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with 95% confidence intervals of (-0.03, 0.00) was obtained between presumptive and confirmed

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results

indicating the difference between presumptive and confirmed methods was not

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statistically significant at the 0.05 probability level.indicating no statistically significant

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difference between the presumptive and confirmed results.

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Detailed results of the POD statistical analysis are presented in Table 2016.2B and Figures 1C-

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1D.

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Discussion

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No negative feedback was provided by the collaborating laboratories in regard to the

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performance of the 3M MDA 2-

Listeria monocytogenes

method.For the raw chicken breast fillet,

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Laboratory 10 reported isolating

Listeria monocytogenes

from two un-inoculated control samples.

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The isolates were sent for further identification and it was determined that they were the same

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strain as the inoculating organism, indicating that cross contamination of the sample occurred.

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Due to the fact that cross contamination occurred, just cause for removal of the data was

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established and the data generated by Laboratory 10 was therefore not included in the statistical

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analysis.

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Overall, the data generated during this evaluation demonstrates the reproducibility of this new

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method. For the deli turkey analysis, the POD statistical analysis indicated

the difference

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between the candidate method and reference method was not statistically significant at the 0.05

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probability level. And thethatno statistically significant difference between the candidate method

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and the reference methodor between the presumptive and confirmed results difference between

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presumptive and confirmed candidate method was not statistically significant at the 0.05

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probability

level.of

the candidate method was obtained.

For raw chicken breast fillet, a

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statistically significant difference was observed between the reference and the alternative

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method.

The dLPOD data indicated The dLPOD being significantly greater than zero showed an

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observed higher proportion of positive results by the candidate method than the reference

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method.a positive correlation in data indicating more recovery of the target analyte by the

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candidate method.

One possible contribution

for the higher observed proportion positive resultsto

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the higher level of recovery

observed with the 3M MDA 2 –

Listeria monocytogenes

method was

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the use of Demi-Fraser Broth for the candidate method. This enrichment media formulation is

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less selective than the modified University of Vermont Medium used in the USDA reference

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method and may have contributed to the higher

observed proportion positive results level of

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recovery observed

during the evaluation.

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A second possible contribution

to the higherfor the higher observed proportion positive

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resultslevel of recovery was is

the length of the primary enrichment. Test portions evaluated by

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the 3M MDA 2 –

Listeria monocytogenes

method were incubated for a minimum of 28 hours in

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the primary enrichment, while the USDA reference method had a maximum primary enrichment

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time of 26 hours. No statistically significant difference was observed between the candidate

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method presumptive and confirmed results for this matrix.

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