464 / 596
Table 16: Lot-to-Lot/Stability Study Results
Expiration Date
Expiration Date
Expiration Date
Lot #: 012715
Lot #: 081914
Lot #: 050114
Sample #
Result
Sample #
Result
Sample #
Result
Listeria monocytogenes
ATCC
2
7644
Low Level
6/10
Low Level
6/10
Low Level
6/10
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
1
All samples were analyzed from a common lysate
2
ATCC- American Type Culture Collection
Table 17: Robustness Results
Robustness
1
Robustness
1
13 Minute Lysis
13 Minute Lysis
Sample #
18 µL
2
, 18 µL
3
18 µL
2
, 22 µL
3
Sample #
22 µL
2
, 18 µL
3
22 µL
2
, 22 µL
3
Listeria monocytogenes
ATCC
4
7644
Low Level
6/10
6/10
Low Level
7/10
7/10
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
0/5
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
0/5
Robustness
1
Robustness
1
17 Minute Lysis
17 Minute Lysis
Sample #
18 µL
2
, 18 µL
3
18 µL
2
, 22 µL
3
Sample #
22 µL
2
, 18 µL
3
22 µL
2
, 22 µL
3
Listeria monocytogenes
ATCC
4
7644
Low Level
6/10
6/10
Low Level
6/10
6/10
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
0/5
Un
-
inoculated
Target Organism
(
Enterococcus
faecalis
ATCC
29212)
0/5
0/5
1
All samples were analyzed from a common lysate
2
Volume of enrichment to lysis
3
Volume of lysis to assay
4
ATCC- American Type Culture Collection