The FDA provided data based on preliminary results of some antigen tests using patient samples containing live viruses.
The FDA has said it will continue to work with the National Institutes of Health (NIH) RADx program to further evaluate the performance of antigen tests using patient samples containing live viruses.
The SARS-CoV-2 virus has mutated over time, leading to genetic variation in the population of circulating virus strains during the COVID-19 pandemic. Viral mutations affect molecular, antigenic, and serological tests differently due to design differences in each test, the opinion added.
Source: The Nordic Page