Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a recently identified coronavirus strain responsible for the Coronavirus Disease 2019 (COVID-19) and pandemic. The virus infects human cells through interaction between angiotensin-converting enzyme 2 (ACE2) on respiratory cells and spike or S-protein on the outer envelope of the virion particle.
The SARS-CoV-2 Protein Antigen assay is intended for Research Use Only to detect the presence or absence of the nucleocapsid protein antigen from the SARS-CoV-2 virus in nasopharyngeal swab specimens. This nucleocapsid protein (or N protein) is elevated in respiratory fluids during the initial acute phase of the infection. This N protein elevation can be used to measure SARS-CoV-2 infection in its earliest stages, prior to the development of a significant anti-SARS-CoV-2 antibody response.