• Sebastian Leck

FACT CHECK: Is Health Canada refusing to approve rapid saliva-based tests for COVID-19?

MISLEADING. Health Canada told the Globe and Mail in August that they would not consider home tests, but then reversed their position. A number of tests have been submitted to the department for approval, but Patty Hajdu, the federal health minister, has said that no rapid tests have met the government’s standard for accuracy so far.

In an article criticizing the Canadian government’s response to COVID-19, columnist Chris Selley wrote in the National Post on September 21 that Health Canada is refusing to approve rapid, saliva-based tests for COVID-19. “Jurisdictions all over the world — including the one immediately to our south, to which many Canadians so enjoy comparing themselves favourably — are rolling out rapid saliva-based tests en masse while Health Canada refuses even to approve them,” he wrote.

Saliva-based tests would be less invasive and more convenient than nasopharyngeal swabs, which are administered through the nose and are more commonly used to detect COVID-19. There’s also a possibility that Canadians could test themselves at home using saliva-based tests without the help of a medical professional. However, not all saliva-based tests are rapid point-of-care tests, which are defined as tests that can be analyzed immediately at a clinic, doctor’s office, or at home, rather than needing to be sent to a laboratory.

On August 30, the Globe and Mail reported that Health Canada was not considering home tests for COVID-19 because of the risk that patients may not use them properly. However, the department reversed its position a day later, saying they are open to all tests as long as they are accurate.

There are good reasons to be careful about approving a COVID-19 test before a well-designed trial. A Canadian rapid test called the Spartan Cube was billed to take only thirty minutes to provide results, but the company has since recalled the tests due to the risk of false negatives. In the US, the Centers for Disease Control and Prevention approved a flawed test kit that was used across the country for three weeks at the beginning of the crisis, damaging efforts to contain the virus.

Selley is correct to say that Canada has been slower to approve rapid tests than the US. However, the rapid, point-of-care tests that have so far been approved in the US have not been saliva-based. The US Food and Drug Administration (FDA) has approved a fifteen-minute swab test from the health care company Abbott, which plans to ramp up production to 50 million tests a month by October. The US federal government has since announced that it plans to buy 150 million tests from Abbott to expand the country’s testing capacity.

Separately, the FDA has also approved several saliva-based tests, but they need to be sent to a lab to get the results. The most recently approved test, called SalivaDirect developed by Yale Public Health, requires fewer steps in a laboratory—which allows for a higher turnaround of testing—but it is not considered a rapid test because it can’t be analyzed immediately at a clinic or at home.

Other countries have made similar advances in rapid testing. The UK, for example, plans to launch two new rapid tests this fall that provide results after ninety minutes (both can analyze swab samples and one can analyze saliva samples).

No rapid tests have been approved in Canada so far. Companies from around the world have submitted their tests for approval, but Patty Hajdu, the federal health minister, has told reporters that Health Canada has not been satisfied with the accuracy of rapid tests that they’ve seen. (There are public health experts, however, who say there could still be benefits to rapid tests even if they are less accurate.)

There is a saliva-based test available in Canada, but it is not a rapid test. Schools in British Columbia have announced that they will be launching a “swish, gargle and spit” test that is more comfortable than the usual swab test and doesn’t require the help of a health professional. They plan on expanding the test for use by adults, and Christine Elliot, the Ontario health minister, told the Toronto Star that those same tests will be offered at three hospitals in Toronto in a trial to test their accuracy. The wait for test results, though, is still up to forty-eight hours.

Overall, it’s misleading to say that Health Canada is refusing to approve rapid saliva-based tests. During the summer, they were not accepting applications for home tests but they have reversed that policy. Since then, Health Canada has said that the accuracy of rapid tests—saliva-based or not—has been the major barrier preventing their approval and widespread use.