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Office of Regulatory Science
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Center for Food Safety and Applied Nutrition
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Food and Drug Administration
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5100 Paint Branch Parkway, Rm 3E-021
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College Park, MD 20740
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Expert Reviewers
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Michael Brodsky
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Brodsky Consultants
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73 Donnamora Crescent
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Thornhill, Ontario L3T 4K6
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Canada
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Wayne Ziemer
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USDA (Retired)
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1301 Kristen Lane
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Loganville, GA 30052
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General Information
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Salmonella
are commonly found in raw food products that come from animals, such as eggs, egg
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products, meat, meat products, unpasteurized milk or dairy products, or are found on products that
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have become contaminated through contact with humans or animals. Common causes of salmonella
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poisoning are contaminated water, contaminated surfaces and undercooked foods, such as chicken
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and eggs. It is estimated that from 2 to 4 million cases of salmonellosis occur in the U.S. annually. The
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incidence of salmonellosis appears to be rising both in the U.S. and in other industrialized nations.
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Traditional culture methods for Salmonella detection can take as long as 5 days to provide results. The
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3M Molecular Detection Assay
Salmonella
was developed to provide rapid and specific detection of
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Salmonella
in enriched food and feed samples.
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Principle
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3M Molecular Detection Assay
Salmonella
method is intended for use with the 3M Molecular
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Detection System for the rapid and specific detection of
Salmonella
spp. in food, food-related, and
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environmental samples after enrichment. The 3M Molecular Detection Assay
Salmonella
Test uses
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isothermal amplification of unique DNA target sequences with high specificity, efficiency and rapidity,
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and bioluminescence to detect the amplified sequences. Presumptive positive results are reported in
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real-time while negative results will be displayed after the assay is completed.
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The limit of detection of a method is defined as the lowest concentration point where reliable
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analytical results can be obtained. This can vary with different serotypes. For the 3M Molecular
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Detection Assay
Salmonella
this has been demonstrated to be 1-5 CFU/ 25 g of sample or 1-5 CFU/
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swab.
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The 3M Molecular Detection Assay
Salmonella
is used for food and feed matrices and has been
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validated using representative samples of the following matrices: raw ground beef, cooked breaded
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chicken, raw shrimp, bagged spinach, wet pet food, and pasteurized liquid whole egg.
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