AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

Concept

ƒ This experiment will be performed by the kit developer as part of the Single Laboratory Validation (SLV) protocol. ƒ The experimental parameters generated for the kit will then be verified/tested independently by a 3rd Party Laboratory. ƒ This exercise will be conducted only on oat flour samples provided as a test of kit/antibody response. ƒ It is anticipated that method precision will need to be demonstrated on each claimed matrix by SLV and multi- laboratory validation (MLV) experiments as required by the SMPR. ƒ In addition, test kit developers will also be required to demonstrate ruggedness, inclusivity, exclusivity as described in the two Guidance documents by Abbot et al. and Koerner et al.

Gluten-Free Oat Flour ƒ General Mills has obtained very low Gluten-Free oat flour for spiking materials by mechanically cleaning oats and selecting the fraction expected to be lowest in gluten. ƒ For spiking purposes, we have identified flour lots with an observed analytical mean < 1 ppm gluten as tested by the R5 ELISA method, 18 replicates at 5 g test portion. ƒ Flour at this level is deemed low enough and suitable to be used in spiking experiments.