481 / 1195
Table 4. Ruggedness Results for the Evaluation of Varied Enriched Sample Volumes, Lysis Volumes and Lysis
1
Times in the 3M Molecular Detection Assay
Salmonella
2
3
Isolate
# of
Samples
Enriched Sample Volume, µL
& Lysis Volume, µL*
Lysis Time, min
18, 18
20, 20
22, 22
13
15
17
S. Typhimurium
5
5
5
5
5
5
5
S. Enteritidis
5
5
5
5
5
5
5
C. freundii
5
0
0
0
0
0
0
BPW ISO
5
0
0
0
0
0
0
*Perturbations were performed at the same time for these two parameters
4
5
6
7
8
Table 5. Lot to lot/stability Results
9
10
Point in shelf life - # positive
Strain
# of
samples
Newly manufactured
3 months
Lot: 43-7800-1767-9
Middle of shelf life
7 months
Lot: 42-0023-3277-5
Near end of shelf life
13 months
Lot: 42-0023-3791-5
S. Enteritidis
8
8
8
8
S. Typhimurium
8
8
8
8
C. freundii
8
0
0
0
23