device design.”
A PCR test is designed to detect minute amounts of the novel coronavirus that causes COVID-19, usually through a swab up the nose or in the mouth.
“The Spartan COVID-19 System offers the speed and ease of use of a rapid test, while using the technology of lab-based COVID-testing solutions,” the statement reads.
The company said the test will be able to provide “quality results” to remote communities, industries and settings with limited access to laboratories, which will “help relieve the burden on overwhelmed healthcare facilities.”
In an interview with Global News, Spartan Bioscience Co-Founder Jamie Spiegelman, said what the company has created is “basically a decentralized lab in a box that is the size of a coffee cup.”
According to Spiegelman, test results are ready within an hour.
“The utility of this is so broad, it could be used in hospitals, it could be used in offices and corporations to open up the work environment,” he said. “It could be used anywhere, that’s how easy it is to use and I think it really will supplement central lab testing and open up society.”
Health Canada had previously granted the device regulatory approval, however it restricted its use after issues with the swab were detected.
Those issues, Spiegleman said, have been rectified.
According to Spiegelman, the company does have “about a million or two million tests backordered by the federal government.”
“And we’re going to deliver them.”
He said the company has built up a stock of the tests, and are preparing to ship them out next week.
Spiegelman said Spartan is working to ensure the Canadian governments get their tests first.
“Our goal is to make sure we have filled all the orders in Canada before we go to the U.S. and Europe,” he said
According to the release, the company is now “establishing a new domestic supply chain for rapid diagnostics,” adding that it will create more than 250 jobs in Canada.
Global News has reached out to Health Canada for comment.
More to come…
— With files from Global News’ Abigail Bimman, Global News’ Emerald Bensadoun and The Canadian Press