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February 20, 2013

23

1

For the low level inoculum, a dPOD

C

value of 0.00 with 95% confidence intervals of (-0.27, 0.27) was

2

obtained between the reference and candidate method samples confirmed following both the

3

traditional and alternative confirmation procedures at both the 18 hour and 24 hour primary

4

enrichment time points. The confidence intervals obtained for dPOD

C

indicated no significant

5

difference between the two methods. A dPOD

CP

value of 0.00 with 95% confidence intervals of (-0.27,

6

0.27) was obtained between presumptive and confirmed results using either the traditional and

7

alternative confirmation procedures for both the 18 and 24 hour primary enrichment time points. The

8

confidence intervals obtained for dPOD

CP

indicated no significant difference between the presumptive

9

and confirmed results.

10

11

INDEPENDENT LABORATORY STUDY

12

The independent laboratory study was conducted at Aegis Food Testing Laboratories in North Sioux

13

City, SD. The study was conducted according to the methods described above for raw ground chicken

14

and pasteurized liquid whole eggs.

15

16

Raw Ground Chicken

17

All uninoculated control samples of ground chicken were confirmed negative for

Salmonella

. The samples

18

were inoculated

S. enterica

subsp. Enteritidis

(NCTC 5717),

with an estimated 0.031 cells/g as determined

19

by MPN. The 3M Petrifilm SALXSystem detected 13 suspect colonies of which12 samples were presumptive

20

when the confirmation disk was added. All 12 of the presumptive samples confirmed as positive by the

21

USDA/FSIS MLG 4.05 reference method. There were 11 ground chicken samples that were determined to

22

be positive by the reference method. When comparing the number of samples determined to be positive

23

by the 3M Petrifilm SALX System to that of the reference method, there was no statistical difference in the

24

results obtained (χ

2

<3.8, p<0.05). The number of samples that were presumptive positive from the 3M

25

Petrifilm SALX System was compared to the number confirmed as positive using probability of detection

26

(POD) and difference in probability (dPODcp). The 95% confidence interval for the dPOD for the 3M

27

Petrifilm SALX System presumptive positives compared to the confirmed positive contains zero. Therefore,

28

there was no significant difference in the results at the 5% level. The number of samples that were

29

confirmed positive from the 3M Petrifilm SALX System was compared to the number confirmed as positive

30

by the reference method using probability of detection (POD) and difference in probability (dPODc). The

31

95% confidence interval for the dPOD for the 3M Petrifilm SALX System confirmed positives compared to

32

the reference method confirmed positive contains zero. Therefore, there was no significant difference in

33

the results at the 5% level.

34

35

Pasteurized Liquid Whole Eggs

36

All uninoculated control samples of pasteurized liquid eggs were confirmed negative for

Salmonella

.

37

The samples were inoculated with an estimated 0.008 cells/g of

S. enterica

subsp. Enteritidis (ATCC

38

13076, heat stressed)

as determined by MPN. The 3M Salmonella Petrifilm System detected 7 suspect

39

colonies of which 7 samples were presumptive when the confirmation disk was added. All 7 of the

40

presumptive samples confirmed as positive by the USDA/FSIS MLG 4.05 reference method. There were

41

8 pasteurized liquid eggs samples that were determined to be positive by the reference method. When

42

comparing the number of samples determined to be positive by the 3M Petrifilm SALX System to that

43

of the reference method, there was no statistical difference in the results obtained (χ

2

<3.8, p<0.05).

44

The number of samples that were presumptive positive from the 3M Petrifilm SALX System was

45

compared to the number confirmed as positive using probability of detection (POD) and difference in

46

probability (dPODcp). The 95% confidence interval for the dPOD for the 3M Petrifilm SALX System

47