RI-ERP-FINALACTION-Recommendations

AOAC RESEARCH INSTITUTE AOAC OFFICIAL METHODS OF ANALYSIS (OMA)

OMAMAN-20: R-Biopharm, Qualitative Detection of Gluten on Surfaces and In Processed and Non- Processed Products by R5 Immuno-Chromatographic Dip Stick Study Director: Dr. Markus Lacorn & Thomas Weiss, R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany expected if the sample contains less than 4 mg gliadin/kg. 15 of the labs out of 18 reported positive result for this sample and 3 negative. Thus 83% of the participating lab found the sample positive and about 17% negative. Does this mean that Result reporting key presented in the manuscript need a revision or a review? Three labs which found sample negative reported 9-10 tested replicates of the samples negative and the labs which found positive most of the tested 10 replicates positive. This can lead to an issue when the assay is put in operation and the same sample if tested by different labs, 17% labs can come up with negative results while the remaining labs will call it a positive with respect to gluten.

ER 7 ER 8

NA

OMA Statistic Advisor should review the proposed statistical approach and justifications.

General Comments (2) ER 1 NA ER 2

If there was a serious problem with the data analysis using by-eye examination, why not use a dip-stick reader?

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

NA NA NA

The manuscript throughout except few places in text provides result as mg gliadin/kg. Gliadin in parenthesis may be added in title of the manuscript after mention of Gluten.

NA

NA EDITORIAL EVALUATION CRITERIA Is the Validation Study Manuscript in a format acceptable to AOAC? ER 1 Yes ER 2 Yes ER 3 Yes ER 4 Yes ER 5 Yes ER 6 Yes ER 7 Yes ER 8 Yes

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