RI-ERP-FINALACTION-Recommendations

OMAMAN-20 C/ In House Validation Report ERP Use Only - March 2015

After Cocktail extraction, wheat, rye, barley and the WGPAT material showed comparable sensitivities (table 2). The variation of results for the 2 mg/kg concentration is due to the fact that this concentration is close to the POD50. It could be speculated that wheat has a somewhat higher sensitivity than the WGPAT material since some positive results were detected at 1 mg/kg. One false-positive result was detected for "barley" . Out of a total of 316 tested blank samples during this in-house study, this was the rare case in which a false-positive occurred. Since there was some variation in the results and sensitivities, POD curves are provided in Fig. 3.

Figure 3. Probabilities of detection (POD) for target compounds (Cocktail extraction); highest concentration of 16 mg/kg not shown since all PODs are 1.0.

4.1.3 Selectivity Study: Non-Target compounds The non-target selectivity panel (table 3) is slightly modified but still according to Koerner et al. (4) and represents the opinion of the AOAC Allergen community. Some commodities were added to the list due to long lasting experiences of the manufacturer. All non-target compounds are checked to be gluten-free by the Gliadin sandwich ELISA. In total, 68 commodities were tested. The commodities were extracted once like a sample both with 60% ethanol (3.7.2.3) or Cocktail/80% ethanol (3.7.3) and were tested in the RIDA®QUICK Gliadin with 2 replicates. Analysis will be performed as described in chapter 3. Table 3 clearly shows that no cross-reactivity exists against the 68 tested commodities irrespective of the extraction procedure. A lot of these commodities are used to compose alternative food for coeliac patients.

AOAC Research Institute Expert Review Panel Use Only

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RIDA®QUICK Gliadin Validation report 2015-01-14