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industries. For example, 3M has not documented this product for testing drinking

1

water, pharmaceutical, cosmetics, clinical or veterinary samples. The 3M MDA2 –

2

Listeria monocytogenes

has not been evaluated with all possible food products, food

3

processes, testing protocols or with all possible strains of bacteria.

4

As with all test methods, the source of enrichment medium can influence the results.

5

The 3M MDA 2 –

Listeria monocytogenes

has only been evaluated for use with the

6

enrichment media specified in the Instructions for Use section.

7

The 3M™ Molecular Detection instrument is intended for use with samples that have

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undergone heat treatment during the assay lysis step, which is designed to destroy

9

organisms present in the sample. Samples that have not been properly heat treated

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during the assay lysis step may be considered a potential biohazard and should NOT

11

be inserted into the 3M MDS instrument.

12

The user should read, understand and follow all safety information in the instructions

13

for the 3M MDS and the 3M MDA 2 –

Listeria monocytogenes

. Retain the safety

14

instructions for future reference.

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To reduce the risks associated with exposure to chemicals and biohazards:

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Performpathogen testing in a properly equipped laboratory under the control of

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trained personnel.Always follow standard laboratory safety practices, including

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wearing appropriate protective apparel and eye protection while handling reagents

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and contaminated samples.Avoid contact with the contents of the enrichment media

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and reagent tubes after amplification.Dispose of enriched samples according to

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current industry standards.

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Listeria monocytogenes

is of particular concern for pregnant women, the aged and the

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infirmed. It is recommended that these concerned groups avoid handling this

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organism.After use, the enrichment medium and the 3M MDA 2 -

Listeria

25

monocytogenes

tubes can potentially contain pathogenic materials.Periodically

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decontaminate laboratory benches and equipment (pipettes, cap/decap tools, etc.) with

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a 1- 5% (v:v in water) household bleach solution or DNA removal solution. When

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testing is complete, follow current industry standards for the disposal of contaminated

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waste. Consult the Safety Data Sheet for additional information and local regulations

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for disposal.

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To reduce the risks associated with environmental contamination:Follow current

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industry standards for disposal of contaminated waste.

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D.

Sample Enrichment

34

35

Foods

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(a)

Allow the Demi-Fraser Broth enrichment medium (includes ferric ammonium citrate)

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to equilibrate to ambient laboratory temperature (20-25

o

C).

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(b)

Aseptically combine the enrichment medium and sample according to Table

2A

. For

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