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At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

Mary Wilson

Well-known member
Date Issued: August 11, 2022

The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.

After you use an at-home COVID-19 antigen test:

  • If you receive a positive result initially or after a repeat test, this means the test detected the SARS-CoV-2 virus and you most likely have COVID-19.
  • If you receive a negative result, the test did not detect the SARS-CoV-2 virus at the time of that test.
    • If you have COVID-19 symptoms, test again 48 hours after the first negative test, for a total of at least two tests.
      • If you get a negative result on the second test and you are concerned that you could have COVID-19, you may choose to test again 48 hours after the second test, consider getting a laboratory molecular-based test, or call your health care provider.
    • If you do not have COVID-19 symptoms and believe you have been exposed to COVID-19, test again 48 hours after the first negative test, then 48 hours after the second negative test, for a total of at least three tests.
      • If you get a negative result on the second test, test again 48 hours after the second test.
      • If you get a negative result on the third test and you are concerned that you could have COVID-19, you may choose to test again using an antigen test, consider getting a laboratory molecular-based test, or call your health care provider.
    • If you get a positive result on any repeat test with an at-home COVID-19 antigen test, you most likely have COVID-19 and should follow the CDC guidance for people with COVID-19.
https://www.fda.gov/medical-devices...-safety-communication?utm_source=CDRHTwitterD
 
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