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16

significant difference between the two methods.

A dLPOD

CP

value of 0.01 with 95% confidence

1

intervals of (-0.03, 0.05) was obtained between presumptive and confirmed results indicating

the

2

difference between presumptive and confirmed results was not statistically significant at the 0.05

3

probability

level.no

statistically significant difference between the presumptive and confirmed

4

results.

5

6

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

7

1D.

8

9

Discussion

10

11

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

12

performance of the 3M MDA 2-

Listeria

method. During the evaluation of the raw chicken breast

13

fillet, Laboratory 2 isolated

Listeria innocua

from an un-inoculated control sample. Since the

14

organism recovered was different from the inoculating organism,

Listeria monocytogenes,

no

15

just cause for removal of the data was determined and the data was included in the manuscript.

16

For the raw chicken breast fillet, Laboratory 10 reported isolating

Listeria monocytogenes

from

17

two un-inoculated control samples. The isolates were sent for further identification and it was

18

determined that they were the same strain as the inoculating organism, indicating that cross

19

contamination of the sample occurred. Due to the fact that cross contamination occurred, just

20

cause removal of the data was established and the data generated by Laboratory 10 was therefore

21

not included in the statistical analysis.

22

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

23

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

the difference

24

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

25

probability level. And that the difference between presumptive and confirmed candidate method

26

was not statistically significant at the 0.05 probability level.thatno statistically significant

27

difference between the candidate method and the reference method or between the presumptive

28

and confirmed results of the candidate method was obtained.

For raw chicken breast fillet, a

29

statistically significant difference was observed between the reference and the alternative

30

method.

The dLPOD being significantly greater than zero showed an observed higher proportion

31

of positive results by the candidate method than the reference method.The dLPOD data indicated

32

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

33

method.

One possible contribution

for the higher observed proportion positive resultsto the

34

higher level of recovery

observed with the 3M MDA 2 –

Listeria

method was the use of Demi-

35

Fraser Broth for the candidate method. This enrichment media formulation is less selective than

36

the modified University of Vermont Medium used in the USDA reference method and may have

37

contributed to the higher level of recovery observed during the evaluation. A second possible

38

contribution

tfor the higher observed proportion positive resultso the higher level of recovery

39

was the length of the primary enrichment. Test portions evaluated by the 3M MDA 2 –

Listeria

40

method were incubated for a minimum of 28 hours in the primary enrichment, while the USDA

41

reference method had a maximum primary enrichment time of 26 hours. No statistically

42