AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

Table 8: 3M ™ MDA 2 - Listeria 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 28 Hours

x c

d

e

POD C

95% CI 0.00, 0.43 0.08, 0.42 0.23, 0.88 95% CI 0.00, 0.43 0.08, 0.42 0.12, 0.77 95% CI 0.00, 0.43 0.15, 0.52 0.23, 0.88 95% CI 0.00, 0.43 0.15, 0.52 0.23, 0.88 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

X

POD R

95% CI 0.00, 0.43 0.11, 0.47 0.04, 0.62 95% CI 0.00, 0.43 0.11, 0.47 0.38, 0.96 95% CI 0.00, 0.43 0.05, 0.36 0.38, 0.96 95% CI 0.00, 0.43 0.26, 0.66 0.38, 0.96 95% CI 0.00, 0.43 0.18, 0.57 0.38, 0.96 95% CI 0.00, 0.43 0.22, 0.61 0.38, 0.96

-

5

0 4 3

0.00 0.20 0.60

0 5 1

0.00 0.25 0.20

0.00 -0.05 0.40

-0.43, 0.43 -0.30, 0.21 -0.16, 0.73

Raw Chicken Leg Pieces h (25 g)

L. ivanovii Ad 1291

0.31 (0.14, 0.57)

20

0.5

5

Analysis Time Point

3M MDA2

USDA/FSIS MLG

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 4 2

0.00 0.20 0.40

0 5 4

0.00 0.25 0.80

0.00 -0.05 -0.40

-0.43, 0.43 -0.30, 0.21 -0.73, 0.16

Raw Chicken Fillet i (25 g)

L. ivanovii Ad 1291

28Hours

0.3 (0.10, 0.5)

20

0.5

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 6 3

0.00 0.30 0.60

0 3 4

0.00 0.15 0.80

0.00 0.15 -0.20

-0.43, 0.43 -0.11, 0.39 -0.60, 0.31

Bagged Raw Spinach h (25 g)

L. seeligeri Ad 1754

24 Hours

0.26 (0.10, 0.47)

20

1.7

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 6 3

0.00 0.30 0.60

0 9 4

0.00 0.45 0.80

0.00 -0.15 -0.20

-0.43, 0.43 -0.41, 0.14 -0.60, 0.31

Bagged Raw Spinach h (25 g)

L. seeligeri Ad 1754

24 Hours

0.26 (0.10, 0.47)

20

1.7

5

Analysis Time Point

3M MDA2

FDA-BAM

MPN a / Test Portion

N b

95% CI g

dPOD C f

Matrix

Strain

x c AOAC Research Institute Expert Review Panel Use Only POD C d X POD R e - 5 0 0.00 0.50 1.00 0 7 4 0.00 0.35 0.80 0.00 0.15 0.20 0.27 (0.10, 0.49) 20 10 1.7 5 5 MPN a / Test Portion N b 3M MDA2 ISO 11290-1 x c POD C d X POD R e

-0.43, 0.43 -0.15, 0.41 -0.26, 0.62

Cold Smoked Salmon h (25 g)

L. innocua Ad 1674

24 Hours

Analysis Time Point

95% CI g

dPOD C f

Matrix

Strain

-

5

0

0.00 0.50 1.00

0 8 4

0.00 0.40 0.80

0.00 0.10 0.20

-0.43, 0.43 -0.19, 0.37 -0.26, 0.62

Cold Smoked Salmon h (25 g)

L. innocua Ad 1674

24 Hours

0.27 (0.10, 0.49)

20

10

1.7

5

5