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1
The 3M Molecular Detection Assay 2 -
Listeria monocytogenes
method may generate
Listeria
2
monocytogenes
to levels sufficient to cause stillbirths and fatalities in pregnant women and the
3
immuno compromised, if exposed.
4
5
The user must train its personnel in current proper testing techniques: for example, Good
6
Laboratory Practices, ISO 17025
(4)
, or ISO 7218
(5).
7
8
To reduce the risks associated with a false-negative result leading to the release of
9
contaminated product:
10
•
Follow the protocol and perform the tests exactly as stated in the product instructions.
11
•
Store the 3M Molecular Detection Assay 2 -
Listeria monocytogenes
as indicated on the
12
package and in the product instructions.
13
•
Always use the 3M Molecular Detection Assay 2 -
Listeria monocytogenes
by the expiration
14
date.
15
•
Use the 3M Molecular Detection Assay
Listeria monocytogenes
for food and environmental
16
samples that have been validated internally or by a third party.
17
•
Use the 3M Molecular Detection Assay
Listeria monocytogenes
only for surfaces, sanitizers,
18
protocols and bacterial strains that have been validated internally or by a third party.
19
•
For an environmental sample containing Neutralizing Buffer with aryl sulfonate complex,
20
perform a 1:2 dilution before testing (1 part sample into 1 part sterile enrichment broth).
21
3M™ sample handling products which include neutralizing buffer: BPPFV10NB,
22
RS96010NB, RS9604NB, SSL10NB, XSLSSL10NB, HS10NB and HS119510NB.
23
24
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
AOAC Research Institute
Expert Review Panel Us Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only