ERP Micro December 2019

bioMérieux, Inc. GENEUP ® Listeria monocytogenes 2 (LMO 2) AOAC ® Certification Number 121804

a MPN = Most Probable Number is calculated using the LCF MPN calculator provided by AOAC RI, with 95% confidence interval b N = Number of test portions c x = Number of positive test portions

d POD CP = Candidate method presumptive positive outcomes divided by the total number of trials e POD CC = Candidate method confirmed positive outcomes divided by the total number of trials

f dPOD CP = Difference between the candidate method presumptive result and candidate method confirmed result POD values g 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level h Confirmed results were identical for the Alternative confirmation protocol (ALOA) and the Traditional confirmation protocol (MOX) unless data are presented for both confirmation protocols as noted by the column header

Table 23: GENE-UP ™ Listeria monocytogenes Assay, Candidate h vs. Reference – POD Results (INDEPENDENT) (1) Matrix/Test Portion Strain Time Point MPN a / Test Portion N b

Candidate

Reference

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

Listeria monocytogenes CWD 1626

0.45 (0.22, 0.78) 4.38 (1.72, 11.15)

Deli Ham (25 g)

20

10

0.50

0.30, 0.70

7

0.35

0.18, 0.57

0.15

-0.15, 0.41

22 Hour

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

Smoked Salmon (25 g)

Listeria monocytogenes ATCC 15313

0.35 (0.17, 0.62) 3.01 (1.31, 6.89)

20

8

0.40

0.22, 0.61

5

0.25

0.11, 0.47

0.15

-0.13, 0.40

22 Hour

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C d

95% CI 0.00, 0.43

X

POD R e

95% CI 0.00, 0.43

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

Mexican Soft Cheese (125 g)

Listeria monocytogenes ATCC 51778

0.44 (0.21, 0.76) 3.01 (1.31, 6.89)

20

8

0.40

0.22, 0.61

6

0.30

0.14, 0.52

0.10

-0.18, 0.36

24 Hour

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

a MPN = Most Probable Number is calculated using the LCF MPN calculator provided by AOAC RI, with 95% confidence interval b N = Number of test portions c x = Number of positive test portions

d POD C = Candidate method confirmed positive outcomes divided by the total number of trials e POD R = Reference method confirmed positive outcomes divided by the total number of trials

f dPOD C = Difference between the confirmed candidate method result and reference method confirmed result POD values g 95% CI = If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level h Candidate confirmed results used for these analysis were identical for the Alternative confirmation protocol (ALOA) and the Traditional confirmation protocol (MOX)