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7

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

1

The 3M MDA 2 –

Listeria monocytogenes

has only been evaluated for use with the

2

enrichment media specified in the Instructions for Use section.

3

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

4

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

5

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

6

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

7

be inserted into the 3M MDS instrument.

8

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

9

for the 3M MDS and the 3M MDA 2 –

Listeria monocytogenes

. Retain the safety

10

instructions for future reference.

11

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

12

Performpathogen testing in a properly equipped laboratory under the control of

13

trained personnel.Always follow standard laboratory safety practices, including

14

wearing appropriate protective apparel and eye protection while handling reagents

15

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

16

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

17

current industry standards.

18

Listeria monocytogenes

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

19

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

20

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

Listeria

21

monocytogenes

tubes can potentially contain pathogenic materials. Periodically

22

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

23

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

24

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

25

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

26

for disposal.

27

To reduce the risks associated with environmental contamination:Follow current

28

industry standards for disposal of contaminated waste.

29

D.

Sample Enrichment

30

31

Foods

32

(a)

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

33

to equilibrate to ambient laboratory temperature (20-25

o

C).

34

(b)

Aseptically combine the enrichment medium and sample according to Table 2. For all

35

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

36

(c)

Homogenize thoroughly by blending, stomaching, or hand mixing for 2 ±0.2 minutes.

37

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

38

39

AOAC Research Ins itute

Expert Review Panel Use Only

OMAMAN-30 A/ Collaborative Study Manuscript

OMA ERP June 2016

ERP Use Only