Mobile COVID-19 test kit hits market
Health Canada OKs device that can process nine tests at once, produce results in 45 minutes
Precision Biomonitoring in Guelph has won Health Canada’s approval to sell a mobile COVID-19 test kit and, on Tuesday, became the first company to send out such a kit for use in non-hospital settings.
This week a shipment of the kits, made by U.S. manufacturer Biomeme, went out to mining clients who work in remote Indigenous communities in Northern Ontario and who would typically have to wait up to10 days to get the results of tests for COVID-19 on employees from a lab.
Precision’s mobile kit, which can fit in a laptop-sized bag, can process nine tests at one time and produce results in 45 minutes. It weighs 1.2 kilograms. Tests are conducted by a licensed lab technician in any location, although not near patients.
“To be able to make a contribution to Canadian society is important,” said Mario Thomas, CEO of Precision Biomonitoring. “In February, when we started on this, we felt it was a moral obligation. So we we’re pretty proud of our achievement.
“With this platform, they get results the same day. It’s a big benefit to them.”
One other U.S. developer, Cepheid, has had a rapid-detection platform approved by Health Canada, but the devices are so far being used only in hospitals, including those in Indigenous communities in northern Alberta and at least one in Toronto.
Cepheid’s machines were already in use here to test for infectious diseases such as tuberculosis using specialized cartridges. The company created a new test cartridge for COVID-19 and expects to ramp up shipping of the cartridges from two million a month to six million, but a company spokesperson says that still won’t meet demand.
Precision beat out Spartan Bioscience, the Ottawa-based company that was first to the post with approval from Health Canada in April to distribute a homegrown mobile test kit, the Spartan Cube, which used a coffee-cup-sized DNA analyzer that could process one test at a time.
Ontario ordered 900,000 tests from Spartan and Alberta ordered 250 of the cubes and100,000 tests. The federal government wanted 40,000 tests a month.
But on May1, Health Canada told Spartan that the company’s proprietary swab collected an insufficient sample to conduct Spartan’s test for the virus, although there was no problem with the company’s test cartridge or the analyzer.
Spartan recalled 5,500 tests, including ones shipped to Indigenous communities. In a June 2 statement, the company said they were working around the clock to fix the problem. The company said this week there was no update on the situation.
Meanwhile, Precision says more of its mobile kits will go out to three Indigenous communities in Northern Ontario who are clients of Shared Value Solutions, a Guelph company that does environmental monitoring for the communities.
“It will grow from there in Northern Ontario,” said Thomas.
Currently, Indigenous communities have to wait up from seven to 10 days for lab tests to come back from Thunder Bay or Toronto, which makes it difficult to know if there is an outbreak, let alone control one, said says Dr. Anna Banerji. She’s director of Global and Indigenous Health, Continuing Professional Development, at the University of Toronto, as well as a tropical and infectious disease specialist at the Dalla Lana School of Public Health.
Banerji says the wait for test results also “causes a lot of hardship in Indigenous communities for people that have to be in isolation during that time.”
The Precision test kit, or platform as Thomas calls it, can be used anywhere as long as the test is conducted by a licensed lab technician. Precision has entered into a procurement agreement with the federal government, promising to provide it with the platform, although Thomas says no number has been specified.
Thomas, the former CEO of the Biodiversity Institute of Ontario at the University of Guelph, founded the company in 2016 with a student and two research assistants from the university.
His company originally did work in environmental monitoring and food safety but when the pandemic hit, its founders pivoted to respond. The company recruited seven new employees, effectively doubling the number of staff, who worked 15 to 16 hours a day, seven days a week, for the past four months.
“It was quite an effort by the team. We were determined to make this work,” he said. “And we did.”
The test, which has three steps, can analyze swab samples from the nose or throat. The company does not supply the swabs.
In the first step, a liquid swab sample is put into an “extraction kit” — a tube with a special filter made by Biomeme. The filter captures more of the genetic material in the sample than is typical, making it easier to detect the virus.
A small amount of the captured genetic material is added to another tube that contains chemical reagents that have been freeze-dried to the size of small pebbles, a process that makes them portable and stable for up to two years. Normally, reagents would have to be stored at -20C or they degrade.
When the liquid sample is added to the freeze-dried test, the reagents are activated. The tube is then put into a machine called a thermocycler, which amplifies the genetic material in the sample. The test then looks for two target genes of the virus.
A smartphone app controls the thermocycler, which in a lab setting can weigh around 34 kilograms.
“Part of the coolness factor is that we have reduced it to a hand-held device,” said Thomas of the thermocycler, which is being manufactured by Biomeme.
An algorithm in the app determines whether the test is positive or negative, and results sent to a phone or to the cloud.
The test is “very affordable,” said Thomas, “on par with cost of running test in a central lab” at about $100, he said. Currently each week Biomeme can produce10 thermocyclers and about 5,000 tests, but Thomas said production can be increased as demand grows.