Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
SARS-CoV-2 is a novel coronavirus recently identified in humans. Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.1
The cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.