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EXPERT REVIEW PANEL, METHOD BACKGROUND, AND CONCLUSIONS
Criteria for Vetting Methods to be considered:
AOAC convened the
Official Methods of Analysis SM
(OMA) Expert Review Panel for Food Allergens – Gluten on
Thursday, March 19, 2015 during the AOAC Mid-Year Meeting located at the Hilton Washington DC North, 620
Perry Parkway, Gaithersburg, Maryland 20877.
The purpose of the meeting was to review and evaluate 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 and OMAMAN-20: R-Biopharm, Qualitative Detection of Gluten on Surfaces
and In Processed and Non-Processed Products by R5 Immuno-Chromatographic Dip Stick.
The co-study directors for OMAMAN-19 were Dr. Markus Lacorn from R-Biopharm AG, located at An der neuen
Bergstraße 17, 64297 Darmstadt, Germany and Patricia Meinhardt of R-Biopharm Inc. located at 870 Vossbrink
Drive, Washington, MO 63090. The candidate method (OMAMAN-19) was reviewed and supplemental
information was also provided to the reviewers which included the collaborative study manuscript, method
safety checklist, MSDS for Conjugate, MSDS for Sample Dilute, MSDS for Standard, AACC Published Article
(includes protocol), In-house validation report, the package insert, Expert Review Panel Chair Report, AOAC CSO
Memorandum, second set of reviewer comments and a presentation of next steps for OMAMAN-19.
The co-study directors for OMAMAN-20 were Dr. Markus Lacorn and Thomas Weiss from R-Biopharm AG, located
at An der neuen Bergstraße 17, 64297 Darmstadt, Germany. The candidate method (OMAMAN-20) was reviewed
and supplemental information was also provided to the reviewers which included the collaborative study
manuscript, AACC Technical Committee report, method safety checklist, method user guide, MSDS for the cocktail
solution, MSDS for sample dilute, MSDS for Ethanol, Preamble of Corporate Design, and the In-house validation
report.
Criteria for Vetting Experts and Selection Process:
The following ten (10) candidates and one (1) alternate member were submitted for consideration by the
Official Methods Board to evaluate candidate methods for food allergens (gluten) as per the Expert Review
Panel (ERP) Policies and Procedures. The following candidates are highly recommended by the Food Allergens
Community and other Food Allergen experts. Many of the following candidates have participated in various
AOAC activities, including but limited to, members of Committee H, and expert reviewers for the AOAC Research
Institute’s PTM Program. The members are Shang Jing Pan (Co-Chair), Terrence Koerner (Co-Chair), Sneh
Bhandari, Joe Boison, Clyde Don, Eric Garber/ Girdhari Sharma (Alternate), Todd Marrow, Bert Popping, Paul
Wehling, and Jupiter Yeung.
ERP Orientation:
All ERP members have completed the mandatory AOAC Expert Review Panel Orientation Webinar.
Expert Review Panel Meeting Quorum
The meeting of the Expert Review Panel was held in person. A quorum is the presence of seven (7) members or
2/3 of the total vetted ERP, whichever is greater. Eight (8) out of the ten (10) members and one (1) alternate,
were present and therefore met a quorum to conduct the meeting.
Standard Method Performance Requirements (SMPRs):
N/A
ERP PROFILE SUMMARIES
216