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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
Cons/Weaknesses of the Manuscript:
1.
Expert Reviewer 1:
RESULTS SECTION: Tables 2013.xxA and B are clear, but the explanation and rationale were not. First
paragraph - OK Second paragraph - should be clearer. For example, for exclusivity, should have been 756 results, 21
excluded for NG of E. cloacae on all 7 media, Another 44 results (I believe) were excluded for other various reasons of
NG, leaving 691 analysis to perform. But 6 more were excluded as it was concluded that the slants had become
contaminated at some point. Now down to 685 results to analyse. Not easy to follow so my numbers may be off.
DISCUSSION SECTION: Not clear which 3 labs data were excluded from analysis. Lab 16, 2 and 13 all reported a higher
level of false positives and likely the ones excluded, but when considering only data from the 15 labs without clusters of
aberrant results, accuracy on the inclusivity is reported at 100% which discounts the negative Lab 2 obtained on a
Salmonella Enteritidis. The rationale for the False positives were attributed to cross contamination. This rationale would
not apply to a false negative. The false negative obtained by Lab 2 should be included or rationale provided as to why this
result is excluded. The false negative is reported in the discussion section as having occurred, but no rationale is provided
for excluding this result.
2.
Expert Reviewer 2:
None.
3.
Expert Reviewer 3:
Salmonella Weslaco was not detected
4.
Expert Reviewer 4:
This type technology has the capability to facilitate more rapid turnaround of results. The main
concern, however, is the number of false-positives. The impact of such results would be that there would potentially be a
recall. On the other side, these colonies might not even be picked depending on their growth characteristics on the
different medias.
5.
Expert Reviewer 5:
Apart from having to unavoidably dwell on explaining false and unexpected negative results, there
are no basic weaknesses. It seems surprising that the the preparing laboratory and the testing laboratories did not check
for growth on the distributed culture slants. Also, perhaps the technical manipulations should be conducted in some kind
of biological hood.
6.
Expert Reviewer 6:
No indication of the interpretation of the criteria used to define isolates growing on
selective/differential as presumptive Salmonella or not.
Supporting Data and Information
(General comments and method optimization/precollaborative/single laboratory validation)
:
1.
Expert Reviewer 1
Yes
2.
Expert Reviewer 2
Yes.
3.
Expert Reviewer 3
yes
4.
Expert Reviewer 4
No, depending on how the results due to the false-negatives are viewed.
5.
Expert Reviewer 5
Yes
6.
Expert Reviewer 6
Yes, assuming that the organisms are correctly identified, particularly Salmonella sp.
Does the data collected support the criteria given in the collaborative study protocol?
1.
Expert Reviewer 1
Yes
2.
Expert Reviewer 2
Yes.
3.
Expert Reviewer 3
yes
4.
Expert Reviewer 4
The data supports the results as written.
5.
Expert Reviewer 5
Yes
6.
Expert Reviewer 6
Yes, assuming that the organisms are correctly identified, particularly Salmonella sp.
AOAC Research Institute - Expert Review Panel Use Only
Page
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of
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Expert Reviewers: 1)Donna Douey, 2)Tom Hammack, 3)Maria Fernandez, 4) Yvonne Salfinger, 5)Tony Hitchins, 6)Michael Brodsky