Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The Aptima® SARS-CoV-2 assay is a nucleic acid amplification in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and nasal swabs obtained from individuals suspected of COVID-19 infection, exhibiting signs and symptoms of a respiratory tract infection. The Aptima SARS-CoV-2 assay on the Panther® and Panther Fusion® system is intended for use by clinical laboratory personnel specifically instructed and trained in the operation of the Panther and Panther Fusion systems and in vitro diagnostic procedures.