FDA Warns About At-Home COVID-19 Test

FDA issues warning regarding E25Bio at-home COVID-19 tests

(RxWiki News) The US Food and Drug Administration (FDA) is telling people not to use a particular at-home COVID-19 test.

The test in question is the E25Bio COVID-19 Direct Antigen Rapid Test. The FDA is warning against it because it hasn't been authorized for use and "may include false labeling representing that the test is authorized by the FDA," according to an FDA press release.

The agency noted that this test may also be found under the name E25Bio SARS-CoV-2 Antigen Test Kit. No one should use this test regardless of its name, the FDA noted.

Why is the FDA so concerned? For two key reasons:

  1. An unapproved test could provide false test results, meaning some people think they are not sick when they are really spreading the virus and delaying treatment.
  2. In some cases, the test provided instructions to collect samples from deep inside the nose or deep in the throat, the FDA said. Collecting samples in this way could seriously injure the user, and only trained professionals should engage in this behavior.

The FDA noted that it had not received reports of injuries or health problems associated with these tests. The agency said that anyone who has been tested with the E25Bio COVID-19 Direct Antigen Rapid Test should reach out to their health care provider if they have any concerns.

The FDA has recalled these COVID-19 tests and instructed health care providers and testing centers to stop using them. Still, it is possible to encounter one of these tests online or on store shelves, so carefully check the label.

If you have any questions about COVID-19 testing, reach out to your health care provider.

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Review Date: 
February 22, 2022