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For treatment combination 9, there were 3 presumptive positives out 10 replicates
for the variations evaluated. For the 5 uninoculated test portions, there were 0
presumptive positives out of 5 replicates.
For the low inoculation level, a POD value of 0.30 was obtained with a 95%
confidence interval of (0.11, 0.60). All 5 uninoculated test portions were negative
with a POD value of 0.00 with a 95% confidence interval of (0.00, 0.43).
Detailed results for the robustness tests are presented in Tables 21and 22ofthe
Appendix.
Product Consistency (Lot to Lot) and Stability Evaluation
Results Lot to lot consistency study
Primer probe: Master Mix lot variation
mericonE. coli O157 Screen Plus Pathogen Detection Assay
Each Pathogen detection assay was evaluated for detection consistency with each of the
probes in the multiplex mixture (
stx1/stx2; eae,
and O157
Figure1.
mericon
E. coliO157 Screen Plus
0
5
10
15
20
25
30
35
40
E.coli
O157:H7
E.coli O157 E.coli
O26:H-
E.coli
O111:H-
Citrobacter
freundii
Ct
Bacterial Strain
mericon
E. coli O157 Screen Plus: stx1/stx2
PP1/MM1
PP2/MM1
PP3/MM1
PP1/MM2
PP2/MM2
PP3/MM2
PP1/MM3
PP2/MM3
PP3/MM3
OMAMAN-36 E/ AOAC PTM Report
ERP Use Only
January 2017
AOAC Research Institute
Expert Review Panel Use Only