Coronaviruses are enveloped, positive-sense and single-stranded RNA viruses with a nucleocapsid of helical symmetry and are composed of several proteins including the Spike (S), Envelope (E), Membrane (M) and Nucleocapsid (N) proteins. The S protein is very immunogenic with the Receptor Binding Domain (RBD) being the target of many neutralizing antibodies.

The 2019 SARS-CoV-2 emerged in the Chinese province of Hubei (Wuhan) in December 2019 and has been declared a pandemic on March 11, 2020. This outbreak has spread rapidly, with millions of reported cases and thousands of deaths worldwide.

BioFront Technologies has developed monoclonal antibodies to various coronaviruses, including both SARS-CoV-2 and non-SARS-CoV-2 (NL63, 229E) strains.

until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing