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3M MDA 2
Listeria
species and
L. monocytogenes
Collaborative Study
OMA-2016-MONTH-XXX
5/4/16
1.0
INTRODUCTION
The goal of this collaborative study is to validate the 3M™ MDA 2(MDA2)-
Listeria
and the 3M™ MDA 2 -
Listeria monocytogenes
using deli turkey (125g) and raw
chicken breast (25g). Test portions from 3 different contamination levels, including
negative controls, will be sent to approximately 12 laboratories who will perform a
comparison study between the 3M MDA2 methods and the USDA/FSIS
Microbiological Laboratory Guidebook Chapter 8.09 Revision 09 “Isolation and
Identification of
Listeria monocytogenes
from Red Meat, Poultry and Egg Products,
and Environmental Samples” (deli turkey and raw chicken breast). Data will be
evaluated using probability of detection (POD) analysis and the difference in the
POD at 3 contamination levels for both the candidate and reference method.
1.1
Description of the 3M MDAs
3M MDA2-
Listeria
3M™ MDA2 -
Listeria
is used with the 3M™ Molecular Detection System
(MDS) for the rapid and specific detection of
Listeria
species in enriched food
and environmental samples.
The 3M MDAs use loop-mediated isothermal amplification to rapidly amplify
nucleic acid sequences with high specificity and sensitivity, combined with
bioluminescence to detect the amplification. Presumptive positive results are
reported in real-time while negative results are displayed after the assay is
completed. Presumptive positive results should be confirmed using your preferred
method or as specified by local regulations.
The 3M MDA2 -
Listeria
is intended for use in a laboratory environment by
professionals trained in laboratory techniques. 3M has not documented the use of
this product in industries other than food or beverage. For example, 3M has not
documented this product for testing water, pharmaceutical, cosmetics, clinical or
veterinary samples. The 3M 2 -
Listeria
has not been evaluated with all possible
testing protocols or with all possible strains of bacteria.
3M MDA2 -
Listeria monocytogenes
3M™MDA2 -
Listeria monocytogenes
is used with the 3M™ MDS for the rapid
and specific detection of
Listeria
species in enriched food and environmental
samples.
The 3M MDAs use loop-mediated isothermal amplification to rapidly amplify
nucleic acid sequences with high specificity and sensitivity, combined with
bioluminescence to detect the amplification. Presumptive positive results are
reported in real-time while negative results are displayed after the assay is
completed. Presumptive positive results should be confirmed using your preferred
method or as specified by local regulations.
AOAC Research In titute
Expert Review Pane Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only