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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Summary Tables of No-Objection Letters Issued by FSIS for Non-O157 STEC Test Methods

These tables list the non-O157 Shiga Toxin-Producing Escherichia coli (non-O157 STEC) test methods that FSIS reviewed and has issued no-objection letters (NOLs). These NOLs were issued in an effort to increase public and industry awareness of available new technologies associated with the implementation of FSIS non-O157 STEC policy in 2012, at a time when reagents and reference strains that were critically necessary to validate STEC test methods were in short supply. The NOLs provide establishments with supporting documentation regarding the reliability of verification testing results.

Since that time, STEC test reagents and reference strains are now readily available and there are STEC detection methods commercially available that have been validated and certified through independent certification entities such as AOAC, AFNOR, MicroVal, or NordVal.

As a result of these positive developments, FSIS has discontinued its STEC test method review and NOL issuance process. However, the Agency encourages the test kit manufacturers to seek certification for STEC method validations through independent certification entities such as AOAC, AFNOR, MicroVal, or NordVal.

FSIS will continue to make available a list of test kits that have been validated for the detection of relevant foodborne pathogens on its website: Foodborne Pathogen Test Kits Validated by Independent Organizations. STEC detection methods that received NOLs and attain certification through independent certification entities will be included in the Foodborne Pathogen Test Kits Validated by Independent Organizations at the next quarterly update.

Non-O157 STEC Test Methods that Received No-Objection Letters and are Validated by an Independent Organization
Log Number Company Name Method Name
12-SMP-0848-N-A Biocontrol Systems Assurance GDS Top 7 STEC (eae) method
12-SMP-0849-N-A Biocontrol Systems Assurance GDS MPX Top 7 STEC method
12-SMP-0850-N-A IEH Laboratories IEH Non-O157 STEC detection and identification method
12-SMP-0858-N-A Bio-Rad Laboratories iQ Check™ VirX and iQ Check™ SerO STEC test methods
12-SMP-0860-N-A DuPont Qualicon BAX® System Real-Time PCR STEC Suite
12-SMP-0926-N-A Pall Corporation GeneDisc® Top 6 STEC test kit

 

Non-O157 STEC Test Methods that Received No-Objection Letters and are not Validated by an Independent Organization

Log Number Company Name Method Name
12-SMP-0854-N-A Life Technologies RapidFinder™ STEC Screening and Confirmation Assays for Beef Products
12-SMP-0855-N-A Neogen Corporation NeoSeek Approach to STEC Detection Identification *confirmatory test
12-SMP-0926-N-A Pall Corporation GeneDisc® Top 6 STEC test kit

For more information on test methods and their application, contact the test kit manufacturers listed.

For a complete listing of new technologies or for those interested in using a new technology, direct your request through askFSIS or you may contact the Risk, Innovations, and Management Staff directly at:

United States Department of Agriculture
Food Safety and Inspection Service
Risk, Innovations, and Management Staff
Patriots Plaza III
1400 Independence Ave., SW.: STOP 3782
Washington, DC 20250-3700
Tel: (301) 504-0884
Fax: (301) 245-4793
 
Last Modified Sep 05, 2014