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
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