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OFFICIAL METHODS
SM
EXPERT REVIEW PANEL
OMAMAN-07 :EVALUATION OF THE ANSR® FOR SALMONELLA ASSAY FOR IDENTIFICATION OF
SALMONELLA
SPP. FROM COLONY
PICKS FROM SELECTIVE/DIFFERENTIAL AGAR MEDIA: COLLABORATIVE STUDY
Are there any concerns regarding the safety of the method
(if necessary, refer to the review from the Safety Advisor)
?
1.
Expert Reviewer 1
No concerns
2.
Expert Reviewer 2
No.
3.
Expert Reviewer 3
No
4.
Expert Reviewer 4
No
5.
Expert Reviewer 5
No
6.
Expert Reviewer 6
No
Are there any concerns regarding the data manipulation, data tables or statistical analyses
(if necessary, refer to the review
from the Statistics Advisor)
?
1.
Expert Reviewer 1
I will comment on this section after receiving the review from the Statistics Advisor.
Specifically, I will take into consideration what the Stats Advisor has commented on as
relates to rationale for exclusion of data from the reported values in the Discussion
section on percent accuracy of inclusivity and exclusivity.
2.
Expert Reviewer 2
No.
3.
Expert Reviewer 3
No
4.
Expert Reviewer 4
No
5.
Expert Reviewer 5
No
6.
Expert Reviewer 6
No
Comments:
1.
Expert Reviewer 1:
1. For a collaborative study, the source / origin of the strains must be reported. All strains
used were ATCC, most were of an unknown origin. Would recommend in future studies that strains originating in
food should be selected if available. 2. In Appendix A (pre-collaborative study), section on results and discussion,
paragraph 1, last sentence should be removed. If one excludes results from strains that don't give the expected
result (ie, the False Negative on a strain of salmonella in the inclusivity study), accuracy would always be 100%. 3.
There is a relatively high level of false positive results on this confirmation method (perhaps due to DNA
contamination where there is no viable cell present). For a confirmation method, I would expect close to 100%
accuracy (vs. a screening method where false positives are less of a concern as confirmation procedures follow).
Should consideration be given to requiring a secondary confirmation step when this confirmation method is used,
at least if the test result is positive (e.g., poly-O seroytping). For consideration, negatives could be considered
final, while a positive PCR would be confirmed by a secondary test.
2.
Expert Reviewer 2:
None.
3.
Expert Reviewer 3:
1. Biosafety level 2 measures are not mentioned in the manuscript nor in the package insert. 2.
the procedure describe for the assay in the package insert is for a screening test not for a confirmatory test.
4.
Expert Reviewer 4:
I am not sure how well trained the analysts are in this method, in so many laboratories. There
is no description of the training that was performed, if any, prior to the study. In future, I would recommend
thorough training and a competency panel prior to the testing for the analyst that will be part of the study.
5.
Expert Reviewer 5:
No further comment.
6.
Expert Reviewer 6:
None at this time.
AOAC Research Institute - Expert Review Panel Use Only
Page
5
of
8
Expert Reviewers: 1)Donna Douey, 2)Tom Hammack, 3)Maria Fernandez, 4) Yvonne Salfinger, 5)Tony Hitchins, 6)Michael Brodsky