271 / 328
Do you agree that the evidence or data from this and previous studies support the proposed applicability
statement?
ER 1
No
ER 2
No
ER 3
No
ER 4
Yes
ER 5
Yes
ER 6
No
ER 7
No
ER 8
No
Are there sufficient data points per product evaluated in accordance with AOAC requirements?
ER 1
Yes
ER 2
No
ER 3
Yes
ER 4
Yes
ER 5
Yes
ER 6
Yes
ER 7
Yes
ER 8
Yes
General Comments about the Method Scope/Applicability:
ER 1
In-house validation report was not available to review the method.
ER 2
The method is well established and is known to generate false positives with soy products (e.g.,
soy milk) that the use of milk powder does not eliminate. This is never mentioned but instead
the use of milk powder is presented as a solution~ .The authors should re-write the documents
with a more open / critical perspective. -There is also a serious question of why they did not
use corn flour that was totally free of gluten and prepare cookies with known levels of 0, etc
etc.
ER 3
none.
ER 4
Method is well written and the experimental details and instructions provided to participants
were very clearly laid out. The pre-collaborative tests were organized properly and sufficient
time was given to participants to demonstrate proficiency prior to undertaking to analyze the
collaborative method samples.
ER 5
The method is very sensitive, I wonder that maybe -looking at the action level of 20 mg/kg- the
LFD method could be too sensitive? Another point as with the R5 sandwich, the gluten content
= 2 x gliadin. Unifying results to gluten content will be helpful instead of using mg/kg gliadin
ER 6
The dip stick assay based on R5 antibody is meant for a rapid qualitative visual detection of
gluten in processed and non-processed samples. The scope of the method to detect intact
gluten (prolamins) includes matrices like corn, wheat, rye and barley. The non-processed
samples are extracted in 60% ethanol and processed samples are extracted in a proprietary
cocktail provided in the kit. The assay has been designed to detect gluten well below the
ERP PROFILE SUMMARIES
231