A rapid test importer who edited COVID test results during the pandemic is in hot water — having done so while on a $2 billion federal contract.
According to Global News, BTNX, a Toronto-based small rapid test supplier reportedly deleted dozens of samples used in a study they submitted to Health Canada.
In October 2020, BTNX submitted an application to the federal agency with ‘impressive estimates’ on its Chinese COVID-19 antigen test.
However, the publication’s year-long investigation into the supplier’s submissions uncovered deletions to make their tests appear more reliable.
Outside the most severe cases of COVID-19, the device could not accurately detect the virus in users — producing many false-negative results.
New Canadian study reveals 42% false-positive rate for rapid antigen COVID tests https://t.co/mL42sdve5q via @RebelNews_CA @dax_christensen
— Yanky 🇺🇲 (@Yanky_Pollak) January 18, 2022
“The Government of Canada considered many factors when selecting rapid test suppliers,” the ministry wrote in response to questions about the edited study. “BTNX met these criteria to a sufficient degree.”
“All COVID-19 tests […] are supported by scientific evidence demonstrating that they consistently met standards to provide accurate and reliable results,” it added.
BTNX denied the accusations in a request for comment by Global News. “We have at all times operated with integrity and transparency and have manufactured and distributed our COVID-19 rapid tests in accordance with Health Canada and international standards,” wrote its lawyer Richard Dearden.
In a bid to deflect, Dearden said the U.S. health regulator, the Food and Drug Administration, used different guidelines on the types of samples to include in studies. “BTNX did as well,” he added.
However, the FDA did not change the guideline until October 2021. BTNX did not address the discrepancy in their statements.
In 2021 and 2022, the federal government purchased 404 million rapid tests imported from China by BTNX on 15 contracts worth $2 billion, courtesy of then-Health Ministers Patty Hajdu and Jean-Yves Duclos.
The company became Canada’s leading rapid test supplier during the pandemic without explicit expertise in testing for infectious diseases. Previously they sold test kits for illicit drug consumption.
According to the Global News investigation, the rapid tests came from Chinese manufacturer Assure Tech, whose original evaluation of the device differed from BTNX’s edited study.
Leading medical researchers in Canada called the supplier’s deletions “unethical” and potentially “dangerous.”
“Removal of data is a violation of all research principles,” said Dr. Anna Banerji, an infectious disease specialist at the University of Toronto’s Dalla Lana School of Public Health. A positive result can be trusted, but not a negative one, she added.
Bàrbara Baro, a biomedical researcher at the Barcelona Institute for Global Health, studied the test in early 2021 and said the screening tool is not dependable.
“[If] I want to visit my grandma who is 90 in a nursing care home,” she said, “I wouldn’t choose this.”
Three companies – LifeLabs, Dynacare and Switch Health – were awarded federal contracts to manage COVID related testing and screening for a total of $631 million.https://t.co/1WCVwED1Gd
— Rebel News Canada (@RebelNews_CA) February 15, 2022
At the time, many governments around the world evaluated rapid COVID tests but only some posted the results to best inform consumers.
When Global News asked Health Canada if it would investigate the BTNX application, a spokesperson said there are “no plans to reassess the licensure of this medical device” despite also stating the BTNX device is among the “less-sensitive tests” following evaluations of its own.
BTNX offered slightly higher estimates of the kit’s reliability than Assure Tech did in its separate application, reported Global News. Still, the supplier claims its tests are “a reliable testing tool.”
Dearden warned of possible legal action against the publication if it published their investigation, claiming it would cause “damage” to a Canadian company considered a world leader in rapid testing.
