The FDA collaborated with the National Institutes of Health (NIH) and the University of Massachusetts Chan Medical School to design a comprehensive study using MyDataHelps to assess at-home COVID-19 antigen test performance. The study was funded by the NIH’s Rapid Acceleration Diagnostics (RADx) Program and included more than 7,000 participants. The results of the study were made available as a resource to all at-home COVID-19 antigen test manufacturers.
Using the results of this study, the FDA has updated their guidelines. Read the official FDA communication here.
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 increases the chance of an accurate result.