COVID-19 rapid blood test research underway in Manitoba, despite lack of Health Canada approval

By | April 17, 2020

Manitoba’s chief public health officer says research is underway to determine if serological tests, also known as rapid blood tests, can actually detect the presence of antibodies that may point to a coronavirus infection.

“We’re not going to be able to really apply any results to an individual or even a population right now. It’s really early on. It’s at the research stage,” said Dr. Brent Roussin on Friday. 

Roussin said he’s not personally involved in the testing, but believes Manitoba labs have obtained testing kits to validate.

“We’re not doing it at a wide scale right now. So really, we’re looking at weeks before we have something in place here.” 

Serological tests cannot be used for diagnosis because they can’t detect the coronavirus that causes COVID-19. They are instead designed to look for antibodies that have been produced in response to the virus — which signals recent or previous infection.

While regulators in the United States have allowed companies to sell tests to American labs and medical professionals without approval, Canada has not. None of the test kits are authorized for sale here. 

BTNX Inc., in Markham, Ont., is already shipping thousands of rapid tests to hospitals in the U.S. (BTNX Inc.)

Several provinces, including Alberta, B.C. and Saskatchewan, have suggested they plan to start using the blood tests.

In an email to the Canadian Press on Thursday, B.C.’s provincial health officer said that a serology test “should be hopefully coming online in the coming week to 10 days.”

Alberta’s medical health officer told The Canadian Press her province’s testing goal is to do 20,000 tests a day by mid-to-late May.

In Manitoba, “serological tests, or antibody testing, is not underway … but we are investigating it as an option,” a provincial spokesperson said in an email to CBC News on Wednesday.

As of Friday, no serological tests had been approved by Health Canada. However, the federal regulator says health-care professionals can request access to COVID-19 medical devices not yet approved for sale in Canada through the medical devices special access program.

More than 30 devices are currently under review, including one distributed by a Winnipeg company.

Winnipeg’s SafeCare Canada is allowed to sell its tests in the United States. In March, owner Jeff Lester told CBC News if Canada doesn’t follow suit soon, he will have to focus all the company’s efforts solely on the U.S. market. 

“It is our intention to deliver tests to the markets where there is a backlog in demand, and it was our belief Canada was one of those markets.” 

Health Canada says priority is being given to tests that can detect the presence of the COVID-19 virus, and not just antibodies a person may have produced in response to it.

Health Canada said anyone who bought rapid blood tests should not use them, and should all their doctor if they already have, or have medical concerns. 

“The Public Health Agency of Canada’s National Microbiology Laboratory and its partners are working on developing a number of serologic tests in addition to evaluating a variety of commercial serologic tests for COVID-19,” a Health Canada spokesperson said in an email to CBC on Friday.

“It is important to note that serologic testing has not been validated as a routine diagnostic approach, and that molecular testing approaches will continue to be the diagnostic standard,” the spokesperson said.

“At this time, it is envisioned that pilot studies and then larger scale studies will be conducted to investigate the immunity within health-care workers and other select populations.”

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