GSD NovaPrime® TSP SARS-CoV-2 (COVID 19) 1x96

GSD NovaPrime® TSP SARS-CoV-2 (COVID 19) 1x96

GSD NovaType IV SARS-CoV-2 (1x96)

GSD NovaType IV SARS-CoV-2 is a rapid and reliable RT-PCR assay that differentiates Omicron from other VOCs (Beta, Gamma, and Delta). It specifically identifies S gene mutations K417N, E484K, and L452R. Screening for S gene mutations K417N and L452R allows for active surveillance of variants Omicron and Delta, respectively. Additionally, mutation E484K allows to identify patients potentially susceptible for specific antibody treatments.

Not available in the US.

 

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GSD NovaType IV SARS-CoV-2 is a rapid and reliable RT-PCR assay that differentiates Omicron from other VOCs (Beta, Gamma, and Delta). It specifically identifies S gene mutations K417N, E484K, and L452R. Screening for S gene mutations K417N and L452R allows for active surveillance of variants Omicron and Delta, respectively. Additionally, mutation E484K allows to identify patients potentially susceptible for specific antibody treatments.

Assay Features

  • • Parallel detection of S gene mutations L452R, E484K, and K417N, and discrimination of these mutations from the wildtype sequence at S gene position E484
  • • Specimen types: nasal, nasopharyngeal, oropharyngeal
  • • Should be performed after a first screening for SARS-CoV-2 RNA with a CE-IVD marked assay such as the GSD NovaPrime® TSP SARS-CoV-2 RT-PCR kit
  • • Validated PCR platforms: AriaMx and AriaDx (Agilent Technologies)
  • • Fast and reliable results within 1 hour
  • • RUO

Intended Use

The GSD NovaType IV SARS-CoV-2 is a research use only (RUO) real-time reverse transcription PCR (RT-PCR) assay designed for the simultaneous qualitative detection of the SARS-CoV-2 mutations K417N, L452R, and E484K within the spike (S) gene and discrimination of these mutations from the wildtype sequence at position E484. Detection of these mutations is intended to aid in the identification of SARS-CoV-2 variants of concern (VOC). Sample material should be genomic RNA extracted from human upper respiratory (nasal wash/swab, nasopharyngeal swab, oropharyngeal swab) specimen types that have previously tested positive for SARS-CoV-2 RNA by diagnostic RT-PCR methods e.g., GSD NovaPrime® TSP SARS-CoV-2. The GSD NovaType IV SARS-CoV-2 is expressly not intended for diagnosis of SARS-CoV-2 infections and not for use in diagnostic procedures. It is only designed to aid investigations related to the prevalence and frequency of virus variants.

Detection Channels

  Target Wildtype Beta Gamma Delta Omicron
  L452R - - - Texas Red/ROX -
  E484 HEX/VIC - - HEX/VIC -
  E484K - Cy5 Cy5 - -
  K417N - FAM - - FAM
  RNAse P ATTO425 ATTO425 ATTO425 ATTO425 ATTO425
More Information
SKU PCOV6191T
No. of tests 96
PCR cycler platforms AriaMxTM and AriaDxTM (Agilent Technologies)

Test Instructions