245 / 1195
AOAC INTERNATIONAL
421
Table 5. Exclusivity Results (con’t)
Sample ID (DD) ATCC Number
Sample strain name
Source
Result
13147
Providencia rettgeri
NEG
13148
Pseudomonas aeruginosa
NEG
577
17588
Pseudomonas stutzeri
human clinical
NEG
610
13565
Staphylococcus aureus
ham
NEG
849
21073
Raoultella
sp.
NEG
850
33821
Escherichia vulneris
NEG
2416
Serratia liquefaciens
NEG
2614
15947
Edwardsiella tarda
human feces
NEG
2901
Bacillus cereus
NEG
3981
29212
Enterococcus faecalis
urine
NEG
4169
Staphylococcus aureus
NEG
6523
Klebsiella oxytoca
NEG
6719
Escherichia hermannii
NEG
6832
Listeria monocytogenes
NEG
7083
Serratia marcescens
NEG
7088
Enterobacter agglomerans
NEG
7344
Lactobacillus acidophillus
NEG
13142
25834
Morganella morganii
human clinical
NEG
13147
29944
Providencia rettgeri
NEG
13148
27853
Pseudomonas aeruginosa
human clinical
NEG
3735
Staphylococcus epidermidis
NEG
422
423
424
16. CONCLUSION
425
426
The results of these studies demonstrate that an eight-cycle increase in the processing
427
time of the BAX® System Real-Time PCR Assay for
Salmonella
does not affect the
428
previously certified method, except to improve the sensitivity for low-level positive samples
429
around the limit of detection. This was demonstrated by showing no change in the results
430
for a variety of matrices spiked at a fractional level, through inclusivity and exclusivity, and
431
through documentation of fluorescent probe performance during the additional cycles for
432
samples that contain and those that do not contain
Salmonella
. It is recommended that the
433
modification to PTM #081201 be approved.
434
435
436
Dupont BAX Salmonella PTM Report
Modification Approved 2012 / PTM Certification No. 081201
For Expert Review Panel Use Only
Do Not Distribute