Hollow Fiber Concentrating Pipette Tip for Improved Pathogen Detection in Foods

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$675,995.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
9R44FD003955-02
Award Id:
n/a
Agency Tracking Number:
R44FD003955
Solicitation Year:
2013
Solicitation Topic Code:
FDA
Solicitation Number:
PA12-088
Small Business Information
INNOVAPREP, LLC, 132 E MAIN ST, DREXEL, MO, 64742-8329
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
830979048
Principal Investigator:
. .
(816) 619-3375
apage@innovaprep.com
Business Contact:
ANDREW PAGE
(816) 619-3375
apage@innovaprep.com
Research Institution:
Stub




Abstract
Abstract 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 requireinnovative manufacturing processes that can be automated. InnovaPrep has secured the help of Dr. Pierre C t 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 basedgroundwork 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. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: InnovaPrep launched themarket disruptive Concentrating Pipette device in early 2012. In the proposed Phase II project the usable range of the system will be further extended through development of novel hollow fiber membrane filter Concentrating Pipette Tips and innovative manufacturing processes required to produce them at a low cost. The value of the combined system will be demonstrated and a basis for development of new methods will be established through development and evaluation of eleven concentration methods covering 11 high priority foods, five organisms, and six rapid detection methods.

* information listed above is at the time of submission.

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