GSD NovaTypeIV SARS-CoV-2 Assay

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CE marked, rapid and reliable RT-PCR assay for the differentiation of Omicron from other VOCs (Beta, Gamma, and Delta). GSD NovaType IV SARS-CoV-2 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.

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  • 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™, AriaDx™ (Agilent Technologies), CFX96 Touch™ (Bio-Rad)
  • Fast and reliable results within 1 hour
  • CE-IVD

Disease
COVID-19 is the official name for the new infectious disease declared pandemic in March 2020. It is a zoonotic disease that has quickly spread globally from person-to-person via respiratory droplets or through touching contaminated objects or surfa   

Symptoms
It can present as an asymptomatic infection, a mild respiratory tract infection, or a severe pneumonia with respiratory failure and even death. The incubation period ranges from 2-14 days (5 days on average), and symptoms can include fever, cough, and shortness of breath.

Mechanism of Infection
Primarily transmitted between people through respiratory droplets and contact routes