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7

evaluated with all possible food products, food processes, testing protocols or with all

1

possible strains of bacteria.

2

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

3

The 3M MDA 2 –

Listeria

has only been evaluated for use with the enrichment media

4

specified in the Instructions for Use section.

5

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

6

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

7

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

8

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

9

be inserted into the 3M MDS instrument.

10

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

11

for the 3M MDS and the 3M MDA 2 –

Listeria

. Retain the safety instructions for

12

future reference.

13

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

14

Performpathogen testing in a properly equipped laboratory under the control of

15

trained personnel.Always follow standard laboratory safety practices, including

16

wearing appropriate protective apparel and eye protection while handling reagents

17

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

18

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

19

current industry standards.

20

Listeria monocytogenes

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

21

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

22

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

Listeria

tubes can

23

potentially contain pathogenic materials.Periodically decontaminate laboratory

24

benches and equipment (pipettes, cap/decap tools, etc.) with a 1- 5% (v:v in water)

25

household bleach solution or DNA removal solution. When testing is complete,

26

follow current industry standards for the disposal of contaminated waste. Consult the

27

Safety Data Sheet for additional information and local regulations for disposal.

28

To reduce the risks associated with environmental contamination:Follow current

29

industry standards for disposal of contaminated waste.

30

D.

Sample Enrichment

31

32

Foods

33

(a)

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

34

to equilibrate to ambient laboratory temperature (20-25

o

C).

35

(b)

Aseptically combine the enrichment medium and sample according to Table

2A

. For

36

all meat and highly particulate samples, the use of filter bags is recommended.

37

(c)

Homogenize thoroughly by

blending,

stomaching, or hand mixing for 2 ±0.2 minutes.

38

Incubate at 37 ±1°C according to Table A.

39