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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 –

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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 -

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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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