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3M MDA 2
Listeria
species and
L. monocytogenes
Collaborative Study
OMA-2016-MONTH-XXX
5/4/16
The 3M MDA 2 -
Listeria monocytogenes
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 MDA 2 -
Listeria
monocytogenes
has not been evaluated with all possible testing protocols or with
all possible strains of bacteria.
1.2
Summary of 3M MDA 2 -
Listeria monocytogenes
and 3M MDA 2 -
Listeria
PTM
and Precollaborative Studies
3M MDA2 -
Listeria
The 3M MDA2 -
Listeria
PTM validation study was performed in 2015. The aim
of this study was to demonstrate that the 3M MDA2 -
Listeria
method could detect
Listeria
species from selected environmental foods and surfaces as claimed by the
manufacturer: hot dogs (25g & 125g), salmon (25g), deli turkey (25g & 125g),
cottage cheese (25g), vanilla ice cream (25g), queso fresco (25g), spinach (25g),
melon (whole), raw chicken leg pieces (25g), raw chicken fillet (25g), concrete
(sponge, 225 mL & 100 mL), stainless steel (sponge, 225 mL), plastic
(Enviroswab, 10 mL).
There was no significant difference between the 3M MDA2 -
Listeria
method and
the reference method for any of the matrices tested using the probability of
detection (POD) analysis. All other PTM parameters (inclusivity, exclusivity,
ruggedness, stability and lot to lot) showed no significant differences. Approval
is pending for this study.
3M MDA2 -
Listeria monocytogenes
The 3M MDA2 -
Listeria monocytogenes
PTM validation study was performed in
2015. The aim of this study was to demonstrate that the 3M MDA2 -
Listeria
monocytogenes
method could detect
Listeria monocytogenes
from selected foods
and environmental surfaces as claimed by the manufacturer: hot dogs (25g &
125g), salmon (25g), deli turkey (25g & 125g), cottage cheese (25g), chocolate
milk (25 mL), vanilla ice cream (25g), queso fresco (25g), romaine lettuce (25g),
melon (whole), raw chicken leg pieces (25g), concrete (sponge, 225 mL & 100
mL), stainless steel (sponge, 225 mL), plastic (Enviroswab, 10 mL).
There was no significant difference between the 3M MDA2 -
Listeria
monocytogenes
method and the reference method for any of the matrices tested
using the probability of detection (POD) analysis.All other PTM parameters
(inclusivity, exclusivity, ruggedness, stability and lot to lot) showed no significant
differences. Approval is pending for this study.
1.3
Study Directors for Collaborative Study
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only