Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

Detection of COVID-19 in diagnostic specimens: The detection assay is a real-time RT-PCR test is only used for 2019 novel Coronavirus (SARS-CoV-2) nucleic acid detection. Results are for the identification of SARS-CoV-2 RNA. The RT-PCR test is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in the upper respiratory specimens such as nasopharyngeal swabs and oropharyngeal swabs. The real-time RT-PCR test is intended for use by qualified clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.