Faulty COVID-19 tests

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A positive COVID-19 test held in two blue-gloved hands.
This thing has all the accuracy of a bad pregnancy test. Matthias_koll_leverkusen via Pixabay

Putting Canadian lives at risk…

If you have ever taken a rapid COVID-19 antigen test in Canada, you may be familiar with the “Rapid Response” brand, which comes in a small green box. You wouldn’t be alone, as the tests were widely distributed in Canada. 

However, in late 2023, a Global News investigation found that the company producing them may have falsified research data on testing accuracy. The test producers received approximately $2 billion in federal contracts from 2021-2022, despite submitting incomplete data on product accuracy to Canadian regulators.  

A year-long investigation of the federal procurement process found that BTNX, the rapid test supplier from Toronto, deleted dozens of samples from a study they submitted to Health Canada. After BTNX deleted the data, the rapid COVID-19 tests appeared more reliable and sensitive than they had been found to be.  

Prior to the COVID-19 pandemic, the company did not possess specific expertise in products for infectious diseases, yet the company rose to become Canada’s primary rapid test supplier. Health Canada and the Public Health Agency of Canada (PHAC) bought 404 million tests from BTNX. 

In October 2020, BTNX sent an application to Health Canada seeking approval to sell rapid tests for COVID-19. The submission included a study that implied the test would detect 94.55 per cent of infections in people who had symptoms for less than 14 days. Yet, two months prior BTNX told health authorities in Peru the tests could detect 80.2 per cent of infections.  

Although this remains alleged and has not been proven in court, the inaccuracy in results poses serious implications. Rapid tests such as the BTNX “Rapid Response” tests were a major part in Canadians pandemic response and helped to determine whether it was safe to leave home, see people or return to work.  

According to an investigation by Global News, the device could detect the virus in the most contagious people. However, results from the regulators’ evaluation program suggest that BTNX’s test was significantly less dependable in all other cases of COVID-19 infections.  

This means that this oversight might have resulted in the test kit producing a larger proportion of false negatives. In this case, that would mean the test came up negative when it should have been positive. In fact, an assistant deputy minister at Health Canada had previously flagged potential issues with a separate BTNX application.  

Despite this, federal employees reviewing BTNX’s submission did not challenge or request further information from the company. BTNX told Global News investigators they did not provide false or inaccurate information to Health Canada.  

Richard Dearden, the lawyer representing BTNX, said the following on the company’s behalf, “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.” 

As emergent strains of COVID-19 continue, Canadians need access to reliable and rapid testing options. COVID-19 subvariant JN.1 is the new dominant strain across the country. According to the PHAC, the subvariant accounts for over half of all cases in the country.  

The government of Saskatchewan continues to offer Rapid Antigen Testing kits to the public free of charge. Tests are available through local distribution centres across the province.  

Some locations in Queen City include 7 of Regina’s public libraries, Sherwood Co-op Food Store on Quance St., Saskatchewan Polytechnic, University of Regina Campus Security and the Newo-Yotina Friendship Centre. A full list of distribution centres is available online at saskatchewan.ca. 

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