AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

Standard Method Performance Requirements (SMPRs)

ƒ The gluten working group determined not to set standards for repeatability (RSD r ) reproducibility (RSD R ) because of the inhomogeneity issue discussed in note b about the recovery range. ƒ Method developers will be provided instructions to determine RSD r using standard oat flour samples to be provided under this project.

Parameter

Acceptance Criteria

Analytical Range (ppm) LOD (ppm) LOQ (ppm) Recovery (%) a

” 5 to

” ”

50 to 200 b Not Defined Yet Not Defined Yet

RSD r

RSD R

General Analytical Needs

ƒ General Mills has taken the lead in procuring characterized gluten-free oat flour and also most contaminant grains for this exercise and hope to develop a series of test materials which will be made available to all kit developers to evaluate proposed kit response. ƒ It should be noted that in the past, it was common to use purified protein materials as spiking agents to assess the recovery of kits. ƒ Previous OMA methods had used the PWG gliadin standard as spiking material, with good success. ƒ In this project, it will be difficult to obtain similar materials for hordein and secalin, but in this case, it is believed that it will be appropriate to use unextracted grains as spiking materials since the experiment is intended to demonstrate both the antibody response and the extraction efficiency for the method – it is a validation of the entire kit, not just the antibodies. ƒ As such, it will be better to demonstrate the ability of the method to extract and detect the proteins from grain materials in their native and cooked states.