Microsoft Word - Candidates for 2018 ERP of the Year

197

Cons/Weaknesses of the Manuscript: ER 1

The field is a sensitive one. Meaning, anything with the potential to mislead can cause more problems than it would solve. Unfortunately, the manuscript needs serious tweaking to its language. Missing the results of labs E, F, and K that have been listed in the AACCI validation report. I have some concerns that 3 out of 16 labs were not technically competent to perform this method. I can't tell if the average calculation of the 5.3 ppm gliadin in the naturally gluten-contaminated starch syrup (Sample 5) includes results that are all from the cubic spline calculation or a combination of cubic spline and second- order polynomial curve as some of the lab results are lower than 5 ppm. I'm assuming that even the results below 5 ppm were calculated by cubic spline. None that could be identified even though I wondered if the method will always have to be operated in a separate test room under normal circumstances. For the Collaborative study, participants were advised to carry out the test in a separate room due to the low detection limit and the possibility of contamination. The hydrolyzed standards may not detect intact gluten accurately. The accuracy of the method towards hydrolyzed gluten can not be ascertained from recoveries since the gluten concentration used for spiking was also determined by this method for sourdough and the gluten in starch syrup was unknown. Also it is not clear if the gluten spiked in beer was PT-hordein or mixture of PT-digests from wheat, rye and barley. The LOD and LOQ is not calculated from this study, though discussed in the in-house validation and the AACCI paper. data is not complete There are some typos and broken links to references.

ER 2

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ER 7 ER 8 Supporting Data and Information: Does data from collaborative study support the method as written? ER 1

technically yes, however the need to drop 3 labs from the collaborative study and upon reviewing the data the observation that a significant variance still occurred with a few labs, makes the issue of method precision real (though not unexpected considering such is common with competitive ELISAs)

ER 2 ER 3 ER 4 ER 5 ER 6

Yes yes Yes.

I believe that he data collected supports the AACCI guidelines as written.

The method is unclear as the PT-hordein is discussed as used in beer spiking, while the section F of the method mentions the spiking material was identical to standard solution (PT fragments from wheat, rye, barley). Also the actual gluten in rye sourdough cannot be determined by the method used for validation. What was the gluten concentration based on the amount in rye used for sourdough preparation.

ER 7 ER 8 Supporting Data and information: Does data collected support the criteria given in the collaborative study protocol? ER 1 Yes ER 2 Yes ER 3 yes ER 4 Yes.

03/12/2018