Liberals order millions of unapproved rapid test

Rollout delayed by Health Canada analysis

OTTAWA • The Liberal government announced plans Tuesday to buy 7.9 million rapid COVID tests, even though they have not yet been approved by Health Canada.

With cases rising, testing lines growing and delays piling up for results, the opposition wants to know why more of the rapid tests aren’t already available to Canadians.

But experts caution rapid tests can’t be seen as a silver bullet because many sacrifice accuracy for speedier results.

The 7.9 million tests announced on Tuesday are from Abbott, a U. S. firm that has been selling its ID Now system since the early months of the pandemic. The test combines nasal swabs with a toaster-sized machine that can get a result in 13 minutes. The test is still awaiting Health Canada’s approval and the purchase is conditional on Abbott getting that sign-off.

Procurement Minister Anita Anand said, “These rapid tests will aid in meeting the urgent demand from provinces and territories to test Canadians and reduce wait times for results, which is key to reducing the spread of the virus.”

Conservative health critic Michelle Rempel Garner said Health Canada’s approval process is moving far too slow and leaving Canadians behind.

“We still have no clarity on when these types of tests will be widely available to Canadians. We have no delivery or distribution date, even though the tests are in use in other parts of the world,” she said. “How many schools have had to close because we didn’t have this capability? How many hours were lost as working parents had to stand in line for a test?”

Currently, there are 91 COVID- 19 tests being reviewed by Health Canada according to the agency’s website. None of the tests are home- based, but several could be used in doctor’s office or clinics, without the need for laboratories.

Dr. Supriya Sharma, a senior adviser at Health Canada, said they are moving as quickly as they can, but they have to be sure the tests are accurate before Canadians start using them.

“A test that provides too many false negative results may lead to individuals not isolating as they should, and potentially more people being exposed to the virus. And a test that provides too many false positive results could lead to people needlessly self isolating.”

Sharma said many of the companies applying to Canada for approval haven’t provided important information like user manuals for their devices or details about the nose swabs used as part of the test.

A test Health Canada approved early in the pandemic from an Ottawa company was recalled due to issues with the swab used to collect the sample.

Sharma said tests that are available in other countries are made by companies that haven’t applied in Canada yet. She said while they look to other countries like the U. S., Canada has its own standards and regulations the department has to follow.

Rempel Garner said the government shouldn’t be waiting for companies to come to Canada, but should seek them out.

“At a time when every country in the world is proactively trying to acquire and develop these technologies to protect their people, Justin Trudeau’s cabinet is content to say, ‘ We’re letting them come to us’.”

Health Minister Patty Hajdu said they have added support to the approval process, but they can’t politicize the reviews.

“We have doubled our people. And we’ve sped up our processes to review tests and grant decisions quickly within 40 days of an application.”

The Abbott test the government purchased is a real time polymerise chain reaction (PCR) test, as are many of the others awaiting approval. They are similar to the tests health departments are using across the country, though several promise quicker results by using special analysis machines.

PCR tests use samples from nose swabs and then during the lab process any presence of the virus is boosted, allowing even low level infections to stand out. The tests can find people who have the virus, but may have no or few symptoms.

“It’s amplifying it. That’s the reaction that’s happening and so even if you have small amounts of viral DNA, using the PCR, you’ll find it and detect it,” said Ashleigh Tuite, an infectious disease epidemiologist at the University of Toronto.

But Abbott and other companies have also developed antigen tests, which can also provide fast results and don’t require a laboratory or special equipment.

The antigen tests work like pregnancy tests, requiring a little bit of fluid, usually from a nose swab, which is placed on a reactive substance and delivers results in 15 to 30 minutes with lines appearing on the test indicating a positive or negative result.

Sharma said they are looking at several antigen tests, but it was only on Tuesday that the government posted a minimum standard, which is a test that accurately identifies positive cases at least 80 per cent of the time.

Tuite said it is important to know antigen tests do have limitations, because they don’t amplify the virus the way PCR tests do.

“It’s going to find people when they’re quite infectious and when they’re generating a lot of virus, but it’s not going to find if you were infected two weeks ago, but you’re no longer shedding a lot of virus.”

The Foundation for Innovative New Diagnostics, an NGO that focuses on getting diagnostic tests to developing countries announced a plan Monday to ship up to 120 million rapid COVID

WE HAVE DOUBLED OUR PEOPLE ... SPED UP OUR PROCESSES.

tests. France and Germany announced they would buy millions of the tests as part of the arrangement that will also send the tests to the developing world.

The foundation’s antigen tests are coming from Abbott and SD Biosensor from South Korea. Both firms are still waiting for Health Canada approval.

SD biosensor test stresses its test is for people having symptoms. All of the 115 people the company tested in a trial to prove the efficacy were showing symptoms before the nasal swabs were administered. Abbott’s antigen test is also designed to detect people who are symptomatic and the company warns the test alone does not confirm a diagnosis.

“Negative results don’t preclude SARS- COV-2 infection and they cannot be used as the sole basis for treatment or other management decisions,” reads the information sheet on the product.

Tuite said just because antigen tests are used for people showing symptoms doesn’t mean they can’t be effective.

“If you’re thinking about testing as a way to interrupt transmission, then you don’t need to worry so much about missing the people who are not very infectious,” she said.

She said if the tests were widely available they could potentially be useful in settings like schools or among essential workers.

“It’s not going to be perfect, but the idea is, if you use it widely enough, if you use it frequently enough, it will have an effect at the population level.”