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FDA/EUA approved SARS-CoV-2 qPCR detection kit - 100% specificity with ongoing serveillance, Lyophilized reagents, and more

by Erica D'Angelo

AFS Bio has partnered up with Primer Design (A Novacyt Group Company) to support the scientific community's testing efforts.  

 

Primer Design is a world-class leader in the manufacturing of qPCR assays and, during the pandemic, had distributed millions of COVID19 tests globally to over 230 countries  

 

We are bringing to the US the genesig COVID19 FDA-EUA assay, a kit with comprehensive advantages to improve  logistics and the workflow at the lab by delivering 100% specificity, among other key features we share as follows:  

 

  • 100% detection profile – genesig COVID19 detects all published strains of the RdRP region (ORF1ab gene) 
  • An ongoing surveillance program – a team of bioinformaticians analyzing daily published virus sequences to ensure this 100% detection profile is maintained. We share weekly the specificity statement, which after 49 weeks continues at 100% 
  • The surveillance program is the foundation to ensure the kit detects the new mutations mitigating the risk of false negatives 
  • No cold chain shipping required – the transport of the lyophilized components at ambient temperature making it readily available in a matter of hours at your door  
  • Results in <2hrs 
  • An open platform for any qPCR instrument
  • FDA/EUA approved for use with the following validated platforms:  
  • Roche LC480-II 
  • BioRad CFX Connect 
  • ABI 7500 

 

AFS Bio will also be including to the current product portfolio additional respiratory assays to support the recent clinical labs' needs. 

 

Primer Design (A Novacyt Group Company) has introduced to the global market the Winterplex assay (pending FDA/EUA approval), which distinguishes the COVID-19 ORF1ab and S gene from Influenza A, B, and RSV. As soon as the approval is confirmed, we will be sharing the news with you to consider including this discriminatory kit in your workflow. 

 

If you would like to receive more information or set up a quick presentation, please contact us to set up a meeting at your convenience.  

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