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Infectious Disease


Clarigene® SARS-CoV-2 RUOClarigene® SARS-CoV-2 RUO

The COVID-19 pandemic is an ongoing global pandemic. Coronaviruses are enveloped RNA viruses. SARS-CoV-2 is one of 7 total coronaviruses that commonly infect humans and is one of the 5 beta coronaviruses. It became apparent that there was a need for more accurate testing to correctly identify those people who are infected with COVID-19. Yourgene Health has developed a highly accurate* Clarigene® SARS-CoV-2 test. This is currently available for Research Use Only.

Key features:

  • Fast turnaround time after RNA extraction.
  • High accuracy with 100% specificity*
  • Human RNase P control designed as a true RNA control ensuring low false negatives
  • Assay uses N gene target which is SARS-CoV-2 specific so no cross reactivity with other Coronaviruses
  • Kit includes Mastermix, ROX, primers and probes
  • Compatible with RNA extracted from nasopharyngeal swabs
  • Assay can be easily adapted to an automatic workflow
  • RUO kit contains reagents for 96 samples
  • Compatible with qPCR machines such as Roche LightCycler, ABI 7500 and Quantstudio

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*Preliminary data

 

Clarigene® SARS-CoV-2 CE-IVDClarigene® SARS-CoV-2 CE-IVD

A CE-Marked RT-qPCR assay which detects the presence of SARS-CoV-2 viral RNA

Benefits:

  • High accuracy with >99.9% specificity*
  • Clinical sample testing presented 100% concordance when compared to gold standard reference**
  • Excellent sensitivity and precision (LOD of 5 copies per reaction); results are in concordance with an international external quality assessment panel
  • Dual viral RNA targets; SARS CoV–2 Envelope gene and Nucleocapsid (N) gene for a more reliable result
  • Assay uses N and E gene targets which are SARS-CoV-2 specific, meaning no cross reactivity with other Coronaviruses
  • Following wet lab testing, it is confirmed that the performance of the Clarigene® SARS-CoV-2 assay is not impacted by any currently known mutations in the VU-202012/01 strain. Click here for more details.
  • Human RNase P control designed as a true RNA control for lower false negatives
  • Internal control detects improper sample collection or poor-quality sample to give an invalid result, rather than giving a negative result
  • Fast turnaround time after RNA extraction
  • Simple and easy to set up
  • High throughput options available (automated version to follow)

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*In silico analysis did not identify any potentially amplifiable targets in other respiratory pathogens.

** 48/48 positive and 24/24 negative