Feds not convinced COVID-19 self-test kits will help
Cheap, rapid COVID-19 tests simple enough to use anywhere — home, school, the office — could help us climb out of the pandemic disaster, says infectious disease specialist Dr. Andrew Morris. Just spit into a tube or swab your nose, wait a few minutes for the stripes to change colour — results available within minutes.
With no vaccines or “fantastic therapies” for COVID, the best we can do is keep infected people out of buildings to prevent them from unknowingly spreading the virus, says Morris.
Which is why he finds it “absurd” that Heath Canada says the risks of home or self-testing kits outweigh the benefits and that it will reject applications for such devices “without compelling new evidence to the contrary.”
The federal health agency worries that, “without the guidance of a health-care professional,” people would use the home test kit improperly or “misinterpret the results” and that it could be impossible to collect test results — information that’s key to “important health decisions involving disease control during an outbreak,” the department said in an emailed statement.
“If it’s done in a haphazard way … you might actually create more problems, confusion than the actual benefits because you might get maybe a higher risk of false negative results,” Dr. Howard Njoo, Canada’s deputy chief public health officer, said Tuesday during a COVID-19 briefing.
Morris wants the government to seriously rethink its position on home testing. They’re not the solution to COVID, but they are part of it, he believes.
Cheap, rapid testing is the backbone of infectious disease management, says Morris, of the Sinai Health System and University Health Network in Toronto. “But if Health Canada says ‘we aren’t even interested in these tests,’ they are neither being open-minded nor strategic in understanding the potential of these tests.
“The current strategy is not to trust the public ... and we need to change that.”
The gold standard of testing today is a workhorse called reverse transcriptase polymerase chain reaction, or RT-PCR, which amplifies SARS-COV-2 from nasal swabs, so that minute amounts of RNA can be detected. Anyone who is sick or showing symptoms of COVID-19, or who thinks he or she may have been exposed, can get PCR testing.
But PCR testing isn’t designed around getting our lives back to normal, Morris says. It’s expensive, testing capacity is seriously limited and it can take days to get results. Vancouver has seen traffic gridlock at testing sites as B.C. battles with a surge. Ottawa has had four-hourlong waits at its testing sites.
“The only way we can get our society back up and running is by having some better situational awareness than what we have,” Morris says.
The FDA recently granted emergency use approval to a saliva-based test developed by researchers at the Yale School of Public Health. It’s being used to test players and staff from the National Basketball Association. But it’s not a rapid test. It still needs to be processed by labs and machines.
Things will change dramatically with lateral flow assay devices, Morris says. These are inexpensive tests that work like pregnancy tests. Some are paper-based tests designed to detect viral proteins, others are designed to detect, like PCR tests, viral RNA, the genetic blueprint of the virus.
Rapid tests aren’t perfect. They aren’t as sensitive as PCR tests. But they don’t need to be perfect, argues Harvard Medical School epidemiologist Michael Mina.
Mina says the tests can detect the virus when a person is most infectious, with high viral loads. “The vast majority of PCR positive tests we currently collect in this country are actually finding people long after they have ceased to be infectious,” Mina told Harvard Magazine. Paper-strip test could cost a few dollars to produce, he says. Millions could take them almost daily. Frequent testing, with fast results, would help break chains of transmission, Mina tweeted this week.
Morris has heard talk the FDA is expected to authorize several lateral flow assay tests in the coming weeks. “And nothing by Health Canada. To me, this is a massive, massive blind spot.”
One key strategy in the COVID battle is getting people to self-assess, to check for symptoms before leaving home. “You don’t need perfect tests to improve what’s going on — you need tests that are going to be substantially better than the performance art otherwise known as temperature checks and asking people every single day the same questions about symptoms, knowing very well that there are going to be people who are largely not going to be forthright in answering those questions honestly.”