Introduced in December 2011, the 3M™ Molecular Detection System combines two innovative 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.”
The company developed the 3M Molecular Detection System and its test kits with the needs of its worldwide food processing clientele in mind, involving them early in the design process. As a result, a small but powerful technology was produced, capable of targeting and amplifying nucleic acid in enriched samples with excellent sensitivity and specificity.