OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

AOAC RESEARCH INSTITUTE AOAC OFFICIAL METHODS OF ANALYSIS (OMA) OMAMAN-19: R-Biopharm, Competitive Enzyme Immunoassay Based On The R5

Monoclonal Antibody To Determine Partially Hydrolysed Gluten In Foods Containing Wheat, Rye, And Barley Study Director: Dr. Markus Lacorn, R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany/ Co- Study Director: Patricia Meinhardt, R-Biopharm Inc., 870 Vossbrink Drive, Washington, MO 63090 RECOMMENDATION: Do you recommend that the ERP adopt this method as an AOAC Official Method of Analysis (First Action status) ? ER 1 no ER 2 no - manuscript still has too many deficiencies ER 3 Yes ER 4 Yes, but under the condition that some things are done /can be done by the method developer between the stage of 1st Action to Final Action ER 5 Yes. After the gliadin (Gluten) correction is made throughout mss. The LOD of the method requires clarification. Manuscript states 5 mg/kg as LOD determined by manufacturer and they also provide alternate calculation of the LOD = 6.5 mg/Kg. Which value is the represents the method's LOD? This needs to be clarified before method can be recommended to the first action. No AFTER FIRST ACTION STATUS: Is there any additional information that the ERP should consider in order to recommend the method for Final Action status? ER 1 n/a ER 2 yes. Need to collect more data at other levels (20 mg/kg gluten) before final action. ER 3 Feedback from users of the method ER 4 My concern is that by the time to move to final action / accept as final action (2 yrs after 2015) some of the important interlab data presented from AACC will have some years on it since 2011. It may not be a strict rule in AOAC acceptance guidelines to have fresher results, but personally I would like to see some updated results for difficult matrices in multiple labs before we take the final action decision. The estimations of the true value of the secalins in the fermented sourdough were not confirmed by an alternate established method in this as well as the spiked samples. This may result in question to the values used for calculation of spike recovery. This can be further clarified. The authors may provide additional data in different cereal based fermented foods to rule out the possibility of under estimation and false negative in samples which may have endopetidases active towards prolamins. ER 6 ER 5

ER 6

N/A

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