Buyer beware: How to check if an at-home COVID test is FDA-approved

Tracking Coronavirus

FDA warning those selling unapproved at-home COVID tests

KANSAS CITY, Mo. — The United States Food and Drug Administration (FDA) approved its first at-home COVID-19 test in November 2020, and has authorized at least 400 additional tests and collection kits since then. But some companies are profiting from the pandemic by selling unproven and illegally marked products advertised as being effective in detecting or treating the coronavirus.

According to its website, the FDA has already sent at least 198 COVID-related warning letters to individuals and companies selling products without marketing approval, clearance, or authorization from the FDA. 

The letters advise companies selling misbranded products to take immediate corrective action, or legal action may be warranted. 

Despite FDA warnings, 60 of those companies, nearly 30%, are still advertising and selling fraudulent COVID-19 products, with some slapping an “FDA-approved” label on their webpage and unapproved products.

Russ Drury, director of preparedness, education, and safety at the Missouri State Public Laboratory, said the best place to find information on legitimate at-home tests is the FDA’s website.

“They have a list of all the emergency use authorization, or EUAs, for every single test that’s been allowed for COVID,” he said. “You can look through that list and if you don’t find it on that list then it has not been approved for testing and probably not something you should be looking into buying.” 

Some companies that have been warned, but continue to falsely advertise its products, include Avazo-Healthcare, Physician 360, Ikcon Investments, Anytime COVID Test LLC, Block Scientific, Sethi Laboratories, and Tresmonet Technologies.

Drury said he recommends at-home testing brands such as: Pixel by LabCorp, VaultHealth, EverlyWell, Picture by Fulgent, P23 Labs, Let’s Get Checked, Quest Diagnostics, Vitagene, and others.

“Each of those are actually home-collected PCR tests, so they’re considered a little more accurate, if you will,” he said.

A shelf with QuickVue At-Home over-the-counter COVID-19 tests.
A shelf with QuickVue At-Home over-the-counter COVID-19 tests.

Drury said licensed clinical improvement laboratories that collect FDA-authorized, at-home COVID-19 tests for detection are required to report the results to the state. He said those numbers get added to daily reporting and dashboards.

“We hope that’s the case, but we know there’s going to be some that slip through the cracks,” he said.

But tests that have yet to be FDA-approved might be sent to an unlicensed laboratory for detection, so it’s important to make sure one’s results get reported to the health department if this is the case, Drury said. 

“[Data] can make a big difference in containing disease and trying to minimize the impact of this horrendous virus,” he said.

Any entity providing testing on human clinical specimens is required to obtain a license from the Clinical Laboratory Improvement Amendments, which governs PCR tests.

Over-the-counter PCR tests seen on the shelves have likely already been FDA-authorized, so that means they are being sent to a licensed testing entity that then reports the test result to the state for data collection. 

Purchasing online, however, is a whole new ballpark.

If one were to test using a fraudulent product, their test result would not be reported to the state, unless they reported it themself.

“I would recommend anybody buying an online test, check the FDA approved emergency use authorization (EUA) to verify legitimacy,” Drury said in an email.

Over-the-counter rapid tests that show results in 15 to 30 minutes are also not reported to the state since they do not go to a laboratory for evaluation, so it is important individuals take the initiative to report these on their own as well.

Luckily, the state’s epidemiologist is in the process of making contact with pharmacies across Missouri to ensure the number of results reported on the dashboard aligns with the number of tests sold in stores, Drury said.

Amanda Finley, a former contact tracer and creator of the COVID-19 Long Haulers Discussion Group on Facebook, which now has 13.8 K members, said she believes she has contracted COVID-19 at least three times.

She said she took an at-home antibody test manufactured by Elabscience, which she purchased online, and it came back positive. However, she said she also took an at-home antigen test, manufactured by BinaxNOW, which came back negative.

According to the FDA’s website, Elabscience at-home tests have yet to be FDA-approved. However, antibody test results are not reported on the state’s dashboard anyway.

BinaxNOW, however, has been FDA-approved, which means Finley’s negative test result was reported to the state’s surveillance system.

Finley said she did not report her positive antibody result to a public health agency because she didn’t think anyone would care. She also said she trusts at-home testing, attributing some of her negative results to testing at the wrong time.

“People often will say, ‘Oh, I had an exposure yesterday,’ and they go out and test the next day,” she said. “Your viral load isn’t going to be high enough to detect it. You need to wait a little bit, as frustrating as it is.”

Jason Feldman, co-founder of Vault Health, one of the largest at-home PCR testing companies in the U.S., said the demand for at-home tests could rise this fall and winter, as more companies require unvaccinated employees to test on a regular basis.

“The reality is until this country is 75 to 80% vaccinated, testing is going to be part of the tool set that we have to keep our kids, our families, and our colleagues safe,” he said.

FDA-approved tests range anywhere from free to $119 and can be purchased at your nearest pharmacy.  

The Missouri Department of Health & Senior Services now offers free testing kits online that will be delivered to the home in two days. The test was authorized for emergency use by the FDA.

“I will never question the legitimacy of it [at-home testing],” Finley said. “I think it’s wonderful. The first round of anything is not going to be the best ever. We’ll learn from this and improve on it.”

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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