Microsoft Word - Candidates for 2018 ERP of the Year

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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. 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"). ER 2 Can the applicability or scope be moved out of the "Principle" section higher up under the title? ER 3 ER 4 A significantly improved write-up for this collaborative study

03/12/2018