SARS-CoV-2 Antigen Detection Kit(Immunofluorescence)

Product Information

Basis Information

The product is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal swab, saliva specimens and superficial nasal swab directly from individuals who are suspected of COVID- 19 by their healthcare provider.

Results are to identify SARS-CoV-2 nucleocapsid protein antigen. 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 should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID- 19 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 Antigen test kit is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.