FDA: Some COVID test kits give bad results

Check your medicine cabinet. Some COVID test kits give bad results. That’s the word from the U.S. Food and Drug Administration (FDA). The agency is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to increased risk of false results.

History of Cue Health COVID test kits

The FDA issued Emergency Use Authorizations (EUAs) to Cue Health for two COVID-19 tests, both of which are intended to detect genetic material from SARS-CoV-2 virus in the nostrils. The Cue Health COVID-19 Test received initial EUA authorization on June 10, 2020. It is for use in point-of-care settings—as in a doctor’s office or hospital. The Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home.

Here’s where the problem comes in. The FDA issued a Warning Letter to the manufacturer, Cue Health, on May 10, 2024. An inspection showed Cue Health made changes to these tests. Those changes reduced the reliability of the tests to detect SARS-CoV-2 virus. It’s possible someone who actually has COVID could test negative. The FDA is warning home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to this increased risk of false results.

Here’s what to do

The FDA’s complete admonishment for in-home test users is this:

• Do not use any Cue Health COVID-19 Tests for Home and OTC Use that you may still have. Dispose of the entire test cartridge in the household trash.
• Talk to your health care provider if you were tested with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use, and you are concerned about your results.
• Consider retesting using a different COVID-19 test that received FDA authorization if you tested negative on the Cue Health COVID-19 Test for Home and OTC Use and still have symptoms.
• Report any problems you experience with the Cue Health COVID-19 Test for Home and Over the Counter (OTC) Use to the FDA, including suspected false positive or false negative results.

The FDA will keep the public informed if significant new information becomes available. If you think you had a problem with your device, the FDA encourages you to report the problem. Do so through the MedWatch Voluntary Reporting Form.

Have questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Related: Is it ethical to go camping after testing positive for COVID?

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