AOAC ERP MICRO AUGUST 2018

OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

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0.50 was obtained with a 95% confidence interval of (0.24, 0.76). All 5 non-target test portions were negative with a POD value of 0.00 with a 95% confidence interval of (0.00, 0.43).

Discussion

The 3M ™ MDA 2 - Salmonella successfully recovered Salmonella species from all of the matrixes and environmental surfaces analyzed. Using POD analysis, no statistically significant differences were observed between the number of positive samples detected by the candidate method and the reference methods for all matrixes and environmental surfaces tested. The stability (lot-to-lot) study of the 3M ™ MDA 2 - Salmonella indicated consistency between the stability of each separate lot tested: an expired lot, a lot in the middle of its expiration, and a newly manufactured lot. The robustness study demonstrated that the 3M ™ MDA 2 - Salmonella was not sensitive to any of the changes by the seven different treatment combinations: lysis time, volume of the sample to the lysis solution, and volume of the lysis solution to the reaction tubes. One treatment combination did produce different results, but no statistical difference between The 3M ™ MDA 2 - Salmonella is quick and simple to perform, providing results in less than 2 hours post incubation for 30 sample replicates. The method offers the benefit of minimal possible contamination due to only 2 sample transfers are needed to perform the method. The small footprint and ability to link multiple Molecular Detection Systems to a single laptop computer offer high throughput. The MDS software is user friendly with the ability to track lot information and sample identification quickly and with ease. The added benefit of the real time treatments was observed.

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curves also improves any troubleshooting issues that may arise.

Conclusion

The results obtained by the POD analysis of the method comparison study demonstrated that there were no statistically significant differences between the number of positive samples detected by the candidate and the reference methods for all food matrixes and environmental surfaces analyzed. The data from these studies, within their statistical uncertainty, support the product claims of the 3M ™ MDA 2 - Salmonella in the selected food matrixes and environmental

AOAC Rese rch Institute Expert Review Panel Use Only

surfaces analyzed.

References

1. United States Department of Agriculture Microbiological Laboratory Guidelines 4.08: Isolation and Identification of Salmonella from Red Meat, Poultry, Pasteurized Egg, Catfish Products, and

Environmental Sponges . June 29 th , 2014. (Accessed April 2015)

http://www.fsis.usda.gov/wps/wcm/connect/700c05fe-06a2-492a-a6e1-3357f7701f52/MLG-

4.pdf?MOD=AJPERES