Individuals are advised to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, according to a Food and Drug Administration (FDA) safety communication.

The FDA is recommending repeat testing whether or not individuals have COVID-19 symptoms to reduce the risk of a false negative result and to prevent spreading the SARS-CoV-2 virus to others. Individuals should repeat testing over a certain time period (eg, 2 to 3 days), particularly in those who are asymptomatic. All at-home COVID-19 antigen tests are currently authorized for repeat, or serial use.

The new guidance is based on the FDA’s latest study results, which showed that repeating a COVID-19 antigen test increased the chance of an accurate result in individuals with likely Omicron infection following a negative result. 

The FDA is recommending the following:

  • If the initial or repeat test is positive, follow the Centers for Disease Control and Prevention (CDC) guidance for individuals with COVID-19 and seek follow-up care with a health care provider.
  • If the initial test is negative with COVID-19 symptoms, repeat testing in 48 hours for a total of at least 2 tests. If the repeat test is still negative, an individual may choose to test again in 48 hours with an antigen test or consider getting a laboratory molecular-based test.
  • If the initial test is negative with no COVID-19 symptoms, repeat testing in 48 hours and then again 48 hours after the second negative test for a total of at least 3 tests. If the third test is negative and the risk of COVID-19 infection is still of concern, an individual may choose to test again with an antigen test or consider getting a laboratory molecular-based test.

Reference

At-Home COVID-19 antigen tests-take steps to reduce your risk of false negative: FDA safety communication. News release. US Food and Drug Administration. August 11, 2022. Accessed August 12, 2022. https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication