AOAC-RI ERP Micro June 2016

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

Table 11: 3M ™ MDA 2 - Listeria Assay, Candidate vs. Reference – POD Results (INDEPENDENT STUDY) Matrix Strain Analysis N b 3M MDA2 Reference

CFU a / Test Area

95% CI g

dPOD C f

Time Point

x c

d

e

POD C

95% CI 0.00, 0.43 0.11, 0.47 0.57, 1.00 0.00, 0.43 0.11, 0.47 0.57, 1.00 95% CI 0.00, 0.43 0.53, 0.89 0.57, 1.00 0.00, 0.43 0.53, 0.89 0.57, 1.00 95% CI 0.00, 0.43 0.53, 0.89 0.57, 1.00 0.00, 0.43 0.53, 0.89 0.57, 1.00

X

POD R

95% CI 0.00, 0.43 0.22, 0.61 0.57, 1.00 0.00, 0.43 0.22, 0.61 0.57, 1.00 95% CI 0.00, 0.43 0.34, 0.74 0.57, 1.00 0.00, 0.43 0.34, 0.74 0.57, 1.00 95% CI 0.00, 0.43 0.34, 0.74 0.57, 1.00 0.00, 0.43 0.22, 0.74 0.57, 1.00

-

5

0 5 5 0 5 5

0.00 0.25 1.00 0.00 0.25 1.00 0.00 0.75 1.00 0.00 0.75 1.00 0.00 0.75 1.00 0.00 0.75 1.00

0 8 5 0 8 5

0.00 0.40 1.00 0.00 0.40 1.00 0.00 0.55 1.00 0.00 0.55 1.00 0.00 0.55 1.00 0.00 0.55 1.00

0.00 -0.10 0.00 0.00 -0.10 0.00 0.00 0.20 0.00 0.00 0.20 0.00 0.00 0.20 0.00 0.00 0.20 0.00

-0.43, 0.43 -0.40, 0.13 -0.43, 0.43 -0.43, 0.43 -0.40, 0.13 -0.43, 0.43 -0.43, 0.43 -0.09, 0.45 -0.43, 0.43 -0.43, 0.43 -0.09, 0.45 -0.43, 0.43 -0.43, 0.43 -0.09, 0.45 -0.43, 0.43 -0.43, 0.43 -0.09, 0.45 -0.43, 0.43 95% CI g 95% CI g

L. monocytogenes ATCC 19118 & Enterococcus faecium ATCC 19434

20

24 Hours

42 & 530

Stainless Steel (225 mL)

5 5

400 & 4000

-

26 Hours

20

42 & 530

5

400 & 4000 CFU a / Test Area

Analysis Time Point

3M MDA2

Reference

N b

dPOD C f

Matrix

Strain

x c

d

e

POD C

X

POD R

-

5

0

0

20

15

11

35

24 Hours

Sealed Concrete (100 mL)

5 5

5 0

5 0

360

L. monocytogenes ATCC 19117

-

26 Hours

20

15

11

35

5

5

5

360

Analysis Time Point

3M MDA2

Reference

CFU a / Test Area

N b

dPOD C f

Matrix

Strain

x c

d

e

POD C

X

POD R

-

5

0

0

L. monocytogenes ATCC 51782 & Enterococcus faecalis ATCC 29212

24 Hours

20

15

11

64 &540

590 & 3600 AOAC Research Institute Expert Review Panel Use Only 5 5 5 0 5 0 - 64 & 540 20 15 11 590 & 3600 5 5 5

Plastic (10 mL)

26 Hours

a CFU/Test Area = Results of the CFU/Test area were determined by plating the inoculum for each matrix in triplicate 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 All matrixes tested in Table 11 used Demi Fraser brand Y.