OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

Validation Report  Additional data for AOAC OMA First Action 2015.05  RIDASCREEN® Gliadin competitive R7021 for transition to OMA Final Action status 

Thomas Weiss 1 , Markus Lacorn 1 , Patricia Meinhardt 2 , Thomas Hektor 1

1 R‐Biopharm AG, An der neuen Bergstr. 17, 64297 Darmstadt, Germany  2 R‐Biopharm Inc., 870 Vossbrink Drive, Washington, MO 63090, USA 

1. Introduction  In March 2015, the AOAC ERP Gluten decided to grant OMA First Action (2015.05) status for  RIDASCREEN® Gliadin competitive R7021. For Final Action approval, the method developer was asked  to provide additional in‐house validation data at and below 20 mg/kg for rye and wheat. Data for barley  were judged to be sufficient since spiked beer samples were used at concentrations of 15 and 50 mg/kg  hordeins. This report contains results from syrup samples spiked with intact and partially hydrolyzed  gliadin, sourdough samples spiked with intact and partially hydrolyzed secalin, QC data to show  performance at the method developer’s site, and finally results from a PT round using three beers with  different gluten contents. During the next ERP meeting the data from this report will be presented by  the method developer for discussion and decision.  2. Materials and Methods  2.1 Spiking materials  Prolamin Working Group  gliadin  standard (van Eckert et al. 2006); Gliadin concentration was defined  by weigh‐in corrected for total protein content of the material.    Partially hydrolyzed gliadin  (Gessendoerfer et al. 2009); starting material was the PWG gliadin;  hydrolyzed material was obtained from Prof. Köhler DFA Freising; concentration was defined by weigh‐ in corrected for total protein content.   Purified  secalin  was extracted from rye variety Nikita (Gessendoerfer et al., 2009); material was  obtained from Prof. Köhler DFA Freising; secalin concentration was defined by weigh‐in corrected for  total protein content.   Partially hydrolyzed secalin  was produced according to Gessendoerfer et al. (2009) form the rye  variety Nikita; material was obtained from Prof. Köhler DFA Freising; concentration was defined by  weigh‐in corrected for total protein content. 

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