ERP Micro December 2019

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

Table 24: GENE-UP ™ Listeria monocytogenes Assay, Presumptive vs. Confirmed h – POD Results (INDEPENDENT) (1)

Presumptive

Confirmed

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

X

POD CC 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)

22 Hour

20

10

0.50

0.30, 0.70

10

0.50

0.30, 0.70

0.00

-0.28, 0.28

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Presumptive

Confirmed

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 0.22, 0.61

X

POD CC e

95% CI 0.00, 0.43 0.22, 0.61

-

5

0 8

0.00 0.40

0 8

0.00 0.40

0.00 0.00

-0.43, 0.43 -0.28, 0.28

Listeria monocytogenes ATCC 15313

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

Smoked Salmon (25 g)

22 Hour

20

5

5

1.00

0.57, 1.00

5

1.00

0.57, 1.00

0.00

-0.43, 0.43

Presumptive

Confirmed

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

X

POD CC 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)

24 Hour

20

8

0.40

0.22, 0.61

8

0.40

0.22, 0.61

0.00

-0.28, 0.28

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 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)