Intended Use
SARS-CoV-2 Antigen tests are immunoassays that use highly sensitive monoclonal antibodies to detect the presence of virus. With placing nasal/throat swab specimens directly into the assay’s extraction buffer or reagent, antigen tests can be used for screening in high-risk congregate
settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission.