GSD NovaPrime® Plus SARS-CoV-2 (1x96)

New Multiplex Real-Time RT-PCR assay intended for the qualitative detection of SARS-CoV-2 and the simultaneous identification of important spike mutations for detection of B.1.1.7 (Alpha), B.1.351 (Beta) and B.1.1.248 (P.1) (Gamma) lineages in one reaction.

Key Benefits

• Identification of SARS-CoV-2 with two independent gene targets (E and N gene) of the virus genome
• Detection of N501Y and/or E484K mutations in the spike protein
• Specimen types: nasal, nasopharyngeal, oropharyngeal
• Internal positive control to monitor successful extraction and amplification of sample material
• Validated PCR platforms: LightCycler^® 480 II (Roche), AriaDx^TM, and AriaMx^TM (Agilent Technologies)
• Fast results in less than 1.5 hours
• CE-IVD

Excellent Clinical Performance

Excellent analytical sensitivity with a limit of detection of 3 copies per reaction for E and N gene and 12 copies per reaction for the spike gene mutations. Diagnostic sensitivity of 96.1% compared to a standard SARS-CoV-2 screening RT-PCR assay. 100% and 97.9% agreement compared to genome sequencing for identification of the mutations E484K and N501Y, respectively.