AOAC-RI ERP Book - Gluten.pdf

Are there any reference materials considered or addressed?

Yes

NIST egg powder, NIST non-fat milk powder

The study did not use any reference materials because any not available at that time. It did use FAPAS Proficiency Test samples 2781 and 2792 and 2795. I would be interested to see any available PT data on this method at time of final action. For gluten methods we see that single lab studies, collaborative studies, scientific papers and preparation of spiked samples refer to the use of PWG gliadin. Sometimes wheat flour calibrated against PWG gliadin. This in lack of a CRM, but also still part of this ERP's ongoing discussions Wheat gluten calibrator was calibrated against the commercially available WGPAT gliadin (86% highly purified gliadin from 40 different European wheat variety. However, this is not the only wheat reference material available.

No No

No

Yes

Are the approved validation protocols available and documented?

Yes No Yes Yes Yes

Is the method documentation available that demonstrates Reproducibility/Uncertainty and Probability of Detection? If so, please cite the reference.

STATISTICAL REVIEW: Is the documentation for the statistical review prior to AOAC First Action Official Methods status available and completed?

Yes Statistics review completed at the time of adoption as First Action method n/a - performed at 1st action stage. ? Currently there is no SMPR for gluten ELISA available. Statistic were done according to App M.

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Method Performance Feedback 2014.03