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), nasal, mid-turbinate and oropharyngeal (OP) swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The Aptima SARS-CoV-2 assay on the Panther™ 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.