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procedure. There were 3 observed positives for the reference method. For the high inoculation

1

level, there were 3 presumptive positives and 3 confirmed positives following the FDA/BAM

2

Chapter 10 reference method confirmation procedure. There were 4 confirmed positives

3

following the reference method. Detailed results of the POD analyses are presented in Tables 8

4

and 12. This matrix analysis was conducted using Demi Fraser with FAC brand X.

5

6

7

Compared to ISO 11290-1/A1

8

For the low inoculation level of the MDA 2 -

Listeria

assay, there were 6 presumptive positives

9

and 6 confirmed positives following the ISO 11290-1/A1 reference method confirmation

10

procedure. There were 9 observed positives for the reference method. For the high inoculation

11

level, there were 3 presumptive positives and 3 confirmed positives following the ISO 11290-

12

1/A1 reference method confirmation procedure. There were 4 confirmed positives following the

13

reference method. Detailed results of the POD analyses are presented in Tables 8 and 12

14

This matrix analysis was conducted using Demi Fraser with FAC brand X.

15

16

Cold smoked salmon

17

18

Compared to FDA-BAM

19

For the low inoculation level of the MDA 2 -

Listeria

assay, there were 10 presumptive positives

20

and 10 confirmed positives following the FDA/BAM Chapter 10 reference method confirmation

21

procedure. There were 7 observed positives for the reference method. For the high inoculation

22

level, there were 5 presumptive positives and 5 confirmed positives following the FDA/BAM

23

Chapter 10 reference method confirmation procedure. There were 4 confirmed positives

24

following the reference method. Detailed results of the POD analyses are presented in Tables 8

25

and 12. This matrix analysis was conducted using Demi Fraser with FAC brand X.

26

27

28

29

Compared to ISO 11290-1/A1

30

For the low inoculation level of the MDA 2 -

Listeria

assay, there were 10 presumptive positives

31

and 10 confirmed positives following the ISO 11290-1/A1 reference method confirmation

32

procedure. There were 8 observed positives for the reference method. For the high inoculation

33

level, there were 5 presumptive positives and 5 confirmed positives following the ISO 11290-

34

1/A1 reference method confirmation procedure. There were 4 confirmed positives following the

35

reference method. Detailed results of the POD analyses are presented in Tables 8 and 12.

36

This matrix analysis was conducted using Demi Fraser with FAC brand X.

37

38

39

40

Independent Study using Demi Fraser with FAC brand Y.

41

42

Deli turkey (125 g)

43

44

For the low inoculation level of the MDA 2 -

Listeria

assay, there were 8 presumptive positives

45

and 8 confirmed positives following the USDA/FSIS MLG 8.09 reference method confirmation

46

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-29 D/ PTM Validation Report 111501

OMA ERP - June 2016

ERP Use Only