Accula™ SARS-CoV-2 Test

The Accula™ SARS-CoV-2 Test, which has received an Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA), is performed on the Accula™ Dock or the Silaris™ Dock and is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses nasal swab specimens, collected from patients suspected of COVID-19 by their healthcare provider. Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. The Accula SARS-CoV-2 Test using nasal swab specimens is also authorized to be distributed and used in patient care settings outside of the clinical laboratory environment.