As COVID-19 spreads uncontrollably once again, millions of Canadians are calling for rapid self-tests.
The Omicron variant wave has finished sweeping the suspicions of provincial and Canadian public health agencies about rapid testing, as they are now distributing the few tests they have. Many manufacturers of rapid tests, who sell them all over the world, including Canadian manufacturers, would like to sell them in Canada as well, but cannot do so due to a regulatory approval framework that remains largely unchanged and obstructs.
For comparison, clinical trial results for the mRNA vaccines were announced in mid-November 2020 and following Health Canada approval less than a month later, on December 9, they were in use by mid-December. .
In the case of rapid antigenic tests, while they carry no risk of bodily harm or side effects, and have been available since summer 2020, it is only following the sudden arrival of ‘Omicron in December 2021 that a small number were finally and suddenly approved for self-testing, within two weeks. These tests were initially approved only when administered by a healthcare practitioner and within a few days of symptoms. However, the potential for asymptomatic screening was demonstrated in 2020 following the success of massive screening in Slovakia, as well as at community screening centers in Nova Scotia. Rapid self-tests became available in Europe in spring 2021. In Germany, hundreds of different rapid tests have been approved, 40 of which are for self-testing. Some cost less than a euro.
For the approval of rapid tests, Health Canada adopted the US FDA guidelines of July 2020, without taking into account the Canadian context: a small market fragmented by provincial barriers.
This results in a paradoxical situation with Health Canada presenting itself as Dr Jekyll distributing millions of tests for free to provinces, and on the other, like Mr. Hyde blocking wider access to tests through ill-advised and counterproductive regulatory guidelines that prevent manufacturers from obtaining regulatory approval.
The root cause of the paradox is that rapid tests should be viewed as a screening tool to identify people at high risk of spreading the virus. It has been known since June 2020 that frequent testing with a rapid response time is more important than sensitivity in stopping transmission proactively, because the infectious period only lasts a few days and is particularly high while people are still asymptomatic. These tests must of course be combined with other barrier measures, including the wearing of N95 masks and ventilation.
However, Health Canada still insists on regulating rapid tests as a medical diagnostic tool and uses very strict and inadequate criteria based on comparison with PCR tests. Rather, it would be necessary to assess their capacity to identify infectious patients and to interrupt chains of infection.
The consequences are that only a small number of rapid antigenic tests have been approved, that they are expensive, and the process favors large multinational companies.
So far, only one of the many Canadian companies that produce tests has received approval for professional administration only, and not for self-testing, although their kits are currently distributed to the public and used primarily for self-testing. .
One way to quickly get out of this impasse and allow access to self-tests would be to temporarily and exceptionally authorize tests that have obtained approval from other states, Germany or the United Kingdom, for example. At the same time, the approval guidelines should be thoroughly revised considering the strong need for rapid, inexpensive, and validated tests with a low false positive rate for frequent use, and abandoned the biased comparison with PCR tests, for a true comparison. with other rapid tests already proven.
Finally, to counter the present, and possible future waves, we must also consider the socio-economic impacts, as well as our dependence on foreign manufacturers, as is the case with vaccines, and that we are trying to compensate with billions of dollars. PCR tests and rapid antigen tests have been proven for decades, but new generations of better performing tests have emerged around the world thanks to strategic government initiatives, but not in Canada. We need to develop a strategy guided by scientific progress, innovation, and risk-benefit analysis. Health Canada has a critical role to play, and must adapt to a changing world to provide the opportunity for Canadians and manufacturers who wish to become actively involved in the management of the pandemic, to access rapid antigenic tests. free and over the counter.
* Co-signers: Donald Vinh, infectious disease physician and microbiologist, and associate professor in the Faculty of Medicine and Health Sciences at McGill University; Marie-Pascale Pomey, professor at the School of Public Health at the University of Montreal; Nathalie Grandvaux, professor at the Faculty of Medicine of the University of Montreal and co-director of the Quebec COVID-Pandemic Network; André Veillette, immunologist at the Montreal Clinical Research Institute