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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
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.
REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION
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