AOAC ERP Gluten Assays - Dec 2018

OMAMAN‐47: Quantification of Wheat, Rye, and Barley Gluten in Oat and Oats Products SUMMARY OF COMMENTS  ER 2 Yes.

Yes, though additional individual data points for wheat and rye would have been beneficial.

ER 3

The method has defined the basis for a rationally and scientifically meaningful collaborative  study No. The only data to calculate accuracy of the method comes from reference material of 10  mg/kg gluten. The method should also be validated against the 20 mg/kg gluten reference  material and other samples, where possible, used in the study. The results of the collaborative test with 19 participating laboratories showed recoveries  ranging from 99 to 137 %  (recovery data for specific samples not available) for all three grain  sources. Relative reproducibility standard deviations for samples >10 mg/kg ranged from 10 to  53 %. The collaborative study results confirmed that the method is accurate and suitable to  measure gluten from all three grain sources, and has demonstrated performance on oat matrices which meets the criteria as specified in SMPR 2017.021. Yes, the data submitted allow evaluating the method against MPCs  Does the data collected support the criteria given in the collaborative study protocol? yes

ER 4

ER 5 ER 6

ER 7 ER 8 ER 1 ER 2 ER 3 ER 4 ER 5 ER 6 ER 7 ER 8

Yes Yes Yes yes Yes yes

The study captures the recommendations and guidlines provided in the SMPR Yes. Are there any concerns regarding the safety of the method? Please refer to the review  provided by the Safety Advisor.

No No.

ER 1 ER 2

No, but I do wonder if they are able to move this kit to the more "ecological" cocktail  extraction, in order to eliminate the 2ME ‐ especially because of the large volume of Cocktail  being used per sample.

ER 3 ER 4 ER 5 ER 6 ER 7 ER 8

Not at this point

The method has safety statement.

yes

No significant safety concerns

No Are there any concerns regarding the data manipulation, data tables, or statistical analysis?  Please refer to the review provided by the Statistical Advisor.

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