AOAC RI ERP Final Action Recommendations - BOOK

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OFFICIAL METHODSSM EXPERT REVIEW PANEL
EVALUATION OF THE ANSR® FOR SALMONELLA ASSAY FOR IDENTIFICATION OF SALMONELLA SPP. FROM COLONY
PICKS FROM SELECTIVE/DIFFERENTIAL AGAR MEDIA: COLLABORATIVE STUDY
General comments about the method:
1. Expert Reviewer 1: The method write up lists only the six differential media validated, as well as the non-selective agar.
To make it clearer that the method is only applicable to these media, Section D on preparation of test samples could be
amended to state that the isolated colony is picked from one of the media listed in section B, Media and Reagents.
Otherwise the method write-up seems clear, as much as I can determine without actually performing the method.
2. Expert Reviewer 2: N/A
3. Expert Reviewer 3: This test allow to confirm Salmonella from selective media without the necessity of perform
biochemical and serological identification in a short time.
4. Expert Reviewer 4: 1. p. 1, line 24-The abstract of the collaborative study manuscript should mention that Salmonella
Weslaco produced the 1 false-negative result (so it stands out in the abstract for the reader). 1. 2. p. 2, line 5 The
collaborative study protocol cited USDA FSIS method 4.5. The collaborative study manuscript cited USDA FSIS method
4.06. 3. p. 2, line 26 and p 25, line 5 and p. 30, line 21-The pre-collaborative study says it used 38 non-Salmonella strains
in one place and 37 in another; the collaborative study manuscript say 37 strains. 4. p. 8, line 1-this does not say to use a
new tip for each sample-this should be specified. 5. p. 8, line 11-the package insert says in addition, "The transfer of the
sample from the lysis tubes to the reaction tubes should be completed within 1 minute. This should be added to the
manuscript. 6. p. 9, line 2 and p 25, line 2, p 30, line 16 -the manuscript says 109 serovars, the pre-collab says 109 in
some places and 108 in others, but the collaborative study protocol says 108 (on page 1). 7. p 8, line 2-this does not say
to use a new tip for each sample-this should be specified. 8. p. 30, line 27-now there are 112 inclusive strains with 38
exclusive strains (previously, it was 37 exclusive strains) (but one additional inclusive strain added)-what was the one
added?
5. Expert Reviewer 5: The isothermal nucleic acid amplification method is rapid but more care is needed in stock culture
preparation and in avoiding cross contamination. The false and unexpected negative results in this and perhaps similar
studies might be more readily avoided if the SMPR/Study Guidelines alerted all investigators to these potential problems
with routine culturing and with amplification method cross contamination. In regard to some of these these unexpected
results, when the selective media were streaked from the test culture was a new sterile loop/ needle used for each
medium plate in order to avoid transferring a potential contamination from one kind of medium to another.
6. Expert Reviewer 6: The method appears to be straightforward.
Pros/Strengths of the Manuscript:
1. Expert Reviewer 1: Method write up is generally clear, the tables are easy to interpret.
2. Expert Reviewer 2: The manuscript was clear and concise.
3. Expert Reviewer 3: This method showed to have an excellent specificity with a 99.9% of correct identification of the
salmonella’s assayed by the laboratories which participated in the collaborative study
4. Expert Reviewer 4: This type technology has the capability to facilitate more rapid turnaround of results.
5. Expert Reviewer 5: The manuscript presentation is clear.
6. Expert Reviewer 6: Easy to follow
AOAC Research Institute - Expert Review Panel Use Only
Page 3 of 8
Expert Reviewers: 1)Donna Douey, 2)Tom Hammack, 3)Maria Fernandez, 4) Yvonne Salfinger, 5)Tony Hitchins, 6)Michael Brodsky