AOAC ERP MICRO AUGUST 2018

OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only

Table 12: 3M ™ MDA 2 Listeriamonocytogenes Assay, Presumptive vs. Confirmed – POD Results (INTERNAL STUDY)

Presumptive

Confirmed

Analysis Time Point

MPN a / Test Portion

N b

95% CI g

dPOD CP f

Matrix

Strain

POD CP d

x c

POD CC e

95% CI 0.00, 0.43 0.30, 0.70 0.57, 1.00 95% CI 0.00, 0.43 0.26, 0.66 0.57, 1.00 95% CI 0.00, 0.43 0.30, 0.70

X

95% CI 0.00, 0.43 0.30, 0.70 0.57, 1.00 95% CI 0.00, 0.43 0.30, 0.70 0.57, 1.00 95% CI 0.00, 0.43 0.30, 0.70

-

5

0

0.00 0.50 1.00

0

0.00 0.50 1.00

0.00 0.00 0.00

-0.43, 0.43 -0.28, 0.28 -0.43, 0.43

Raw Chicken Leg Pieces (25 g)

L. monocytogenes Ad 668

28 Hours

0.91 (0.6, 1.39)

20 10

10

2.2

5

5

5

Presumptive

Confirmed

Analysis Time Point

MPN a / Test Portion

N b

95% CI g

dPOD CP f

Matrix

Strain

POD CP d

x c

POD CC e

X

-

5

0 9 5

0.00 0.45 1.00

0

0.00 0.50 1.00

0.00 -0.05 0.00

-0.43, 0.43 -0.33, 0.24 -0.43, 0.43

Bagged Raw Spinach (25 g)

L. monocytogenes Ad 543

24 Hours

1.17 (0.74, 1.84)

20

10

2.9

5

5

Presumptive

Confirmed

Analysis Time Point

MPN a / Test Portion

N b

95% CI g

dPOD CP f

Matrix

Strain

POD CP d

x c

POD CC e

X

-

5

0

0.00 0.50

0

0.00 0.50

0.00 0.00

-0.43, 0.43 -0.28, 0.28

Cold Smoked Salmon (25 g)

L. monocytogenes Ad 670

0.4 (0.18, 0.72)

20 10

10

24 Hours

2.7

5

3

0.60

0.23, 0.88

3

0.60

0.23, 0.88

0.00

-0.46, 0.46

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

AOAC Research Institute Expert Review Panel Use Only