GSD NovaPrime® Plus SARS-CoV-2 (1x96)
New CE-marked 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 (South Africa) and B.1.1.248 (P.1) (Gamma) lineages in one reaction.
Not Available in the US.
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.
• 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), AriaDxTM, and AriaMxTM (Agilent Technologies)
• Fast results in less than 1.5 hours
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.
|No. of tests||96|
|Time to Result||Less than 1.5 hours|
|PCR cycler platforms||LightCycler® 480 II (Roche Diagnostics), AriaMxTM and AriaDxTM (Agilent Technologies)|