AOAC RI ERP Final Action Recommendations eBook

AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES AOAC Expert Review Panel Final Action Feedback

AOAC OFFICIAL METHOD 2013.02

DETECTION OF SALMONELLA SPECIES IN A VARIETY OF FOODS BY THE DUPONT™ BAX ® SYSTEM REAL- TIME PCR ASSAY FOR SALMONELLA -

METHOD APPLICABILITY Validated on a variety of foods and on stainless steel, ceramic tile and plastic surfaces

SAFETY CONCERNS No additional safety concerns have been identified since first action status was granted. All of the initial safety concerns still apply as described in the initial PTM study report: Kits - The reagents used in the BAX® Systemshould pose no hazards when used as directed. Dispose of lysate, PCR mixture and other waste according to your site practices. Cycler/detector - Only qualified laboratory personnel should operate the cycler/detector. Do not attempt to repair the instrument. Live power may still be available inside the unit even when a fuse has blown or been removed. Refer to the BAX® System User Guide for maintenance procedures when cleaning the unit or changing a fuse. The heating block can become hot enough during normal operation to cause burns or cause liquids to boil. Wear safety glasses or other eye protection at all times during operation. Enrichment Broths - All enrichment broths may contain varying pathogens whether they contain Salmonella or not and thus should be sterilized and disposed of using proper procedures following any culture-based confirmatory steps. Reference materials are readily available through proficiency testing programs administered by AOAC International and by the American Proficiency Institute in the United States. In Europe, many organizations provide reference materials for proficiency studies on detection of Salmonella . BAX® System End Users (including those who use the BAX® Real Time Salmonella test kit), regularly participate in these programs. SINGLE-LABORATORY VALIDATION Data from the method provider was previously considered by the AOAC Research Institute in the PTM approval process (leading to the method being designated PTM #081201 and by the AOAC International ERP as the Pre-collaborative study for Official Methods of Analysis approval. Subsequently a full collaborative study was conducted and considered by the ERP in granting first action status to the method which was designated as AOAC OMA 2013.02. REFERENCE MATERIALS

REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION

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