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From: The eUpdate, 9.18.2012

Molecular Detection Assay for E. coli O157 Receives AOAC-PTM Approval

Certification validates system’s ability to provide food processors with greater protection against foodborne illnesses

3M Food Safety has received AOAC-PTM Certification (#071202) for its new 3M™ Molecular Detection Assay for E. coli O157 (including H7) from the AOAC Research Institute’s Performance Tested Methods Program. The certification gives food processors greater assurance in safeguarding against pathogenic E. coli, a causative agent of foodborne illness responsible for an estimated 73,000 cases annually in the U.S., and second only to Salmonella in the number of outbreaks.

AOAC-PTM approval for 3M’s Salmonella and E. coli 0157 assays are the first of numerous validations for this product line, emphasizing the value of a pathogen detection solution that is fast, accurate, easy-to-use and affordable.

DeAnn Benesh, regulatory affairs specialist, 3M Food Safety

Introduced in December 2011, the 3M™ Molecular Detection System combines two technologies—isothermal DNA amplification and bioluminescence detection—to provide a fast and reliable method of pathogen detection in enriched food, feed and food process environmental samples. Determined to be equivalent to standard FDA and USDA reference methods for the detection of E. coli O157, this AOAC-PTM certification validates 3M’s new molecular approach for pathogen detection.

The PTM validation of E. coli O157 follows an earlier validation of the Salmonella assay from the AOAC Research Institute, which bases certification of methods on independent study results demonstrating that a given method meets its product performance claims as expressed in the product package insert. For the 3M Molecular Detection Assay E. coli O157 method PTM study, artificially contaminated samples were enriched and evaluated by the 3M Molecular Detection System as compared to the appropriate FDA or USDA FSIS reference method. Sample groups evaluated included raw ground beef, bagged spinach and sprouts, and no statistically significant differences were found in sample results between the 3M Molecular Detection Assay E. coli O157 (including H7) and reference methods.

“We are very excited about this validation and what it means for the 3M Molecular Detection System,” said DeAnn Benesh, regulatory affairs specialist with 3M Food Safety. “AOAC-PTM approval of 3M’s Salmonella and E. coli O157 (including H7) assays are the first of numerous validations for this product line, emphasizing the value of a pathogen detection solution that is fast, accurate, easy-to-use and affordable.”

For more information, visit www.3M.com/3MMolecularDetectionSystem/ECOAOAC.

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