Why COVID-19 home testing kits aren’t available in Canada

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U.S. health officials approved the first at-home coronavirus testing kit in April for front-line workers in an attempt to expand testing options in most states.

The LabCorp home test first screens people with an online questionnaire, and if authorized by a physician, the company will ship a testing kit to their home.

The kit includes cotton swabs — which are used in the nostrils — a collection tube, an insulated pouch and a box to ship the specimen back to LabCorp.

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FDA commissioner Stephen Hahn said in a statement that the agency authorized the self-swab test based on data showing it is “as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.”

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But coronavirus home testing kits are not currently available north of the border, as they are not approved by Health Canada.

According to the government website, without the guidance of a health-care professional, there is a significant risk that someone may use the home test kit improperly or misinterpret the results.

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“It may also be impossible for health care agencies to collect home test results,” the agency says. “This information is key to important public health decisions involving disease control during a pandemic.”

While home testing kits may be less effective, said Ashleigh Tuite, an infectious disease epidemiologist and professor at the University of Toronto, they can still be useful.

“At this point, we’re understanding that there’s no single solution to how we get out of this pandemic, and every little piece or public health intervention helps,” Tuite said.

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Accuracy of home testing kits

Canadians with suspected current cases of COVID-19 receive either a molecular PCR test — which takes swabs from the nose or throat to send to a lab for testing — or a point-of-care test, which also uses swabs but results are delivered on the spot.

Dr. Zain Chagla, an associate professor of infectious diseases at McMaster University, says home tests use samples from testing sites, like the front of the nose, the mouth or spit.

Samples are generally analyzed in labs the same way professionally administered ones are, but home kits tend to be less effective at detecting the virus.

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“If you compare (home tests) to the PCR test that a lab is using, lab tests are more sensitive,” Tuite explained. “They’re more likely to identify that you’re infected than these home tests.”

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Knowing how to use a home test is also important, Chagla said.

“People need very good and simple-to-understand guidance on doing the test properly so they don’t have a false negative from not sampling correctly, as well as a relatively quick time to get to the lab to be analyzed.”

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In April, Health Canada approved a rapid COVID-19 test by Ottawa-based company Spartan Bioscience, but the test was voluntarily recalled in May after the government expressed concern about its effectiveness.

While testing is undoubtedly helpful and a key part of curbing the spread of COVID-19, PCR tests are not 100 per cent accurate either, Dr. Peter Phillips, a clinical professor of infectious diseases at the University of British Columbia, previously told Global News.

“The (test) sensitivity is only around 60 to 70 per cent,” Phillips said of PCR testing. “The negative test is something that people need to be cautious about because it can give misleading, false sense of security.”

Possible benefits of home tests

Health Canada says applications for home testing devices will be rejected without “compelling new evidence” that shows their effectiveness.

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Tuite said that at the moment, we are not at a point where the technology is ready for widespread rollout in Canada. We need more research to show home tests are effective and safe to use.

But if home testing kits are approved and made easily available for Canadians, they could help ramp up widespread testing, she said. As COVID-19 lockdown measures loosen and schools get ready to reopen in the fall, more testing and a quick turnaround of results is needed, she said.

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Home testing kits might also be helpful for daily use by people in higher-risk groups, Chagla added.

“It would definitely be a great advance for doing surveillance for people without symptoms in health-care workers, congregate care facilities, and isolated/vulnerable communities such as remote Indigenous reserves — in the context of well-designed and thoughtful surveillance strategies in these settings,” Chagla said.

While Chagla says home tests “definitely have a role to play,” they need to be studied carefully in terms of their accuracy and reproducibility — which is Health Canada’s job.

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And even if home tests are introduced, it’s important people still contact their health-care provider to ensure they receive proper advice and followup testing if necessary. Self-isolation is required for anyone with a confirmed or suspected case of COVID-19.

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“Generally, these types of decisions tend to favour the use of (coronavirus) tests only in some sort of medically supervised environment to ensure accuracy of technique as well as confidentiality of the patient… but given the global circumstances, one could consider ways of optimizing this,” Chagla said.

Tuite agrees and says because we are in the midst of the pandemic and want to effectively curb the spread of COVID-19, it’s time to act.

“Now is the time to innovate,” Tuite said. “And this seems like a really promising way forward.”

Future of home testing

Many rapid home testing kits are in the works, including paper-strip tests that work by spitting into a tube of solution and inserting a strip of paper. The strip changes colour within 15 minutes if you test positive for the virus, much like a home pregnancy test.

While paper strips are not yet on the Canadian market, Chagla says they are a very interesting technology and have the potential for wider dissemination. They also could be useful in environments where testing is difficult, like remote communities.

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Of course, rapid tests need to be thoroughly studied just like other home tests, he said, to better understand their accuracy and false-negative risk. But the promise is there.

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“Some people have even discussed implanting this (rapid test) into the masks themselves for health-care workers, and theoretically could be pushed out to communities,” Chagla said.

“Very exciting.”

— With files from the Associated Press

Questions about COVID-19? Here are some things you need to know:

Symptoms can include fever, cough and difficulty breathing — very similar to a cold or flu. Some people can develop a more severe illness. People most at risk of this include older adults and people with severe chronic medical conditions like heart, lung or kidney disease. If you develop symptoms, contact public health authorities.

To prevent the virus from spreading, experts recommend frequent handwashing and coughing into your sleeve. They also recommend minimizing contact with others, staying home as much as possible and maintaining a distance of two metres from other people if you go out. In situations where you can’t keep a safe distance from others, public health officials recommend the use of a non-medical face mask or covering to prevent spreading the respiratory droplets that can carry the virus. In some provinces and municipalities across the country, masks or face coverings are now mandatory in indoor public spaces.

For full COVID-19 coverage from Global News, click here.

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