AOAC-RI ERP Micro June 2016
OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only
Table 15: 3M ™ MDA 2 - Listeria Assay, Presumptive vs. Confirmed – POD Results (INDEPENDENT STUDY)
Analysis Time Point
Presumptive
Confirmed
CFU a / Test Area
N b
95% CI g
dPOD CP f
Matrix
Strain
x c
d
POD CC e
POD CP
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
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
-
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 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
0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
-0.43, 0.43 -0.26, 0.26 -0.43, 0.43 -0.43, 0.43 -0.26, 0.26 -0.43, 0.43 -0.43, 0.43 -0.26, 0.26 -0.43, 0.43 -0.43, 0.43 -0.26, 0.26 -0.43, 0.43 -0.43, 0.43 -0.26, 0.26 -0.43, 0.43 -0.43, 0.43 -0.26, 0.26 -0.43, 0.43 95% CI g 95% CI g
L. monocytogenes ATCC 19118 & Enterococcus faecium ATCC 19434
20
42 & 530
24 Hours
Stainless Steel (225 mL)
5 5
400 & 4000
-
20
26 Hours
42 & 530
5
400 & 4000 CFU a / Test Area
Analysis Time Point
Presumptive
Confirmed
N b
dPOD CP f
Matrix
Strain
x c
d
POD CC e
POD CP
X
-
5
0
0
20
15
15
35
24 Hours
Sealed Concrete (100 mL)
5 5
5 0
5 0
360
L. monocytogenes ATCC 19117
-
20
15
15
26 Hours
35
5
5
5
360
Analysis Time Point
Presumptive
Confirmed
CFU a / Test Area
N b
dPOD CP f
Matrix
Strain
x c
d
POD CC e
POD CP
X
-
5
0
0
L. monocytogenes ATCC 51782 & Enterococcus faecalis ATCC 29212
20
15
15
64 &540
24 Hours
5 5
5 0
5 0
590 & 3600
Plastic (10 mL)
-
64 & 540 AOAC Research Institute Expert Review Panel Use Only 20 15 15 590 & 3600 5 5 5
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 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 statistically significant at the 5% level All matrixes tested in Table 13 used Demi Fraser (with FAC) brand Y.
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