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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

6.

Are there sufficient data points per product evaluated in accordance with AOAC requirements?

1.

Expert Reviewer 1

yes

2.

Expert Reviewer 2

yes

3.

Expert Reviewer 3

yes

4.

Expert Reviewer 4

yes

5.

Expert Reviewer 5

yes

6.

Expert Reviewer 6

yes

General Comments about the Method Scope/Applicability:

1.

Expert Reviewer 1

: Appendix J requires that all media recommended for use with the candidate method must be tested

by the Independent Laboratory. The media used were the selective / differential media of the FSIS and FDA Salmonella

methods (six agars), plus one non-selective agar. However the applicability statement is not restricted to these media. A

suggestion - the applicability statement could either state the specific media the method can be used with, or state

"Applicable to the identification of colonies presumptive of Salmonella spp. taken from specific selective / differential

agar media", then these could be listed in the method. Or is the conclusion being made that this method is now

applicable to all selective / differential media for Salmonella?

2.

Expert Reviewer 2

: It should be made clear in the method that only the agars tested in the validation study (BGS, BS,

DMLIA, HE, TSA, XLD, and XLT-4) can be used in the method.

3.

Expert Reviewer 3:

ANSR® for Salmonella Assay for Identification of Salmonella spp. from Colony Picks from

Selective/Differential Agar Media: Collaborative Study is very useful as a confirmatory test.

4.

Expert Reviewer 4:

I have concerns about the false-positive results. Even though they seemed to be clustered, this would

be very bad to report out a non-Salmonella as a positive CONFIRMED result for Salmonella (24/685 results). As a

screening tool, this would be acceptable, as confirmation would continue. As a confirmatory tool, this is not acceptable.

Since there were technical issues in some of the laboratories, I am wondering how well the specific analysts were trained

prior to testing. But 7 results were more sporadic, so that is also of concern. The one false-negative was also produced in

one of the laboratories that had a high number of false-positive results. However, there were also 3 false-positive results

in the pre-collaborative study.

5.

Expert Reviewer 5:

This collaborative and single laboratory study extends and validates the applicability of the ANSR

Salmonella method to identification of colony picks from Salmonella selective and differential media. A PTM study of its

use in Salmonella detection in foods and on environmental surfaces has been approved previously but it is not clear

whether those applications will be collaboratively studied.

6.

Expert Reviewer 6:

There is no reference to verification of the test cultures as Salmonella sp. in this report or the pre-

collaborative study. Other than the authors' claims and the ability of the isolates to grow on various selective/differential

media, there is no indication of any criteria used to validate the identity of the isolates used.

AOAC Research Institute - Expert Review Panel Use Only

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Expert Reviewers: 1)Donna Douey, 2)Tom Hammack, 3)Maria Fernandez, 4) Yvonne Salfinger, 5)Tony Hitchins, 6)Michael Brodsky