274 / 1195
AOAC INTERNATIONAL
532
Qn = (2)
3.3
= 9.85 The predicted shelf life is thus at least 147 days X 9.85 = 1448
533
days or 3.97 years.
534
535
536
537
538
539
Table 4. Summary of lot to lot and stability studies
Time
Point (days) Lot Number
Storage
Temp (°C)
BAX ®
Salmonella
Positive
BAX ® Positive
Non-Target
Organisms
BAX ® Positive
Lysis Buffer Only
98
1144
4
37
10/10
10/10
0/6
0/6
0/2
0/2
98
1346
37
10/10
0/6
0/2
147
1241
4
37
10/10
10/10
0/6
0/6
0/2
0/2
540
Results and Discussion
– Table 4 shows 100% agreement among results for the three
541
lots, indicating no evidence of lot-to-lot performance differences. A shelf life of three
542
years has been assigned to this product and is supported by this data. Real-time
543
testing using kits stored at 4ºC is continuing and will be used to validate the shelf life
544
that the accelerated stability data supports.
545
546
18. RUGGEDNESS STUDY
547
548
Methodology
–The BAX® System was evaluated to determine whether it performs as
549
expected despite variations in operational parameters. Since the entire amplification
550
and detection phases are fully automated and not subject to user modification,
551
independent variables were selected from the enrichment and sample preparation
552
phases. Table 7 shows the seven variables, with high and low levels, believed to have
553
the largest potential for impact on performance.
554
555
Dupont BAX Salmonella PTM Report
PTM Certification No. 081201 (08/07/2012)
For Expert Review Panel Use Only
Do Not Distribute