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 ER 6 No, The described scope and applicability of the kit is not supported for all the mentioned matrices or big categories. ER 7 Yes ER 8 No, no surface swab data. No data or reference cited to claim no high-dose hook effect in page 3, line 82. Supporting Data and information: Does data collected support the criteria given in the collaborative study protocol? ER 1 Yes ER 2 no ER 3 No protocol was provided to the ERP ER 4 Yes ER 5 Yes ER 6 The ERP was not consulted in creating protocols for the study. I am not finding those ready accessible. ER 7 Yes ER 8 No, no surface swab data. No data or reference cited to claim no high-dose hook effect in page 3, line 82. Are there any concerns regarding the safety of the method? ER 1 No ER 2 none ER 3 no ER 4 No ER 5 So far no comments, all necessary precautions are well described ER 6 Yes, the use of ethanol and the cocktail may have some safety issues but those have been addressed by the authors in the manuscript. ER 7 NA ER 8 No Are there any concerns regarding the data manipulation, data tables, or statistical analysis? ER 1 No ER 2 Yes, the authors undermine the statistical evaluation when an excuse is given that two samples were 'apparently' swapped by a lab instead of accepting the results and performing the statistical analysis.
ER 3 ER 4 ER 5 ER 6
Yes - need to consult Stats Committee for further discussion of the procedures given here.
No
Some of the tables need editing (titles look blurred sometimes)
The data presented in Table 2 suggest that for the sample 5 three of the labs. Could not detect it positive in most of their tested 10 replicates (0-1 out of 10) whereas the remaining labs did report 7-10 positives out of tested 10 replicates of the sample. The sample contains 3.2 mg gliadin/kg. The Result Reporting section of the manuscript states that a negative result is
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