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ER 5
I believe that the data collected in the collaborative study does not meet the AOAC guidelines or the
guidance developed from the AOAC food allergen community for gluten analysis. The data collected for
the beer matrix is not appropriate for Appendix D is the strictest sense. I believe the method should be
tested at the CODEX recommended level for gluten free foods (20mg/kg of gluten or 10mg/kg prolamin)
and the sample concentration should backed this concentration. The AOAC guidance on gluten ELISA
methods suggest even more concentration levels should be studied. The same criteria should be used for
the other two matrices tested.
ER 6
Yes, the data collected from various laboratories are in accordance with the study protocol.
ER 7
ER 8
Are there any concerns regarding the safety of the method?
ER 1
No
ER 2
No
ER 3
no
ER 4
No.
ER 5
No
ER 6
No
ER 7
ER 8
Are there any concerns regarding the data manipulation, data tables, or statistical analysis?
ER 1
yes, see item above regarding the dropping of three labs and the remaining variance in the data.
ER 2
As previously mentioned, how was the 5.3 ppm result for the naturally contaminated sample derived. I'm
assuming all results were calculated with the RIDASOFT software.
ER 3
yes. the original data table (including lab E, F, K, table 1 in AACCI publication) should also be included in
the manuscript
ER 4
The statistical advisor's review was not available at the time of this review.
ER 5
No
ER 6
No
ER 7
ER 8
General Comments (2)
ER 1
see above
ER 2
ER 3
ER 4
ER 5
NA
ER 6
ER 7
ER 8
EDITORIAL EVALUATION CRITERIA
Is the Validation Study Manuscript in a format acceptable to AOAC?
ERP PROFILE SUMMARIES
209