203 / 328
Do you agree that the evidence or data from this and previous studies support the proposed applicability
statement?
ER 1
No
ER 2
Yes
ER 3
Yes
ER 4
Yes
ER 5
Yes
ER 6
No
Are there sufficient data points per product evaluated in accordance with AOAC requirements?
ER 1
No
ER 2
Yes
ER 3
Yes
ER 4
Yes
ER 5
NA
ER 6
Yes
General Comments about the Method Scope/Applicability:
ER 1
The method is marketed for the detection of hydrolyzed gluten. Standards for the use of the
term gluten-free are focused on 20 ppm. As such, the method's repeated use of different units
(prolamin) confuse. Further, the product is marketed for the quantitative detection of
hydrolyzed gluten yet the number of gluten concentrations examined do not properly
bracket & include 20 ppm. The number of food matrices are insufficient and none of the
products had gluten incurred prior to processing at defined levels. The 'incurred' food samples
were commercially acquired and the true gluten content was unknown necessitating using
the assay to determine content, circular logic more appropriate for a proficiency test and not
validation.
ER 2
Can the applicability or scope be moved out of the "Principle" section higher up under the
title?
ER 3
A significantly improved write-up for this collaborative study
ER 4
The R5 competitive ELISA is the only method so far that can detect and quantify partially
hydrolyzed gluten. It is clear from literature that R5 sandwich ELISA will not work properly.
Some criticism may be given on the calibrator used and the calibration using method
software (cubic spline) and fixed cut-off. Accuracy may be questioned, but considering we are
dealing with an ELISA method dealing with a complex analyte, and looking at previously
published results with ELISA methods, the "inaccuracy" is within the scope of other results
reported. Still the method shows an LOD that is well-below action level, for most allergen
ELISA the emphasis is on LOD. For example Codex 118-1979 (rev 2008) states an LOD of 10
mg/kg, there is no mentioning of an LOQ requirement in Codex. Technicality: Immuno-
stimulatory may be right, but immuno-stimulatory does not mean it will cause an adverse
reaction, from QQPFP we know it always will cause an adverse reaction (hence called "toxic").
ERP PROFILE SUMMARIES
167