GSD NovaType II SARS-CoV-2 (1x96 reactions)

This new CE-IVD marked Real-Time RT-PCR assay allows for the identification of relevant mutations associated with SARS-CoV-2 variants: B.1.1.7 (Alpha), B.1.351 (Beta), and P.1 (Gamma).

The assay is intended as a confirmatory test for potential mutants and should only be performed after first testing patient specimens for the presence of SARS-CoV-2 RNA with a CE-IVD marked screening assay such as the GSD NovaPrime^® SARS-CoV-2 (COVID-19) RT-PCR kit.

The gene of interest specific probes are labelled with the fluorophores FAM^TM, HEX^TM and ATTO647N (alternative to CY5^TM), thereby allowing parallel discrimination between S gene wildtype and mutations K417N, E484K and N501Y. As internal process control, the human Ribonuclease P (RNase P) gene is detected with probes labelled with the fluorophore ATTO425. The human RNase P gene primer and probe set serves as an internal positive control to monitor sample quality, RNA extraction, and for detection of inhibitors of the PCR reaction.

• Product upgrade: NovaType II allows for K417N identification as well as other VOC
• Parallel discrimination between S gene wildtype and mutations N501Y, E484K, and K417N
• Kit Contents: RT-PCR Enzyme Mix, Primer-Probe-Mix (for discrimination of variants), Primer-Probe-Mix (for detection of RNase P), Positive Control, Nuclease Free Water
• Specimen types: nasal wash/smear, nasopharyngeal wash/smear, oropharyngeal swab
• Validated PCR platforms: AriaMx^TM and AriaDx^TM (Agilent Technologies); additional thermal cyclers currently under validation
• Fast and reliable results with very high sensitivity
• Substitutes time-consuming sequencing
• CE-IVD