Stay up to date with notifications from The Independent

Notifications can be managed in browser preferences.

FDA warns this brand of at-home Covid test may give false results

Anyone who has used these tests in the past two weeks should re-test to confirm ‘questionable results’

Justin Vallejo
New York
Tuesday 18 January 2022 14:20 EST
Comments
PCR tests scrapped for asymptomatic Covid cases from 11 January

Your support helps us to tell the story

From reproductive rights to climate change to Big Tech, The Independent is on the ground when the story is developing. Whether it's investigating the financials of Elon Musk's pro-Trump PAC or producing our latest documentary, 'The A Word', which shines a light on the American women fighting for reproductive rights, we know how important it is to parse out the facts from the messaging.

At such a critical moment in US history, we need reporters on the ground. Your donation allows us to keep sending journalists to speak to both sides of the story.

The Independent is trusted by Americans across the entire political spectrum. And unlike many other quality news outlets, we choose not to lock Americans out of our reporting and analysis with paywalls. We believe quality journalism should be available to everyone, paid for by those who can afford it.

Your support makes all the difference.

The US Food and Drug Administration has warned of a “high risk” of false-positive or false-negative results from an unapproved at-home Covid-19 test kit.

In a statement urging people to stop using rapid antigen tests from LuSys Laboratories, the agency said it had not adequately established the performance of the company’s Antigen Test (Nasal/Saliva) or its IgG/IgM Antibody Test.

“The FDA believes there is likely a high risk of false results when using these tests,” the statement said.

“Neither test has been authorised, cleared, or approved by the FDA for distribution or use in the United States.”

The tests may also be sold under the alternate names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx, the FDA said.

The agency said the tests have been distributed for use in both a laboratory setting at for at-home use, adding that any healthcare provider that has purchased or used the tests to re-test anyone “questionable results” from the past two weeks. Anyone who has used the kits at home is advised to contact their health care providers.

The FDA previously warned using LuSys Laboratories unapproved tests, recalling 2,000 Ebola Virus One-Step Test Kits in 2015.

Last year, the agency warned about Covid-19 tests from Innova Medical Group and Lepu Medical Technology, which delivered unapproved kits to pharmacies and healthcare providers.

Join our commenting forum

Join thought-provoking conversations, follow other Independent readers and see their replies

Comments

Thank you for registering

Please refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged in