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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
RECOMMENDATION:
Do you recommend that the ERP adopt this method as an AOAC
Official Methods of Analysis (First Action status)
?
1.
Expert Reviewer 1
Recommendation will be made after discussion with the group at the
meeting. I am generally supportive of adoption of this method.
2.
Expert Reviewer 2
Yes.
3.
Expert Reviewer 3
yes
4.
Expert Reviewer 4
Unless there is convincing information that isolates will not be
misidentified, based on this data, I have difficulty recommending the method.
5.
Expert Reviewer 5
Yes.
6.
Expert Reviewer 6
Yes, assuming that the organisms are correctly identified, particularly Salmonella sp
AFTER
FIRST ACTION STATUS:
Is there any additional information that the ERP should consider in order to recommend the method for Final Action status?
1.
Expert Reviewer 1
Consultation with users on level of false positive results and whether there is a need for a
secondary confirmation step if the method is approved as a stand alone confirmation with
no additional tests required.
2.
Expert Reviewer 2
No.
3.
Expert Reviewer 3
NO
4.
Expert Reviewer 4
1. Would the exclusivity isolates that were misidentified even be picked as presumptive
isolates if grown on the respective medias? 2. Laboratory staff must be well-trained in order
to do these types of methods.
5.
Expert Reviewer 5
This application of ANSR Salmonella should be described in the package insert.
6.
Expert Reviewer 6
No
SAFETY REVIEW
1.
Expert Reviewer 3:
B. The additional risks identified require clarification(s) so as to ensure that the manuscript corresponds to the
approved study protocol and safety guidance.
Biosafety level 2 measures are not mentioned in the in the package insert.
2.
Expert Reviewer 4:
A. The method contains appropriate precautions and potential hazards have been identified corresponding to
the approved study protocol and safety guidance.
The method appears to provide the appropriate precautions, with identification of
potential hazards and contains safety guidance.
AOAC Research Institute - Expert Review Panel Use Only
Page
8
of
8
Expert Reviewers: 1)Donna Douey, 2)Tom Hammack, 3)Maria Fernandez, 4) Yvonne Salfinger, 5)Tony Hitchins, 6)Michael Brodsky