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0.01 (-0.10, 0.13) was obtained between presumptive and confirmed VIDAS LMX results for

1

both confirmation procedures. The confidence intervals obtained for dLPOD

CP

indicated no

2

significant difference between the presumptive and confirmed results.

3

For the high level inoculum, a dLPOD

C

value of 0.02 (-0.01, 0.06) was obtained between the

4

AOAC 993.12 method and the VIDAS LMX method. The confidence intervals obtained for

5

dLPOD

C

indicated no significant difference between the two methods. A dLPOD

CP

of

6

0.00 (-0.02, 0.02) was obtained between presumptive and confirmed VIDAS LMX results. The

7

confidence intervals obtained for dLPOD

CP

indicated no significant difference between the

8

presumptive and confirmed results. Results of the POD statistical analysis are presented in Table

9

2013.1A below, and Table 2013.2A-2Band Figures 1A-1B of the Appendix.

10

11

12

Queso Fresco (125 gram Test Portions)

13

14

Queso fresco test portions were inoculated at a low and high level and analyzed (Table 4) for the

15

detection of

Listeriamonocytogenes

. Un-inoculated controls were included in each sample set.

16

Fourteen laboratories participated in the analysis of this matrix and the results of 12 laboratories

17

were included in the statistical analysis. Laboratory 2 did not report any data for this matrix.

18

Laboratory 11 reported 10reference method test portions (including

19

5 un-inoculated control replicates) that produced non-

Listeria monocytogenes

profiles, with 5 of

20

the test portions producing questionable API profiles of

L. grayi

. Colonies on these plates

21

contained one or more of the following biochemical reactions not typically associated with

L.

22

monocytogenes

: Gram-negative,non-beta-hemolytic and catalase negative.Based on the

23

preliminary biochemical tests conducted the test portions should not have been carried through

24

for final biochemical identification on API

Listeria

strips which resulted in the misidentification

25

of the test portion as

Listeria

spp. The selective agar plates for these test portions were sent to the

26

coordinating laboratory for further examination. The coordinating laboratory verified the

27

supplementary results (Gram stain, hemolysis and catalase reaction) reported by the participating

28

laboratory and were not able to identify any

Listeria

species. The results from this laboratory

29

were excluded from statistical analysis. The MPN levels obtained for this test portion, with 95%

30

confidence intervals, were 0.59 CFU/test portion (0.46, 0.74) for the low level and 5.41 CFU/test

31

portion (3.53, 8.30) for the high level. For VIDAS LMX test portions, no differences were

32

observed between confirmation of samples using the proprietary chromogenic ALOA and the

33

reference method agar.

34

For the high level, 144 out of 144 test portions were reported as positive by the VIDAS LMX

35

method with all test portions confirming positive. For the low level, 70 out of 144 test portions

36

were reported as positive by the VIDAS LMX method with all 70 test portions confirming

37

positive. For the un-inoculated controls, 0 out of 144 samples produced a presumptive positive

38

result by the VIDAS LMX method and nosamples confirmed positive. For test portions

39

analyzed by the AOAC OMA 993.12 method, 144 out of 144 high inoculum and 69 out of 144

40

low inoculum test portions confirmed positive. For the un-inoculated controls, 0 out of 144 test

41

portions confirmed positive.

42

For the low level inoculum, dLPOD

C

values of 0.01 (-0.10, 0.13) were obtained between the

43

AOAC OMA 993.12 method and the VIDAS LMX method. The confidence intervals obtained

44

for dLPOD

C

indicated no significant difference between the two methods. dLPOD

CP

values of

45

0.00 (-0.12, 0.12) were obtained between presumptive and confirmed VIDAS LMX results. The

46

confidence intervals obtained for dLPOD

CP

indicated no significant difference between the

47

presumptive and confirmed results using either confirmation process.

48

11