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OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

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surfaces after 24-28 hours of a primary enrichment. The MDA2 Listeria monocytogenes offers the benefits of extremely high sensitivity and high specificity for the detection of Listeria monocytogenes while reducing the overall time to presumptive results. The MDA2 Listeria monocytogenes also reduces the total analyst time required to obtain final results by implementing a single heat lysis step and cool step, followed up by a single transfer to molecular reaction tubes.The small foot print of the Molecular Detection System requires only minimal lab and bench space, making it easy to move the instrument or pair up additional MDS units to perform multiple MDA runs concurrently. The updated software is user friendly with easy to interpret results. The ability to examine Relative Light Unit (RLU) curves makes trouble shooting more streamline d if any problems occur while testing is being conducted.

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Discussion

There were no differences between the 24- and 26-hour enrichment time points for the environmental surfaces tested, therefore a 24-hour minimum enrichment will be recommended

for these matrices.

Conclusion

The 3M MDA2 - Listeria monocytogenes AOAC PTM validation study included an inclusivity/exclusivity, lot-to-lot/stability, robustness and matrix studies. The 3M MDA2 – Listeriamonocytogenes was compared to the USDA/FSIS-MLG 8.09, the FDA-BAM Chapter 10, the AOAC 993.12 or the ISO 11290-1/A1 reference methods for the detection of Listeriamonocytogenes . There were nosignificant differences between the 3M MDA2 - Listeriamonocytogenes method and the corresponding reference method for any of the matrices evaluated. The 3M MDA2 - Listeria monocytogenes demonstrated reliability as a rapid and sensitive method for the detection of Listeria monocytogenes for the following matrices: beef hot dogs (25 g), deli turkey (125 g), queso fresco (25 g), vanilla ice cream (25 g), 4% milk fat cottage cheese (25 g), 3% chocolate whole milk (25 mL), whole melon, romaine lettuce (25 g), bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken 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).

References

1. Food and Drug Administration Bacteriological Analytical Manual Chapter 10: Detection and Enumeration of Listeria monocytogenes in Foods . February, 2013. (Accessed January 2015) 2. United States Department of Agriculture Microbiological Laboratory Guidelines 8.09: Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry and Egg Products, and Environmental Samples . May 1 st , 2013. (Accessed January 2015) http://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG-

8.pdf?MOD=AJPERES