Global News’ investigation into federal pandemic contracts began with a call in summer 2022 to a reporter from an executive working in the rapid test sector. Officials’ choices of suppliers seemed inexplicable, he said. Why didn’t they hire more Canadian manufacturers?
Few people outside the industry knew that almost all of the $5 billion the Canadian federal government spent on rapid tests between 2020 and 2022 went to importers and to foreign pharmaceutical giants.
Rapid tests were in drastic short supply after pandemic lockdowns began. As Canadians in lockdown waited for Health Canada to procure reliable rapid tests and other medical supplies, Prime Minister Justin Trudeau promised in March and April 2020 to pump billions into local companies, which ideally would address the public health and national security risks of depending on other countries for vital PPE. It was also meant to address a weak supply chain, onshoring manufacturing to ensure effective access to test kits.
That was the plan. But it’s not how events played out.
To understand why and how the federal government selected its suppliers during that time, Global News ran standard checks on all 17 suppliers that won contracts for rapid tests, examining credit records, licences to sell medical devices and corporate registry documents.
BTNX stood out. It had received contracts for 404 million tests — half of the government’s total orders — after a media campaign that left some doctors, public officials, journalists and members of the public confused about where BTNX’s products were made. It had even sparked debate in the House of Commons.
Global News delved in further, tracing the company’s supply chains around the world.
These searches showed that BTNX bought some of its rapid tests from Assure Tech, a manufacturer based in Hangzhou, China, that itself sold rapid tests. Global News found clinical studies for both companies’ tests for COVID-19 on websites that sold PPE during the pandemic.
It was not immediately apparent that the two documents were related. Since they appeared to have been completed at the same locations and on the same dates, Global News compared the documents.
The analysis revealed the data within the studies was identical — except that 132 results were missing in BTNX’s version. To examine the data and documents yourself, please click here.
Global News shared the comparison with leading researchers from several fields including Dr. Anna Banerji, an infectious disease specialist at the University of Toronto’s Dalla Lana School of Public Health; Bàrbara Baro, a biomedical researcher at the Barcelona Institute for Global Health; Dr. Larissa Matukas, head of microbiology at Unity Health Toronto, St. Michael’s Hospital; and Anne Snowdon, CEO and chief science officer of the Supply Chain Advancement Network in Health, which is based at the University of Windsor.
They explained that a study should never be edited. Any specimens, or samples, that need to be excluded from calculation — for example, because a technician made a mistake — should be nevertheless appended to or included within the study.
The question that followed was, how well did BTNX’s test detect the virus?
Global News thoroughly reviewed all known studies of Assure Tech’s test, and found more than a dozen of them. Few offered “apples-to-apples” comparisons.
For example, studies conducted in summer and early fall 2020 tended to involve the earliest version of the kit intended for professional use only. It included the most invasive nose and throat swabs, called nasopharyngeal and oropharyngeal swabs, which are considered the most accurate.
By contrast, studies conducted in late 2020 and early 2021 after that date involved different kits intended for professional and home use, or only for home use. These had less invasive swabs that are considered less accurate.
To find comparable studies, it was also important to consider other factors that affect a kit’s reliability: whether patients were symptomatic; vaccination rates; and which variant patients were infected with. Researchers for the German health ministry also suggested that as the pandemic dragged on, manufacturers sometimes updated their devices without notifying regulators.
Some evaluations in which the test sold by BTNX or Assure Tech did not detect the virus reliably include a study led by Bàrbara Baro, a biomedical researcher at the Barcelona Institute for Global Health (click here), or this German study of the test’s ability to detect Omicron. A Scandinavian centre devoted to studying rapid test performance concluded that the kit sold by Nal von Minden, a German distributor of Assure Tech’s product, did not meet the World Health Organization’s minimum standard.
To check out some of the studies in which BTNX’s test did well, read this study by Dalhousie University in early 2022. This version of the kit was not sold in Canada. Assure Tech’s test also scored high in a study in the Czech Republic. (To read, click here.)
With this review completed, Global News asked, what information could or should have been available to Health Canada when regulators were evaluating the kits?
This question narrowed the list to studies by or funded by government health ministries connected with Health Canada’s mandatory foreign risk reporting program in fall 2020 and early winter 2021. The kit studied had to be the same version BTNX submitted to Health Canada.
The British and German studies we have shared in our graphic were conducted in fall 2020 and winter 2021, when Health Canada was evaluating Assure Tech’s and BTNX’s applications. These studies were published in peer-reviewed journals — the gold standard of research, meaning the papers are vetted by leading experts in the field. The assessments respectively contributed to Britain’s and the European Union’s efforts to create a new framework for the regulation of rapid tests.
All suppliers included in these tables — Canada’s BTNX, Britain’s SureScreen Diagnostics, Germany’s Nal von Minden and China’s Assure Tech, represented by the distributor Azure Biotech — have stated that they have the same quality management certifications. Because they sold the same medical device from the same manufacturer and shared the same quality standards, their products’ performance should theoretically be identical, or virtually identical.
Global News again shared these results with Snowden, Matukas, Banerji and Baro, and other researchers. One expert in medical device regulation suggested that the differences in sensitivity between the four brands seen in the expanded version of the table below may reflect early issues with transportation, storage or manufacturing.
Global News then engaged leading figures in infectious diseases, Food and Drugs Act litigation, and international corporate laws to act as guest editors. Their experience, insights and precision helped bring this important public health story to light.
Comments