At-home COVID-19 antigen tests-take steps to reduce your risk of false negative

Aug. 12, 2022
FDA safety communication.

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.

At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19. At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polymerase chain reaction (PCR) tests. This is especially true early in an infection or in people who do not have COVID-19 symptoms. Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period, such as 2-3 days, especially when the people using the tests don't have COVID-19 symptoms. Today, the FDA is highlighting the continued need for repeat, or serial testing when people get a negative result with an at-home COVID-19 antigen test, including recommending additional testing over a longer period of time.

Over the course of the COVID-19 pandemic, public health scientists have continued to learn about the SARS-CoV-2 virus and the impact of variants on diagnostic tests that detect SARS-CoV-2. Today's recommendations are based on the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result. COVID-19 diagnostic testing remains a cornerstone of our nation's fight against COVID-19. At-home COVID-19 antigen tests, while not perfect, provide a fast and convenient COVID-19 testing option.

FDA release