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Methods and Compositions for Selectively Enriching Microbes

Description of Technology:

The described technology provides markedly improved enrichment of E. coli O157:H7, Shiga toxin-producing E. coli (STEC) and Shigella. This improved enrichment can be complimentary to, and enhance performance of, existing nucleic acid or antibody based detection methods. In addition, the improved enrichment method facilitates isolation of pathogens following positive results by any nucleic acid or antibody based test. Such isolation by cultural methods is essential for epidemiology, antibiotic sensitivity testing and other biochemical characterization.

Current enrichment protocols are often inadequate as they allow large numbers of interfering bacteria to grow. This makes it necessary for microbiologists to screen hundreds of presumptive colonies to achieve successful isolation (A Khan et al., Emerg Infect Dis. 2002 Jan; 8:54-62). The new technology is a simple two step process. The sample is first placed in a low pH solution for a brief period and then transferred to a medium permitting maximal growth of target bacteria. With this new technology there is no risk of false negative results due to inadvertent inhibition of target bacteria by novobiocin, tellurite, cefixime, or other additives commonly used in existing enrichment procedures.

This new technology has been shown to be effective with food, water, environmental and clinical samples. Its components are inexpensive and microbiologists are not required to impede their workflow by adding separate selective agents at specified intervals such as four or six hours.

Applications:

Improved detection of E. coli O157:H7, STEC and Shigella in:
  • Clinical samples
  • Food
  • Beverages
  • Dairy
  • Water
  • Wastewater
  • Environmental
  • Veterinary Samples
Advantages:
  • Simple
  • Inexpensive
  • Requires no addition of antibiotic or other inhibitor solutions
  • Reduces interfering bacterial competitors and makes detection of target pathogens easier
Market:

Manufacturers of Microbiological Media and Tests for use in:
  • Hospitals
  • Clinics
  • Food and Beverage Manufacturers
  • Testing Laboratories
  • Dairies
  • Veterinary Clinics
  • Water Testing Laboratories
  • Water and Wastewater Facilities
Inventors:

Michael A. Grant (FDA)

Publications:
  1. MA Grant. Comparison of Escherichia coli O157:H7 enrichment in spiked produce samples. J Food Prot. 2008 Jan;71(1):139-145. [PubMed abs]
  2. MA Grant. Comparison of a new enrichment procedure for Shiga toxin-producing Escherichia coli with five standard methods. J Food Prot. 2005 Aug;68(8):1593-1599.
  3. MA Grant. Improved laboratory enrichment for enterohemorrhagic Escherichia coli by exposure to extremely acidic conditions. Appl Environ Microbiol. 2004 Feb;70(2):1226-1230. [PubMed abs]
  4. Submitted for publication – two papers demonstrating effectiveness of new enrichment procedure with clinical and environmental samples.
Patent Status:

DHHS Reference No. E-228-2002/0 --
U.S. Provisional Application No. 60/435,639 filed 20 Dec 2002
International Application No. PCT/US03/40806 filed 19 Dec 2003, which published as WO 2004/111180 on 23 Dec 2004
U.S. Patent Application No. 10/539,765 filed 20 Jun 2005

Licensing Status:

Available for exclusive or non-exclusive licensing.

Collaborative Research Opportunity:

The FDA is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods for detecting pathogenic bacteria, especially E. coli O157:H7, Shiga toxin-producing E. coli (STEC) and Shigella. Please contact Alice Welch at Alice.Welch@fda.hhs.gov for more information.

Portfolios:

Devices/Instrumentation - Diagnostics, other
Infectious Diseases - Diagnostics, bacterial
Internal Medicine - Diagnostics, other

For additional information, please contact:

RC Tang JD, LLM
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville MD 20852
Phone: 301/435-5031
Fax: 301/402-0220
Email: tangrc@mail.nih.gov




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