Sales of Winnipeg company’s COVID-19 detection tests halted by Health Canada

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

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

The online advertisement claimed that with a drop of blood and a 15-minute wait, a person could find out if they were “recently or previously infected” with the novel coronavirus that causes COVID-19.

“At $18 for a peace of mind, to know if you are in the clear or not and not sitting in lines waiting for people to try to get tests to you,” said Jeff Lester, one of the company’s owners, In a March 24 interview with CBC.

“I think that’s a pretty good value.”

Lester told CBC News he thought it was legal to sell the tests because “anybody can buy products.” But he noted they were waiting for Health Canada’s approval.

“We really are holding back until we do get the Canadian government to give us their approval,” he said.

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

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

“There are firms out there that are selling a product that may mislead people. So we want to have everybody confident that the product we supply [has] been approved [by the] Canadian government and that should be hopefully completed by the end of the [last] week,” Lester said to CBC on March 24.

The test is manufactured by Safecare Biotech Industries based in Hangzhou, China. Safecare Canada just distributes it, according to Lester. The Winnipeg company’s primary business is in the distribution of testing kits for businesses to detect illicit drugs.

SafeCare’s test is just one of the 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 moves to regulate the medical devices.

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

No serological tests approved in Canada

When CBC News asked government officials about the website, the company was ordered to remove any ads suggesting the tests were for sale.

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

Health Canada said anyone who bought these tests should not use them, and call their doctor if they already had or have medical concerns.

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

“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.”

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

“We have an application into Health Canada for their approval. We have been working closely with them, so when they asked us to pause our sales channel during their evaluation phase, we agreed,” Lester said.

“Less than 2,500” tests were sold by that point, according to Lester.

Following Health Canada’s crackdown, Lester said he cancelled the orders and refunded customers’ money.

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

Safecare is allowed to sell these tests in the United States for use by medical professionals. Lester says if Canada doesn’t do the same and 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,” he said in a prepared statement sent Thursday.

An individual gave the test to CBC because they were wondering if it was legitimate. The test kit consisted of a small cassette, a lancet to draw blood, a dropper to collect the blood, and another dropper with reagent in it — similar to other rapid blood tests on the market.

The blood is placed on a labelled spot on the cassette and the reagent is added. After waiting 15 minutes, strips will appear that will allegedly tell the user if they test positive for the antibodies that show they were once infected with COVID-19.

Health experts say there is a good reason the government is studying these antibody tests closely before they go to market.

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

Virologist says tests are a good ‘secondary option’

“If somebody comes up negative on this test, it means that they have not generated antibodies. It does not necessarily mean that they don’t currently have the virus and they’re not currently able 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 hasn’t had time to produce antibodies against the virus.

But about five to seven days after symptoms show up, they could be used to determine who has been infected and who has not.

Kindrachuk doesn’t dismiss the usefulness of the test, and says it could prove beneficial in the right hands.

“I think it’s a great secondary option for clinicians, or frontline health-care workers when they’re doing screens because it’s quick, it’s convenient,” he said.

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

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

He says once Canada gets a handle on the spread of this virus, scientists will want to study what percentage of the population may have developed immunity — and that’s where these antibody tests will come into play .

“I think that there’s a value in it, in particular understanding from a population standpoint how many people were truly infected, because it starts to give us an idea,” he said.

“If we find out that this virus has been circulating in Canada for a long period of time — and we don’t know at this point — does that necessarily provide us with some information saying whether or not we have something like herd immunity.”

CBC