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clear throughout the paper
ER 5
The manuscript is technically and scientifically sound
ER 6
The method is useful in qualitative detecting of gluten in non-processed and processed foods
relatively rapidly. It's utility is also in rapid detection of surface contamination by gluten. Data
presentation and the manuscript are easy to understand.
ER 7
NA
ER 8
The strength of the manuscript is also a weakness of the validation study. The authors offered
an alternative statistic approach to define the minimum level in a positive result and a
maximum level in a negative observation. This is important for the end users or manufacturers
to make an informed risk based management decision, and this information is lacking in
Appendix N.
Cons/Weaknesses of the Manuscript:
ER 1
Study lacks validation of method for surfaces
ER 2
Considering the manufacturer's reputation and the quality of the product, a more serious
submission was expected.
ER 3
Lack of clarity around use of gliadin and gluten - it seems the terms are used interchangeably. I
feel the authors need to go one way or the other. Personally, I prefer gluten as a basis, since
gluten is in the title of the method.
ER 4
My only concern is that since this is a test kit to detect gluten as the title says why is it that the
authors are not reporting the detected as gluten when it is well known that there is always a
factor of 2 to be applied to the gliadin concentration. Why do they have to leave it to the end
user to do that simple arithmetic in order to define whether the test result is compliant with
international (Codex) guidelines or not.
ER 5
Perhaps a very technical write-up which could be improved on readability.
ER 6
The reproducibility of the assay has been evaluated in corn sample and processed samples like
cookies and corn snacks. The reproducibility of the assay performance was not done for non-
processed samples like wheat, rye and barley which are indicated in the scope of the kit. The kit
is suggested to have great utility in rapid detection of surface contamination by gluten. But the
reproducibility of this type analysis was not undertaken in the collaborative study.
ER 7
NA
ER 8
The study design deviates from the Appendix N. There is no defined LOD. The study should also
include product consistency, shelf-life or stability of the kit, Lot-to-lot consistency, and
consistency within same lot studies.
Supporting Data and Information: Does data from collaborative study support the method as written?
ER 1
Yes
ER 2
no
ER 3
yes
ER 4
Yes
ER 5
The collaborative study supports the potential of this method as shown in the SLV/in house
study. Although corn is the most used base in the collab.
ERP PROFILE SUMMARIES
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