|
 
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test. If repeat testing is not performed after a negative result, an infection may be missed and people may unknowingly spread the SARS-CoV-2 virus to others, especially if they are not experiencing symptoms. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.
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.
"The FDA's new recommendations for at-home COVID-19 antigen tests underscore the importance of repeat testing after a negative test result in order to increase the chances of detecting an infection. These recommendations are based on sound scientific evidence and a result of the FDA’s collaboration with government and academic partners to assess at-home COVID-19 antigen test performance and ensure public health remains a top priority, particularly as the school season approaches. Throughout the pandemic, we have continued to learn about COVID-19 and the impact of variants on the performance of diagnostic tests designed to detect the virus, and we are committed to keeping the public updated so they can make the most informed health care decisions." – Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health
|
This safety communication provides:
- Recommendations for people who use at-home COVID-19 antigen tests.
- Background on the issue and the FDA's actions to address the issue.
- Instructions for reporting problems with at-home COVID-19 antigen tests to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education.
|
|
|
|