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following the reference method.Detailed results of the POD analyses are presented in Tables 11

1

and 15.

2

3

All five uninoculated control test portions were negative by both the MDA2 -

Listeria

4

monocytogenes

assay and the corresponding reference method for each matrix above.

5

6

7

Product Consistency (Lot-to-Lot) and Stability Studies

8

9

Methodology

10

Three lots of MDA2 –

Listeriamonocytogenes

test kits, 1 newly manufactured, 1 at the middle of

11

its expiration, and 1 at or slightly beyond expiration was analyzed to determine the stability of

12

the assay. For the MDA2 –

Listeriamonocytogenes

test kit, one

Listeria monocytogenes

ATCC

13

7644 isolate was analyzed at a fractional positive level (2-8 positives), and testing 10 replicates.

14

One non-

Listeriamonocytogenes

isolate,

Enterococcus faecalis

ATCC 29212, was analyzed at the

15

growth level achieved in a non-selective broth, testing 5 replicates.

16

17

Results

18

For the lot-to-lot/stability evaluation of the MDA2 -

Listeria monocytogenes

assay, there were 6

19

presumptive positives out of 10 replicates for all three lots at the low inoculation level. For the 5

20

uninoculated control test portions, there were 0 presumptive positives out of 5 replicates for all

21

three lots.The five control test portions were negative. See Tables 16 for lot-to-lot/stability

22

results.

23

24

Robustness Study

25

26

Methodology

27

The robustness evaluated the ability of the method to remain unaffected by minor variations in

28

method parameters that might be expected to occur when the method is performed by an end

29

user. Three different parameters were evaluated, which are presented in Table 17.For each

30

parameter, one

Listeria monocytogenes

ATCC 7644isolate was analyzed at a fractional positive

31

level (2-8 positives), testing 10 replicates. One non-

Listeriamonocytogenes

isolate,

Enterococcus

32

faecalis

ATCC 29212, was analyzed at the growth level achieved in a non-selective broth, testing

33

5 replicates.

34

35

Results

36

37

For the robustness analysis of the MDA2 -

Listeria monocytogenes

assay, there were 6

38

presumptive positives out of 10 replicates for each variation evaluated. For the 5 control test

39

portions, there were 0 presumptive positives out of 5 replicates. See Table 17 for robustness

40

results.

41

42

Independent Laboratory Observations

43

44

The results of this study demonstrate the ability of the MDA2

Listeria monocytogenes

to detect

45

the presence of

Listeria monocytogenes

in various food matrices and select environmental

46

AOAC Research Institute

Expert Review Panel Use Only

OMAMAN-30 D/ PTM Validation Report 081501

OMA ERP - June 2016

ERP Use Only