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h)
Dry double block heater unit.
– capable of maintaining 100 ± 1°C; or
a water bath
1
capable of maintaining 100 ± 1°C
2
i)
Refrigerator
. – capable of maintaining 2-8°C, for storing the 3M MDA2
3
j)
Computer
. – compatible with the 3M Molecular Detection System (instrument)
4
5
Safety Precautions
6
7
The user should read, understand and follow all safety information in the instructions for the 3M
8
Molecular Detection System and the 3M Molecular Detection Assay 2 -
Listeria
. Retain the
9
safety instructions for future reference.
10
11
As with all test methods, the source, formulation and quality of enrichment medium can
12
influence the results.
Factors such as sampling methods, testing protocols, sample preparation,
13
handling, and laboratory technique may also influence results. 3M recommends evaluation of
14
the method including enrichment medium, in the user’s environment using a sufficient number of
15
samples with particular foods and microbial challenges to ensure that the method meets the
16
user’s criteria.
17
The 3M Molecular Detection Assay 2 -
Listeria
method may generate
Listeria monocytogenes
to
18
levels sufficient to cause stillbirths and fatalities in pregnant women and the
19
immunocompromised, if exposed.
20
21
To reduce the risks associated with exposure to chemicals and biohazards:
•
It is strongly recommended that female laboratory staff be informed of the risk to a
developing fetus resulting from infection of the mother through exposure to
Listeria
monocytogenes
•
Perform pathogen
testing in a properly equipped laboratory under the control of trained
personnel
•
Always follow standard laboratory safety practices, including wearing appropriate protective
apparel and eye protection while handling reagents and contaminated samples
•
Avoid contact with the contents of the enrichment media and reagent tubes after amplification
•
Dispose of enriched samples according to current industry standards
22
Sample Preparation
23
3M recommends the use of Demi-Fraser Broth with FAC for the enrichment of food and
24
environmental samples. Table 1 presents guidance for the enrichment of food and environmental
25
samples. It is the user’s responsibility to validate alternate sampling protocols or dilution ratios
26
to ensure this test method meets the user’s criteria.
27
28
Foods
29
a)
Allow the Demi-Fraser Broth enrichment medium (includes FAC) to equilibrate to ambient
30
laboratory temperature.
31
b)
Aseptically combine the enrichment medium and sample according to Table 1. For all meat
32
and highly particulate samples, the use of filter bags is recommended.
33
c)
Homogenize thoroughly by blending, stomaching, or hand mixing for 2 ±0.2 minutes.
34
Incubate at 37 ±1°C according to Table 1.
35
36
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29 D/ PTM Validation Report 111501
OMA ERP - June 2016
ERP Use Only