• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Rapid Testing and Identification of Salmonella in Foods

Description: CFSAN scientists are developing, evaluating, and deploying rapid and portable technologies capable of identifying unique variants of Salmonella directly from foods and environmental surfaces as well as from pure cultures. Current methodologies can take over two weeks to complete the detection, serotyping, and molecular epidemiologic evaluation of bacterial pathogens associated with foodborne illness. The genetic detection technologies under development here will sharply decrease the investigatory time necessary to connect a suspect food source to a specific Salmonella strain. Such rapid approaches will aid in the prevention of foodborne illness associated with the US food supply by allowing for the timely response and removal of foods contaminated by this dangerous pathogen.

Accomplishment: This project spearheaded development and/or evaluation, and field deployment of several rapid and modern approaches designed to detect, identify, and track Salmonella strains associated with contamination of the food supply. Some of these methods have greatly enhanced the speed at which a food or environmental sample can be analyzed for contamination by Salmonella, a common and dangerous bacterial foodborne pathogen, or have provided a sharply improved ability to track foodborne Salmonella contamination back to its source. Several milestones from the project included: (1) spearheading deployment across FDA field laboratories of a CDC-designed rapid method for the same-day serotyping of Salmonella; (2) successfully reducing the number of days to detect, isolate, and identify Salmonella Enteritidis contamination of shell eggs from nine days to four with a detection limit as sensitive as a single cell; and (3) applying whole-genome sequencing of Salmonella to augment select foodborne outbreaks investigations. Next-generation sequencing of food-associated Salmonella will greatly improve our ability to identify and traceback sources of foodborne outbreaks involving this pathogen. Taken together, application of these strategies will allow for timely and more accurate response and removal of contaminated foods. In addition, many hundreds of the Salmonella genome sequences generated from this project aided in spawning “The 100K Genome Project”, an open-source database of foodborne pathogen genomes that is providing a critical roadmap forward for public-private development of investigative methods to quickly identify and trace food pathogens back to their source. Of note, “The 100K Genome Project’ recently won the Secretary’s Pick for the 2012 HHSInnovates Awards which recognize the most innovative breakthroughs in the Department of Health and Human Services for the year. See related links below.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Deployment and Field Validation of Salmonella Rapid Detection and Identification Methods

12/30/2010

Completed 1/6/2011

i. Deployment of IBIS biosensors into at least one FDA field laboratory or one State public health laboratory and corresponding training of relevant personnel from these sites

6/30/2010

Completed 10/1/2010

ii. Deployment of CDC Bioplex-based serotyping assay to regional FDA field laboratories and sister centers (i.e., CVM)

12/30/2010

Completed 1/6/2011

B. Development and Evaluation of Rapid and High-Throughput Detection and Assays for Salmonella

9/30/2011

(9/30/2012)

(12/31/2012)

Completed 10/4/2012

i. Complete first design iteration of the Salmonella species and subspecies IBIS biosensor detection plate for specific identification of strains directly from food matrices

3/30/2010

Completed 3/25/2010

ii. Successful automation and mechanization of the IBIS analytical process from overnight enrichments to final identification of Salmonella strains

6/30/2010

Completed 9/15/2010

iii. Completion of the first iteration of the IBIS food plate for detection of E. coli O157:H7, Salmonella, Listeria monocytogenes, and Shigella spp. from fresh cut produce

3/30/2011

Completed 3/29/2011

iv. Completion of design of multiplex real-time PCR assay for the ABI 7500 for rapid detection of Salmonella directly from overnight enriched produce

6/30/2011

Completed 10/15/2010

v. Completion of development of real-time PCR-based detection assay for S. Enteritidis directly from shell eggs

3/31/2011

Completed 12/16/2010

vi. Completion of evaluation and pre-collaborative validation of SE real-time PCR test

9/30/2011

(9/30/2012)

(12/31/2012)

Completed 10/4/2012

a. Complete processing of egg sample cultures and preparatory DNA pellets

4/30/2012

Completed 4/30/2012

b. Complete qPCR validation for 5 of the 10 planned validation trials

7/31/2012

Completed 8/10/2012

c. Complete additional qPCR validation trials and egg-based qPCR SE detection method

9/30/2012

Completed 9/5/2012

d. Complete statistical data analysis and coordination and compiling of pre-collaborative validation data for final report to ORS management and Center science leads

12/31/2012

Completed 10/4/2012

C. Development and/or Evaluation of Salmonella Molecular Serotyping Assays:

9/30/2011

Completed 10/5/2011

i. Completion of evaluation of Premitest PCR-array rapid serotyping assay

9/30/2010

Completed 1/11/2011

ii. Completion of preliminary evaluation of CDC Bioplex-based Salmonella serotyping scheme

9/30/2010

Completed 9/1/2010

iii. Use next generation whose genome sequencing approaches to build a database of complete genomes from the 50 Salmonella serotypes most often associated with human disease; use the database to design better tests

6/30/2011

Completed 10/5/2011

iv. Completion of the first iteration of the Salmonella serotyping plate for detection and identification of the top 20 Salmonella serovars associated with the food supply

9/30/2011

Completed 9/23/2011

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

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

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.