The CDC 2009 Influenza A H1N1 (Flu) Pandemic Real-time RT-PCR Panel including Pandemic Influenza A and Pandemic H1 Assays


CDC researchers have developed probes and primers for detecting the 2009 pandemic influenza A H1N1 virus in patient samples using real-time reverse transcription-polymerase chain reaction (rRT-PCR) methods. These primers and probes were originally developed in 2009 and were cleared by the FDA as part of a domestic human diagnostic testing panel in June 2010. These were also updated to increase specificity and/or sensitivity of the detection methods. The compositions and methods can be used to quickly identify 2009 pandemic influenza A (pdm InfA) and pandemic H1 (pdm H1), other influenza A virus sub-types (e.g., H3, H5, H7, and H9) and influenza B virus sub-types present in a sample. The CDC-developed probes and primers permit the rapid detection and/or discrimination of influenza virus subtype nucleic acids in initial clinical sample testing.

Potential Commercial Applications: Competitive Advantages:
  • Influenza A & pandemic influenza diagnostics using clinical specimens
  • Government and regional influenza surveillance programs
  • Quality control/quality assurance testing for influenza vaccine candidates
 
  • Assay allows for rapid universal detection and characterization of the 2009 A H1N1 pandemic influenza virus
  • High sensitivity and specificity
  • High-throughput sample screening and easily formatted as a kit or array
  • Faster than culturing and serological identification methods
  • Less laborious and more objective (quantitative) than immunoassays


Related Invention(s):
E-274-2013-0
E-331-2013-0
E-560-2013-0
E-562-2013-0


Inventors:

Stephen Lindstrom (CDC)  ➽ more inventions...

Bo Shu (CDC)  ➽ more inventions...

Kai-Hui Wu (CDC)  ➽ more inventions...

LaShondra Berman (CDC)  ➽ more inventions...

Christine Warnes (CDC)  ➽ more inventions...

Shannon Emery (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 62/432,340
US Application No. 15/834,555

Publications:
Shu B., et al. PMID 21593260
Shcherbik S., et al. PMID 24056261

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize:The CDC 2009 Influenza A H1N1 (Flu) Pandemic Real-time RT-PCR Panel including Pandemic Influenza A and Pandemic H1 Assays. For collaboration opportunities, please contact CDC TTO at tto@cdc.govor 1-404-639-1330.


Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-563-2013-0
Updated: Jul 25, 2018