The QuantuMDx SARS-CoV-2 real-time RT-PCR Detection Assay is a qualitative RT-PCR assay for the detection of SARS-CoV-2 genomic RNA from upper respiratory specimens (e.g. nasopharyngeal or oropharyngeal swabs, etc.). Two kit sizes are available, containing either 1,000 and 10,000 tests . The assay detects 3 unique SARS-CoV-2 loci and utilizes a unique RNAse P locus as a specimen process control. Data interpretation is provided as Positive, Negative, and Invalid. The assay has been validated on the Bio-Rad CFX96 and the Qiagen Rotor-Gene Q utilizing nucleic acid extracts from the Qiagne QIAamp Viral RNA Mini Kit.