Danger: The COVID-19 rapid test kits being distributed in Alberta come with a warning — do not use at home and only use if you’re a medical expert.

These are the same kits experts across the country are urging people to test themselves with to make sure they’re not COVID-19 positive before work or a social function.

A Fort McMurray woman said she “became concerned” when she read the insert in the rapid test kit she picked up at a local Alberta Health Services (AHS) walk-in clinic.

Connie Shields, a retired dental hygenist who now runs MIB Moving in Fort McMurray, said she picked up her free Rapid Response test kit on Thursday and proceeded to read the product insert provided.

“I didn’t know where to go with this,” Shields told the Western Standard after finding what she called “some concerning things” on the insert.

Shields said the initial thing that concerned her was within the first paragraph on the product insert.

“This test is authorized for use at the Point of Care i.e., in patient care settings,” Shields said.

The third paragraph in the insert reads: “The Rapid Response COVID-19 Antigen Rapid Test Device is intended for use by trained laboratory personnel or health care professionals.”


Product insert in the Rapid Response COVID-19 test kits

Shields pointed to another “concerning” item listed in the ‘Precautions’ section stating: “This device contains material of animal origin and should be handled as a potential biohazard.”


Product insert in the Rapid Response COVID-19 test kits

Finally, under the ‘Limitations of the Test’ section, Sheilds pointed to item number nine which states: “This assay is not intended for home testing (or self-testing).


Product insert in the Rapid Response COVID-19 test kits

Confused and wanting answers, Shields said she contacted the manufacturer — Canadian biotechnology company BTNX Inc. — for clarification.

“Point blank, he told me these are not authorized for at-home use,” Shields told the Western Standard.

“His words were, ‘These are authorized by Health Canada under the interim order for professional use only in patient-care settings. It has not been authorized for home or self-testing,’ and he told me they have only applied for home-testing authorization.”

She also learned the tests contain bovine serum albumin, a protein derived from cows used as a protein concentration standard in lab experiments.

“This just seems concerning to me that this is what is being handed out to Albertans when they are not authorized for in-home use,” said Shields.

When theWestern Standard spoke with Yifan Wei, a BTNX Inc. customer support representative for the company, the same response was provided.

Wei said the company has only received approval from Health Canada for use in medical settings for the COVID-19 rapid response testing kits and said approval for at-home use is “coming very slowly.”

When asked about the “biohazard” concern, Wei said the tests only become a biohazard once they are used.

“Most provincial Ministry of Health websites have instructions on how to safely dispose of the used tests,” said Wei, adding he recommends covering the test up before throwing it away.

Although instructions on how to properly dispose of a rapid test can be found on the Canadian government’s website, the Western Standard was unable to find disposal instructions on the Alberta government’s rapid testing information page.

When asked if BTNX Inc. was concerned the government was handing out tests not yet authorized for in-home use, Wei said he wasn’t certain.

“Since it was Health Canada that gave the approval for use of the tests and it’s the government distributing them for in-home use, I would assume it’s ok, but I can’t say for sure,” said Wei.

According to the Government of Canada website, more than 425 million COVID-19 rapid test kits have been procured by the feds from 14 suppliers. Of those suppliers listed, the feds have purchased the most kits — 154.5 million — from BTNX Inc.

Free rapid test kits were made available to Albertans on December 17. More than 2.5 million tests — or 500,000 tests kits — were shipped to participating AHS and pharmacy locations and the province confirmed there’re more to come.

Alberta Health has so far refused comment.

Melanie Risdon is a reporter with the Western Standard

Reporter (Alberta)

Melanie Risdon is an Alberta Reporter for the Western Standard and Alberta Report based in the Calgary Headquarters. She has over 20 years’ experience in media at Global News, Rogers and Corus.

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