176 / 596
Combination
(Enrichment to
lysis)
(Lysis to assay)
1
13 minutes
18 µL
18 µL
10
2
13 minutes
18 µL
22 µL
10
3
13 minutes
22 µL
18 µL
10
4
13 minutes
22 µL
22 µL
10
5
17 minutes
18 µL
18 µL
10
6
17 minutes
18 µL
22 µL
10
7
17 minutes
22 µL
18 µL
10
8
17 minutes
22 µL
22 µL
10
1
2
Results
3
4
Treatment combinations 1 and 2
5
6
For the 13 minute lysis and the 18 µL aliquot of enrichment to lysis robustness analysis of the
7
MDA 2 -
Listeria
assay, there were 6 presumptive positives out of 10 replicates at the low level
8
inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out
9
of 5 replicates. All 5 uninoculated control test portions were negative.
10
11
For the low inoculation level, a POD value of 0.60 was obtained with a 95% confidence interval
12
of (0.31, 0.83). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%
13
confidence interval of (0.00,0.43).
14
15
Treatment combinations 3 and 4
16
17
For the 13 minute lysis and the 22 µL aliquot of enrichment to lysis robustness analysis of the
18
MDA 2 -
Listeria
assay, there were 7 presumptive positives out of 10 replicates at the low level
19
inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out
20
of five replicates.
21
22
For the low invocation level, a POD value of 0.70 was obtained with a 95% confidence interval
23
of (0.40, 0.89). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%
24
confidence interval of (0.00, 0.43).
25
26
Treatment combinations 5, 6, 7 and 8
27
28
For both 17 minutes lysis procedures robustness analysis of the MDA 2 -
Listeria
assay, there
29
were 6 presumptive positives out of 10 replicates at the low level inoculation. For the 5
30
uninoculated control test portions, there were 0 presumptive positives out of 5 replicates. See
31
Table 17 for robustness results.
32
33
For the low invocation level, a POD value of 0.50 was obtained with a 95% confidence interval
34
of (0.24, 0.76). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%
35
confidence interval of (0.00, 0.43).
36
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29 D/ PTM Validation Report 111501
OMA ERP - June 2016
ERP Use Only