AOAC ERP MICRO AUGUST 2018
OMAMAN-30 D/ PTM Validation Report 081501 OMA ERP - June 2016 ERP Use Only
Table 11: 3M ™ MDA 2 Listeriamonocytogenes 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 0.39, 0.78 0.57, 1.00 0.00, 0.43 0.39, 0.78 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 0.30, 0.70 0.57, 1.00 0.00, 0.43 0.30, 0.70 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 0.60 1.00 0.00 0.60 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 0.50 1.00 0.00 0.50 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 0.10 0.00 0.00 0.10 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 -0.19, 0.37 -0.43, 0.43 -0.43, 0.43 -0.19, 0.37 -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
12
10
42& 540
5 5
5 0
5 0
590 & 3600
Plastic (10 mL)
- AOAC Research Institute Expert Review Panel Use Only 42& 540 20 12 10 590 & 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 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
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