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Appendix 8.8
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3M™ Molecular Detection Assay 2 -
Listeria monocytogenes
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MDA2LMO96
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PRODUCT DESCRIPTION AND INTENDED USE
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3M™ Molecular Detection Assay 2 -
Listeria monocytogenes
is used with the 3M™ Molecular
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Detection System for the rapid and specific detection of
Listeria monocytogenes
in enriched
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food and environmental samples.
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The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly
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amplify nucleic acid sequences with high specificity and sensitivity, combined with
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bioluminescence to detect the amplification. Presumptive positive results are reported in real-
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time while negative results are displayed after the assay is completed. Presumptive positive
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results should be confirmed using your preferred method or as specified by local regulations
(1, 2,
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3)
.
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The 3M Molecular Detection Assay 2 -
Listeria monocytogenes
is intended for use in a
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laboratory environment by professionals trained in laboratory techniques. 3M has not
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documented the use of this product in industries other than food or beverage. For example, 3M
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has not documented this product for testing water, pharmaceutical, cosmetics, clinical or
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veterinary samples. The 3M Molecular Detection Assay - 2
Listeria monocytogenes
has not
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been evaluated with all possible testing protocols or with all possible strains of bacteria.
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As with all test methods, the source, formulation and quality of enrichment medium can
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influence the results. Factors such as sampling methods, testing protocols, sample preparation,
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handling, and laboratory technique may also influence results. 3M recommends evaluation of
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the method including enrichment medium, in the user’s environment using a sufficient number of
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samples with particular foods and microbial challenges to ensure that the method meets the
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user’s criteria.
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3M has evaluated the 3M Molecular Detection Assay 2 -
Listeria monocytogenes
with Demi-
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Fraser Broth containing Ferric Ammonium Citrate. A typical formulation of this medium follows
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below.
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only