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Table C: Robustness Parameter Variations
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3
Treatment
Combination
Lysis Time
Volume
(Enrichment to
lysis)
Volume
(Lysis to assay)
# of Replicates
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
4
5
Results
6
7
Treatment combinations 1 and 2
8
9
For the 13 minute lysis and the 18 µL aliquot of enrichment to lysis robustness analysis of the
10
MDA 2 -
Listeria
assay, there were 6 presumptive positives out of 10 replicates at the low level
11
inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out
12
of 5 replicates. All 5 uninoculated control test portions were negative.
13
14
For the low inoculation level, a POD value of 0.60 was obtained with a 95% confidence interval
15
of (0.31, 0.83). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%
16
confidence interval of (0.00,0.43).
17
18
Treatment combinations 3 and 4
19
20
For the 13 minute lysis and the 22 µL aliquot of enrichment to lysis robustness analysis of the
21
MDA 2 -
Listeria
assay, there were 7 presumptive positives out of 10 replicates at the low level
22
inoculation. For the 5 uninoculated control test portions, there were 0 presumptive positives out
23
of five replicates.
24
25
For the low invocation level, a POD value of 0.70 was obtained with a 95% confidence interval
26
of (0.40, 0.89). All 5 non-target test portions were negative with a POD value of 0.00 with a 95%
27
confidence interval of (0.00, 0.43).
28
29
Treatment combinations 5, 6, 7 and 8
30
31
For both 17 minutes lysis procedures robustness analysis of the MDA 2 -
Listeria
assay, there
32
were 6 presumptive positives out of 10 replicates at the low level inoculation. For the 5
33
uninoculated control test portions, there were 0 presumptive positives out of 5 replicates. See
34
Table 17 for robustness results.
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