For in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal(NS) swab specimens from individuals who are suspected of COVID-19 or for screening purposes.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease 2019 (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N).
The antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should be treated as presumptive, which 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, and confirmed with a molecular assay, if necessary, for patient management.