Reasons Health Canada's delay to approve COVID-19 rapid blood tests in Canada

#CanadaHealth; #RapidBloodTestsApproval; #FalsePositive&NegativeResults

Ottawa, Apr 2 (Canadian-Media): An interim order had been signed by Canada's health minister Patty Hajdu two weeks ago to speed up approvals for COVID-19 tests and other medical devices including rapid blood tests, media reports said.

Patty Hajdu. Image credit: Facebook page

Europe, Asia, Australia and the United States have already been using rapid blood tests. 

Besides this,  COVID-19 blood tests are also being developed by academic laboratories.

But so far none of these tests has been approved for use in Canada. More than a dozen companies who could conduct rapid blood tests were concerned why Health Canada is delaying its order for them to proceed with these tests.

With shortages of masks, gloves and testing kits to fight against the coronavirus in Canada the option of rapid blood tests that will tell within 15 minutes if someone has been exposed.

Thousands of rapid test kits are being shipped to hospitals in the U.S. by a company, BTNX Inc., in Markham, Ontario after the U.S. Food and Drug Administration granted expedited approval for their use by health-care professionals only. 

Rapid Blood test. Image credit: BTNX

Mitchell Pittaway, the company's chief financial officer said he would rather be distributing the tests in Canada. 

"The response [from Health Canada] has been a bit longer than what we would have liked to have seen," Pittaway said. "The U.S. has been much quicker."

Although it is not recommended by the company to rely on this test as stand-alone confirmation of an infection,  Pittaway said the test could help reduce the current strain on the laboratory testing system by prioritizing anyone who gets a positive result.

Health Canada said that these tests cannot detect early infections because the body's immune system hasn't had time to produce antibodies against the virus. These tests could only be used  five to seven days after symptoms show up to determine who has been infected.

Health Canada added that due a risk of false positives and false negatives with any test, it  is taking a close look at the rapid blood tests before approving them for use in Canada.

"The department is working with the National Microbiology Laboratory to validate testing and research, along with expert advice, so that we can have confidence in the test results," Health Canada spokesperson Geoffroy Legault-Thivierge said in an email.