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39

Appendix 8.8

1

2

3M™ Molecular Detection Assay 2 -

Listeria monocytogenes

3

MDA2LMO96

4

5

PRODUCT DESCRIPTION AND INTENDED USE

6

3M™ Molecular Detection Assay 2 -

Listeria monocytogenes

is used with the 3M™ Molecular

7

Detection System for the rapid and specific detection of

Listeria monocytogenes

in enriched

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food and environmental samples.

9

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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

12

bioluminescence to detect the amplification. Presumptive positive results are reported in real-

13

time while negative results are displayed after the assay is completed. Presumptive positive

14

results should be confirmed using your preferred method or as specified by local regulations

(1, 2,

15

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