Health Canada Says Rapid Blood Test For COVID-19 Still Under Study

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Health Canada says that a rapid Canadian-made coronavirus blood test shipped to the United States is not ready for use here.

CBC News has learned that tests such as the one performed by Markham, Ontario, the company BTNX are pending in this country, despite the fact that sales of the same test have been authorized in the United States, the United Kingdom and Europe.

The company’s chief financial officer, Mitchell Pittaway, told CBC News in an email that Health Canada has told the company that the rapid blood tests of the type it was looking to sell will remain under study until a “greater national strategy on their use be developed”.

“I will say we were very disappointed with these comments,” said Pittaway, noting that the company has been able to sell “tens of thousands” of tests in the United States through an emergency program that free from normal regulatory processes.

CEO Iqabal Sunderani said, “We have a sister company in the UK that literally sells this by the millions. It would be nice to have a base in your home country. “

While Canada’s medical laboratories are working on a backlog of tests using nasal swabs, blood tests that could hasten diagnosis are left out here.

BTNX, located in Markham, Ontario, ships thousands of its rapid blood tests to hospitals in the United States. (BTNX Inc.)

Unlike traditional swabs that test for the virus, these rapid tests use only a few drops of pinprick blood on the finger to detect the presence of antibodies that fight the virus. No travel to a laboratory required, results are available on site in 15 minutes.

The tests cost around $ 10 each.

Although they cannot detect the virus in its early stages – as nasal swabs can – rapid blood tests are effective in diagnosing people about five to seven days after symptoms appear, once the body has had the possibility of producing antibodies.

The test can also help identify people who are immune to the disease – including people who have had the disease, as well as some people who may have contracted the virus but never got sick.

Dr. Jean Carruthers, a Vancouver ophthalmologist and eye plastic surgeon, wrote a letter to the federal government after learning about the BTNX test. He was co-signed by 90 doctors.

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“Knowing that you are immune and that you can go back to work and can help your fellow Canadians makes perfect sense,” said Carruthers. “I am really disappointed that we have a test done in Canada by Canadians that cannot be used by Canadians. “

Carruthers cited Germany and South Korea as good examples of countries that have systematically used rapid blood tests to identify who can safely return to work in primary care and the service sector, rather than having huge amounts of workers on break. Those who have been eliminated can also help find the contacts of infected people, which is always done when a patient is positive.

Infectious disease expert Dr. Michael Gardam said using this type of test to identify people immune to the disease could help Canada avoid the “hammer” of the strict physical distancing measures currently in place. (Craig Chivers / CBC)

This sentiment was echoed by Dr. Michael Gardam, an infectious disease specialist and chief of staff at the Humber River Hospital in Toronto.

“It would allow us to back off from the hammer, and we could be much more selective in the type of control measures we implement, because we cannot continue to do what we are doing now. ” longer. “

In an email to CBC News, Health Canada said it was following the advice of the World Health Organization, “which currently does not recommend [blood] clinical diagnostic tests. ”

“The department is working with the National Microbiology Laboratory to validate testing and research, as well as expert advice, so that we can have confidence in the results of the tests,” said the email.

At BTNX, Pittaway said he expected a different response soon.

“We have seen the speed at which other health agencies around the world have been able to make these decisions. And we think Canada will hopefully be able to make an informed decision soon enough. “

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