AOAC ERP MICRO AUGUST 2018

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

Table 8: 3M ™ MDA 2 Listeriamonocytogenes Assay, Candidate vs. Reference – POD Results (INTERNAL STUDY) Matrix Strain Analysis N b 3M MDA2 USDA/FSIS MLG

MPN a / Test Portion

95% CI g

dPOD C f

Time Point

x c

d

e

POD C

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 0.23, 0.88 95% CI 0.00, 0.43 0.30, 0.70 0.23, 0.88

X

POD R

95% CI 0.00, 0.43 0.39, 0.78 0.57, 1.00 95% CI 0.00, 0.43 0.30, 0.70 0.57, 1.00 95% CI 0.00, 0.43 0.15, 0.60 0.57, 1.00 95% CI 0.00, 0.43 0.26, 0.66 0.38, 0.96

-

5

0

0.00 0.50 1.00

0

0.00 0.60 1.00

0.00 -0.10 0.00

-0.43, 0.43 -0.37, 0.19 -0.43, 0.43

Raw Chicken Leg Pieces (25 g)

L. monocytogenes Ad 668

0.91 (0.6, 1.39)

20

10

12

28 Hours

2.2

5

5

5

Analysis Time Point

3M MDA2

ISO 11290-1

MPN a / Test Portion

N b

95% CI g

dPOD C f

Matrix

Strain

x c

d

e

POD C

X

POD R

-

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 -0.34, 0.25 -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

Analysis Time Point

3M MDA2

FDA-BAM

MPN a / Test Portion

N b

95% CI g

dPOD C f

Matrix

Strain

x c

d

e

POD C

X

POD R

-

5

0

0.00 0.50 0.60

0 7 5

0.00 0.35 1.00

0.00 0.15 -0.40

-0.43, 0.43 -0.20, 0.47 -0.77, 0.12

Cold Smoked Salmon (25 g)

L. monocytogenes Ad 670

24 Hours

0.4 (0.18, 0.72)

20

10

2.7

5

3

Analysis Time Point

3M MDA2

ISO 11290-1

MPN a / Test Portion

N b

95% CI g

dPOD C f

Matrix

Strain

x c

d

e

POD C

X

POD R

-

5

0

0.00 0.50 0.60

0 9 4

0.00 0.45 0.80

0.00 0.05 -0.20

-0.43, 0.43 -0.27, 0.36 -0.60, 0.31

Cold Smoked Salmon (25 g)

L. monocytogenes Ad 670

24 Hours

0.4 (0.18, 0.72)

20

10

2.7

5

3

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

AOAC Research Institute Expert Review Panel Use Only