Lead Inventors
Bo Shu (CDC)
Stephen Lindstrom (CDC)
Co-Inventors
Christine Warnes (CDC)
Kai-Hui Wu (CDC)
LaShondra Berman (CDC)
Shannon Emery (CDC)
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.
Commercial Applications
- Influenza A & pandemic influenza diagnostics using clinical specimens
- Government and regional influenza surveillance programs
- Quality control/quality assurance testing for influenza vaccine candidates
Competitive Advantages
- 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