ERP Micro December 2019

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

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C

95% CI 0.00, 0.43

X

POD R

95% CI 0.00, 0.43

d

e

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

Mexican Soft Cheese (25 g)

0.33 (0.20, 0.60) 2.41 (1.17, >10)

BMX 10425 4b

20

3

0.15

0.05, 0.36

5

0.25

0.11, 0.47

0.10

-0.34, 0.15

22 hours

5

4

0.80

0.38, 1.00

4

0.80

0.38, 1.00

0.00

-0.47, 0.47

Candidate

Reference

Matrix/Test Portion

MPN a / Test Portion

Strain

Time Point

N b

dPOD C f

95% CI g

x c

POD C

95% CI 0.00, 0.43

X

POD R

95% CI 0.00, 0.43

d

e

-

5

0

0.00

0

0.00

0.00

-0.43, 0.43

Mexican Soft Cheese (125 g)

0.71 (0.27, 0.73) 1.38 (0.72, 4.38)

BMX 10425 4b

20

5

0.25

0.11, 0.47

5

0.25

0.11, 0.47

0.00

-0.26, 0.26

24 hours

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) unless data are presented for both confirmation protocols as noted by the column header

Table 22: GENE-UP ™ LMO Assay, Presumptive vs. Confirmed h – POD Results (METHOD DEVELOPER) (1) Matrix/Test Portion Strain Time Point MPN a / Test Portion N b

Presumptive

Confirmed - Alternative

dPOD CP f

95% CI g

x c

POD CP d

95% CI 0.00, 0.43 0.43, 0.82

X

POD CC e

95% CI 0.00, 0.43 0.43, 0.82

-

5

0

0.00 0.65

0

0.00 0.65

0.00 0.00

-0.43, 0.43 -0.13, 0.13

0.37 (0.24, 0.80) 4.38 (2.35, 11.15)

Deli Ham (25 g)

22 hours

BMX 1 10432 1/2b

20

13

13

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Presumptive

Confirmed – Traditional

Matrix/Test Portion

Time Point

MPN a / Test Portion

Strain

N b

dPOD CP f

95% CI g

x c

POD CP d

95% CI 0.00, 0.43 0.43, 0.82

X

POD CC e

95% CI 0.00, 0.43 0.22, 0.61

-

5

0

0.00 0.65

0 8

0.00 0.40

0.00 0.25

-0.43, 0.43

0.37 (0.24, 0.80) 4.38 (2.35, 11.15)

Deli Ham (25 g)

22 hours

BMX 1 10432 ½b

20

13

0.02, 0.48

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43