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surfaces after 24-28 hours of a primary enrichment. The MDA2

Listeria monocytogenes

offers

1

the benefits of extremely high sensitivity and high specificity for the detection of

Listeria

2

monocytogenes

while reducing the overall time to presumptive results. The MDA2

Listeria

3

monocytogenes

also reduces the total analyst time required to obtain final results by

4

implementing a single heat lysis step and cool step, followed up by a single transfer to molecular

5

reaction tubes.The small foot print of the Molecular Detection System requires only minimal lab

6

and bench space, making it easy to move the instrument or pair up additional MDS units to

7

perform multiple MDA runs concurrently. The updated software is user friendly with easy to

8

interpret results. The ability to examine Relative Light Unit (RLU) curves makes trouble

9

shooting more streamline

d

if any problems occur while testing is being conducted.

10

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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

15

for these matrices.

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Conclusion

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The 3M MDA2 -

Listeria monocytogenes

AOAC PTM validation study included an

20

inclusivity/exclusivity, lot-to-lot/stability, robustness and matrix studies. The 3M MDA2 –

21

Listeriamonocytogenes

was compared to the USDA/FSIS-MLG 8.09, the FDA-BAM

22

Chapter 10, the AOAC 993.12 or the ISO 11290-1/A1 reference methods for the detection

23

of

Listeriamonocytogenes

. There were nosignificant differences between the 3M MDA2 -

24

Listeriamonocytogenes

method and the corresponding reference method for any of the

25

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 (Enviroswabenriched

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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)

37

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2.

United States Department of Agriculture Microbiological Laboratory Guidelines 8.09:

39

Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry and Egg

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Products, and Environmental Samples

. May 1

st

, 2013. (Accessed January 2015)

41

http://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-

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8.pdf?MOD=AJPERES

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AOAC Research Institute

Expert Review Pan l Use Only

OMAMAN-30 D/ PTM Validation Report 081501

OMA ERP - June 2016

ERP Use Only