The Sienna COVID-19 Antigen Rapid Test Cassette does not differentiate between SARS-CoV and SARS-CoV-2 viruses. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
The Sienna COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care. The Sienna COVID-19 Antigen Rapid Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization.