Health Canada Suspends Sales of Winnipeg Company COVID-19 Detection Tests

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A Winnipeg company is accused of illegally selling COVID-19 tests before obtaining approval from Health Canada.

For at least a week in March, any Canadian with a credit card could have purchased an $ 18 test on the Safecare Canada website.

Online advertising claimed that with a drop of blood and a 15-minute wait, a person could know if they had been “recently or previously infected” with the new coronavirus that causes COVID-19.

“At $ 18 for peace of mind, to find out if you are in the clear or not and that you are not sitting in a queue for people to try to get you tested,” said Jeff Lester , one of the owners of the company, in a March 24. interview with CBC.

“I think it’s very good value for money. “

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Lester told CBC News that he believed it was legal to sell the tests because “anyone can buy products.” But he noted that they were awaiting approval from Health Canada.

“We are really holding back until the Canadian government approves us,” he said.

Health Canada says it is illegal to sell unauthorized health products such as these test kits.

SafeCare tests are designed to look for antibodies a person may have produced in response to the new coronavirus – which signals a recent or previous infection. But they cannot be used for diagnosis because they cannot detect the virus.

“There are companies that sell a product that can mislead people. So we want everyone to be convinced that the product we provide [has] been approved [by the] The Canadian government and this should hopefully be finished by the end of [last] week, “Lester told CBC March 24.

Jason Kindrachuk, Associate Professor at the University of Manitoba and Canada Research Chair in Emerging Diseases, reviews the Safecare Canada test obtained by CBC. (Jaison Empson / CBC)

The test is manufactured by Safecare Biotech Industries based in Hangzhou, China. Safecare Canada has just distributed it, according to Lester. The main business of the Winnipeg company is the distribution of test kits for businesses to detect illegal drugs.

The SafeCare test is just one of many rapid blood tests, known as serological tests, that have flooded the international market in recent weeks, following the COVID-19 pandemic – leaving manufacturers and consumers confused as each country prepares to regulate medical devices.

Although regulators in the United States have allowed companies to sell tests to US laboratories and healthcare professionals without approval, Canada has not authorized it, and none are authorized to sell it here.

No serological test approved in Canada

When CBC News interviewed government officials on the website, the company was ordered to remove all advertising suggesting the tests were on sale.

As of Friday, no serological test has been approved by Health Canada. More than a dozen are currently under investigation, but priority is given to tests that can detect the presence of COVID-19, not just antibodies that a person may have produced in response.

Health Canada has stated that anyone who purchased these tests should not use them and call their doctor if they already have or have medical problems.

“The World Health Organization does not currently recommend serological tests for clinical diagnosis and Health Canada is following this advice,” a Health Canada spokesperson wrote in a prepared statement.

“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 test results. “

Jeff Lester, one of the owners of Safecare Canada, said he stopped all sales after being contacted by Health Canada. (Skype)

Lester said that when Health Canada told him to stop selling the tests, the company immediately complied.

“We have a request for approval from Health Canada. We worked closely with them, so when they asked us to suspend our sales channel during their evaluation phase, we agreed, “said Lester.

According to Lester, “less than 2,500” tests were sold at that time.

After Health Canada’s crackdown, Lester said he canceled orders and refunded customers’ money.

“So our sales have been virtually nothing in Canada,” he told CBC News.

Safecare is licensed to sell these tests in the United States for use by healthcare professionals. Lester says that if Canada does not do the same, soon it will have to focus all of the company’s efforts only on the US market.

“We intend to provide testing to markets where demand is lagging, and we thought Canada was one of these markets,” he said in a statement prepared for Thursday.

Jeff Lester, co-owner of Safecare Canada explains how someone would use the test. 1:08

Someone gave the CBC the test because they were wondering if it was legitimate. The test kit consisted of a small cassette, a blood lancet, a dropper to collect blood and another dropper containing reagent – similar to other blood tests fast on the market.

The blood is placed on a marked spot on the cassette and the reagent is added. After waiting 15 minutes, test strips will appear that would indicate to the user if they are positive for antibodies that show that they have already been infected with COVID-19.

Health experts say there is a good reason the government is carefully studying these antibody tests before putting them on the market.

If people do these tests at home, it can give the false impression that they are testing to see if they are infected with the virus – which it is not, explained virologist Jason Kindrachuk.

Virologist says tests are good “secondary option”

“If someone is negative on this test, it means that they have not generated antibodies. This does not necessarily mean that he does not currently have the virus and is currently unable to transmit the virus, ”said Kindrachuk, an associate professor at the University of Manitoba and a Canada Research Chair in Emerging Diseases.

Serological tests cannot detect early infections because the body’s immune system has not had time to produce antibodies to the virus.

But about five to seven days after the onset of symptoms, they could be used to determine who got infected and who didn’t.

Kindrachuk does not dismiss the usefulness of the test and says it could prove beneficial in good hands.

“I think it’s a great secondary option for clinicians or front-line health workers when they’re screened because it’s quick, it’s convenient,” he said.

“It gives us information that we couldn’t necessarily get from a simple PCR [polymerase chain reaction] test. “

An order form now removed from the Safecare Canada website, where people could order the tests for $ 18. (safecarecanada.com)

PCR is the only one that can detect infection in the early stages, using a nasal swab inserted into a patient’s nose. This is what hospitals and other medical facilities currently use across Canada to detect the virus.

He says that once Canada controls the spread of this virus, scientists will want to study the percentage of the population that has developed immunity – and this is where these antibody tests will come into play.

“I think it has value, especially to understand from a population perspective how many people have actually been infected, because it is starting to give us an idea,” he said.

“If we find out that this virus has been circulating in Canada for a long time – and we don’t know at the moment – will that necessarily provide us with information as to whether or not we have something like collective immunity?”


  • Got a tip for CBC Manitoba Team I to investigate? Send an email or call the confidential information line at 204-788-3744.

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