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Internal Control Nucleic Acid Molecule for Real-Time Polymerase Chain Reaction

The invention provides a PCR internal control system for use in both real-time PCR (also known as kinetic or Q-PCR) and conventional PCR. This flexible system has a number of novel design qualities which make it universally adaptable for use in virtually any real-time or conventional PCR assay, including RT-PCR and multiplex PCR applications, regardless of the organism/gene/nucleic acid being targeted. It provides the user/assay developer a choice of control product sizes, fluorogenic probe reporting systems, and thermal cycling options, allowing ease of incorporation into various assay formats and instrument platforms. This unique internal control also can be readily incorporated into virtually any existing quantitative multiplex real-time PCR assay. The invention also provides methods of using the internal control system and kits of the invention.

Michael Vickery
Angelo DePaola
George Blackstone

Intellectual Property:
U.S. Pat: 7,728,123 issued 2010-06-01
PCT Application No: PCT/US2004/015175
Related international patent applications filed

Additional information may be found in Vickery et al., "Detection and Quantification of Total and Potentially Virulent Vibrio parahaemolyticus Using a 4-Channel Multiplex Real-Time PCR Targeting the tl, tdh, and trh Genes and a Novel PCR Internal Control," published abstract, 103rd General Meeting of the American Society for Microbiology, May 18-23, 2003, Washington, DC.

Licensing Contact:
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-213-2003/0
Updated: August 6, 2015