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portions, there were 0 presumptive positives out of 5 replicates. See Table 17 for robustness
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results.
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3
Independent Laboratory Observations
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The results of this study demonstrate the ability of the MDA2
-
Listeria monocytogenes
to detect
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the presence of
Listeria monocytogenes
in various food matrices and select environmental
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surfaces after 24-28 hours of a primary enrichment. The MDA2
-
Listeria monocytogenes
offers
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the benefits of extremely high sensitivity and high specificity for the detection of
Listeria
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monocytogenes
while reducing the overall time to presumptive results. The MDA2
-
Listeria
10
monocytogenes
also reduces the total analyst time required to obtain final results by
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implementing a single heat lysis step and cool step, followed up by a single transfer to molecular
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reaction tubes.The small foot print of the Molecular Detection System requires only minimal lab
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and bench space, making it easy to move the instrument or pair up additional MDS units to
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perform multiple MDA runs concurrently. The updated software is user friendly with easy to
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interpret results. The ability to examine Relative Light Unit (RLU) curves makes trouble
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shooting more streamlined if any problems occur while testing is being conducted.
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Discussion
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There were no differences between the 24- and 26-hour enrichment time points for the
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environmental surfaces tested, therefore a 24-hour minimum enrichment will be recommended
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for these matrices.
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Conclusion
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The 3M MDA2 -
Listeria monocytogenes
AOAC PTM validation study included an
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inclusivity/exclusivity, lot-to-lot/stability, robustness and matrix studies. The 3M MDA2 –
28
Listeriamonocytogenes
was compared to the USDA/FSIS-MLG 8.09, the FDA-BAM
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Chapter 10, the AOAC 993.12 or the ISO 11290-1/A1 reference methods for the detection
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of
Listeriamonocytogenes
. There were nosignificant differences between the 3M MDA2 -
31
Listeriamonocytogenes
method and the corresponding reference method for any of the
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matrices evaluated. The 3M MDA2 -
Listeria monocytogenes
demonstrated reliability as a
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rapid and sensitive method for the detection of
Listeria monocytogenes
for the following
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matrices: beef hot dogs (25 g), deli turkey (125 g), queso fresco (25 g), vanilla ice cream (25
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g), 4% milk fat cottage cheese (25 g), 3% chocolate whole milk (25 mL), whole melon,
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romaine lettuce (25 g), bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken
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leg pieces (25 g), sealed concrete (sponge enriched in 100mL), plastic (Enviro
sS
wab
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enriched in 10 mL), stainless steel (sponge enriched in 225 mL).
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References
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1.
Food and Drug Administration Bacteriological Analytical Manual Chapter 10:
Detection and
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Enumeration of Listeria monocytogenes in Foods
. February, 2013. (Accessed January 2015)
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