Results are for the detection of SARS-CoV-2 RNA that is detectable in nasopharyngeal swab samples during infection. Positive results are indicative of SARS-CoV-2 RNA detection, but may not represent the presence of transmissible virus. 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. CoronaMelt is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.