AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

Challenges

ƒ The Abbott et. al. Guidance document discussed spiking allergens into matrices to evaluate recovery. ƒ The Koerner et al. paper briefly touched on recovery studies, but did not mention the differences between wheat, barley and rye. ƒ In the case of determining gluten levels in oats, we think that barley will be a significant source of contamination, so it will be critical to understand the kit response to barley as well as wheat. ƒ Rye can be found in oat streams in North America, but not nearly to the extent as wheat and barley. ƒ Therefore, a method for estimating response of three contaminant grains independently is being proposed in this study.

Concept

ƒ The concept will be to obtain gluten-free oat flour, and contaminant grains. The contaminant grains will be ground to particle size similar to flour, and then analyzed by some “ reference ” method for gluten content. ƒ The contaminant flours will then be quantitatively spiked into the oat flour. ƒ In order to estimate the responses of the three contaminant grains individually, there will necessarily need to be three series of spiked flour samples, one each for wheat, one for rye and one for barley. ƒ Kit developers will be provided instructions to analyze the series of samples (with replication to calculate precision) and calculate % Recovery estimates for the three grains.