Hollow Fiber Concentrating Pipette Tip for Improved Pathogen Detection in Foods

Information

  • Research Project
  • 8727299
  • ApplicationId
    8727299
  • Core Project Number
    R44FD003955
  • Full Project Number
    5R44FD003955-03
  • Serial Number
    003955
  • FOA Number
    PA-12-088
  • Sub Project Id
  • Project Start Date
    9/1/2013 - 11 years ago
  • Project End Date
    8/31/2015 - 9 years ago
  • Program Officer Name
  • Budget Start Date
    9/1/2014 - 10 years ago
  • Budget End Date
    8/31/2015 - 9 years ago
  • Fiscal Year
    2014
  • Support Year
    03
  • Suffix
  • Award Notice Date
    8/28/2014 - 10 years ago
Organizations

Hollow Fiber Concentrating Pipette Tip for Improved Pathogen Detection in Foods

DESCRIPTION (provided by applicant): Rapid microbiological methods offer great potential for increasing the reliability of pathogen detection in foods while reducing labor costs and product hold times, however, small analysis volumes limit the usefulness of these methods. Pre-enrichment is often used to overcome this limitation, but the significant time advantage of these methods is then lost. Mechanical concentration or enrichment approaches hold promise, but their development has lagged. In an effort to fill this void, InnovaPrep has developed a rapid concentration approach with single-use membrane filter tips and a novel elution process to allow for straightforward, user- friendly concentration of pathogens from foods while eliminating cross contamination between samples. Through internal and Phase I project support InnovaPrep was able to release a commercial Concentrating Pipette (CP) device and flat membrane filter Concentrating Pipette Tips (CPTs) in March 2012 and the response has been strong - with 35 devices sold, two leased, and five loaned for evaluation. During Phase I and during the early months after release of the commercial CP system, it became clear that the approach was viable and that the market was ready to embrace this approach. It was, however, also apparent that the useful range of the current device was somewhat limited due to a relatively small membrane filter surface area of only 8.5 cm2. In particular, the upper sample volume size can be significantly limited when working with difficult food matrices. In Phase II, InnovaPrep proposes development of hollow fiber membrane filter CPTs (hf-CPTs) with up to 15 times more surface area than current flat membrane filter CPTs. This increased surface area will dramatically expand the useful range of the device, allowing for larger process volumes, greater concentration factors, reduced development time for new food methods, as well as allowing for the introduction of viral CPTs. Producing hf-CPTs at costs that fit the requirements of the food safety laboratory will require innovative manufacturing processes that can be automated. InnovaPrep has secured the help of Dr. Pierre Cote and Mr. Steven Pederson, two experts in the field of hollow fiber module design and production, to assist in the development of a novel static potting method in order to achieve these goals. A novel static potting method and new manufacturing processes will be developed and 3,500 beta hf-CPTs will be produced for use during the final Aims of the project. Using beta hf-CPTs, InnovaPrep will develop eleven concentration methods covering 11 high priority foods, five organisms, and six rapid detection methods. The developed methods will demonstrate the value of the CP over a range of food types, organisms and rapid detection methods and lay a broad based groundwork that serves as a starting point for development of additional methods by other users. The developed methods will be evaluated by at the University of Missouri - Columbia.

IC Name
FOOD AND DRUG ADMINISTRATION
  • Activity
    R44
  • Administering IC
    FD
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    352760
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
    FDA:352760\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    INNOVAPREP, LLC
  • Organization Department
  • Organization DUNS
    830979048
  • Organization City
    DREXEL
  • Organization State
    MO
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    647428329
  • Organization District
    UNITED STATES