CoronaMelt Var - Model SARS-CoV-2 - Diagnostic Assay for the Detection and Genotyping

Results are for the detection of SARS-CoV-2 RNA that is detectable in nasopharyngeal swab and saliva samples during infection. CoronaMelt Var is able to provide additional information about variant identification. 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 Var is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

• CoronaMelt Var allows not only to identify the presence of the virus, but also to discern the different variants in a single process by tracking distinctive mutations. It is currently able to identify mutations associated with 3 variants of coronavirus – English (B.1.1.7)/Alpha, South African (B.1.351)/Beta and Brazilian (P.1)/Gamma – but it can be easily upgraded to extend the genotyping to new variants, once sequenced (the Delta variant is under development), as the virus is constantly evolving.
• Being labelled CE IVD, CoronaMelt Var can be used as a Tier 1 test for screening purposes (as majority of these tests are RUO and are used as a Tier 2 test for genotyping after tested positive for Covid).
• It also retains all the features of CoronaMelt, i.e. high level of accuracy, it is validated also with saliva samples and without RNA extraction, with significant costs and time savings.
• CoronaMelt Var uses a multi-target design to compensate for emerging SARS-CoV-2 variants and mutations. None of the mutations in B.1.351, P.1 and B.1.1.7, Delta and Omicron BA.1/BA.2 are known to affect our COVID-19 portfolio of tests.*