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U.S. Department of Health and Human Services

About FDA

Better Assessment of Food Borne Contamination and Disease

Description: This collaborative effort with ORA is to develop faster, more cost effective assays to identify food borne contamination and diseases.

Definition: These methods will identify pathogens in the food supply chain and will help to develop novel approaches that can be utilized at the site of food production and in testing facilities run by food producers or government agencies.

Public Health Outcome: Develop novel approaches that can be utilized by field personnel to detect food borne contamination and diseases.

Accomplishment: This project has qualified a flow cytometry platform capable of detecting individual pathogen cells in foods. Flow cytometry is a technique for counting and examining microscopic particles by suspending them in a stream of fluid and passing them by an electronic detection apparatus. Also developed are targeting reagents that allow the pathogen cells to stand out and be counted in the midst of food background that would otherwise cause a false positive signal. A new way of processing flow cytometric data has been invented that greatly increases the ability to distinguish real from false signals. Proof of concept first stage assays have been developed for detection of virulent E. coli O157, Listeria spp., Salmonella spp., Staphylococcus spp., non-typhoid Vibrio spp. The E. coli O157 has been validated to a FERN Level outside lab standard for use in nine food matrices. Two papers were prepared and submitted to a scientific journal.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Start validation with Regional Laboratory - Arkansas (ARL) for RAPID-B E. coli O157 assay in spinach

6/30/2010

Completed 6/6/2010

2. Complete assessment of RAPID-B E. coli O157 assay

8/30/2010

Completed 8/30/2010

3. Study methods to eliminate background issues for performing RAPID-B assays in extremely difficult matrices (e.g., milk)

9/30/2010

Completed 11/20/2010

4. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

10/11/2010

Completed 11/24/2010

5. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

11/27/2010

Completed 11/27/2010

6. Submit final technical report, manuscript, and/or publication to a scientific journal

12/20/2010

Completed 2/1/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

ORA

Office of Regulatory Affairs

assays

test or procedure to determine the components and composition of a substance

FERN

Food Emergency Response Network

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.