1.Intended Use This CoviDxTM Assure is an in-vitro multiplex RT-PCR qualitative assay for the specific detection of SARS-CoV-2 in human respiratory samples. CoviDxTM Assure primer and probe sets were designed for the detection of E-gene and N-gene of SARS-CoV-2, along with an internal control for Human RNase P in a single tube assay, based on Berlin protocol.