Ottawa to buy nearly eight million rapid COVID-19 tests despite lack of Health Canada approval

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The federal government has signed a deal to buy nearly eight million rapid COVID-19 tests that return results in less than 15 minutes, despite Health Canada having not yet approved the technology.

Public Services and Procurement Minister Anita Anand and Health Minister Patty Hajdu unveiled the agreement with Abbott Rapid Diagnostics ULC on Tuesday against a backdrop of soaring coronavirus case counts that have fuelled calls for more and faster testing.

“Things have escalated quickly,” Chief Public Health Officer Theresa Tam said, “and they can escalate further unless we all work together to slow the spread of the virus.”

Dr. Tam noted that Canada is now testing an average of about 71,000 people a day, the most since the start of the pandemic. But high demand for coronavirus testing is outstripping the capacity of Canadian labs to perform a gold-standard molecular screen known as a PCR test – particularly in Ontario, where the backlog has forced some COVID-19 assessment centres to turn people away.

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The outcry over testing has prompted some, including Ontario Premier Doug Ford, to accuse the regulatory branch of Health Canada of dragging its feet on authorizing more of the rapid-testing technologies that have already been rolled out elsewhere, including in the United States.

On Monday, U.S. President Donald Trump announced a plan to distribute 150 million rapid coronavirus tests, while the World Health Organization unveiled a global partnership to make 120 million rapid tests available to low- and middle-income countries.

David Naylor, a leader of Canada’s COVID-19 Immunity Task Force and former president of the University of Toronto and dean of its medical school, said Health Canada approval of more rapid coronavirus tests is long overdue. "We needed those tests when schools were reopening, and we need them even more now that the cold and flu season is upon us,” he said by e-mail.

The crux of the debate over rapid coronavirus testing is how much accuracy regulators should be willing to sacrifice in exchange for on-the-spot results. Ms. Hajdu and Finance Minister Chrystia Freeland have both said recently that it would be inappropriate for politicians to press Health Canada to approve any tests that don’t meet the regulator’s standards.

Ms. Hajdu also said the department has hired extra staff to expedite reviews of COVID-19 tests.

“I don’t think we’re slow," Supriya Sharma, chief medical adviser at Health Canada, told reporters during a briefing Tuesday. "We’ve got staff working flat out. There’s no file sitting on anyone’s desk not being looked at.”

Dr. Naylor said he suspected there is a “cultural issue” at play. “Canadian physicians and regulators are more cautious than their American counterparts about new medical technologies. That is almost always the best mindset. However, in this unusual instance, it could be slowing us down unduly and doing more harm than good.”

The Abbott test that Ottawa has agreed to purchase is called the ID Now. Like standard tests performed in labs, it is a molecular test that detects viral material, but it does so in between five and 13 minutes on a portable machine the size of a toaster. It still requires a health professional to collect a sample using a throat or nasal swab.

The U.S. Food and Drug Administration granted the ID Now emergency use authorization for coronavirus testing in March. Less than two months later, in May, the FDA issued a rare public alert about the accuracy of the ID Now, saying the agency had received 15 reports of the machine returning false-negative results.

Abbott has countered that the test performs well when used soon after symptoms emerge. The company has also encouraged doctors to order traditional laboratory tests for confirmation when a patient with all the hallmarks of COVID-19 disease tests negative on the ID Now.

The tests that Mr. Trump promised to ship en masse are also made by Abbott, but they are rapid antigen tests, which look for a protein on the surface of COVID-19-causing SARS-CoV-2, rather than the virus’s genetic material.

Health Canada has yet to approve any rapid antigen tests, despite six companies having applied. Health Canada only posted formal guidance for makers of antigen tests on Tuesday, but Dr. Sharma said the department has been in discussions with interested companies for longer than that.

Andrew Morris, an infectious-disease physician at Sinai Health and the University Health Network, both in Toronto, said public-health officials need to settle on a strategy for deploying rapid tests as soon as possible.

He recommended they be used for regular screening in essential congregate settings such as nursing homes and schools, where the frequency of testing could make up for diminished accuracy.

“You shouldn’t be thinking of these tests solely on their performance without considering how you’re going to use them,” Dr. Morris said.

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