COVID-19 Antigen

The COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay
for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab
specimens from individuals with suspected SARS-CoV-2 infection in conjunction with
clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally
detectable in upper respiratory 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.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the
sole basis for treatment or patient management decisions. Negative results should be
treated as presumptive and confirmed with a molecular assay, if necessary for patient
management. 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.