AOAC ERP Gluten Assays - March 2019
CHECKLIST FOR FINAL ACTION METHOD RECOMMENDATION 2012.01: GLIADIN AS A MEASURE OF GLUTEN IN FOODS CONTAINING WHEAT, RYE, AND BARLEY, ENZYME IMMUNOASSAY METHOD BASED ON A SPECIFIC MONOCLONAL ANTIBODY TO THE POTENTIALLY CELIAC TOXIC AMINO ACID PROLAMINE SEQUENCES, FIRST ACTION 2012 OMB GUIDANCE FOR AOAC ERPS Considered? Comments Method Applicability Yes The determination of gluten in rice flour and rice
based unprocessed and processed foods as specified in the applicability statement. All addressed prior to First Action. Reference materials are addressed in the protocols for SLV. AOAC Performance Tested SM cert.: 120601; Harmonized PTM‐OMA
Safety Concerns Reference Materials
Yes No
Single Laboratory Validation
Yes
Immer et. al., J. AOAC Int . 95 , 1118 (2012)
Reproducibility/Uncertainty and Probability of Detection
Yes
Comparison to SMPR
No
SMPR, not applicable. This method was validated by previous AOAC Committee D/E prior to the establishment of the Expert Review Panels.
Feedback from Users of Method
Yes
Discussed in ERP meeting
ERP Recommendation to Repeal First Action Method
Not Applicable
DOCUMENTATION Safety Evaluation Reference Materials
Available?
Comments
Yes No Yes Yes Yes Yes No Yes Yes Yes Yes
Completed prior to AOAC First Action
In manuscript
SLV or PTMs
AOAC PTM cert.: 121301; Harmonized PTM‐OMA Precollaborative, Independent, Collaborative
Approved Validation Protocols
Statistics Review
Completed prior to AOAC First Action
Method Published in OMA
2014.03
Method Performance vs SMPR criteria
SMPR, not applicable. This method was validated using the guidance of OMA Appendices D, M, and N. Discussed in ERP meeting
Feedback Information Additional Recognition(s)
AOAC PTM cert.: 120601
ERP Reports
September, 2016
Immer et. al., J. AOAC Int . 95 , 1118 (2012)
Manuscript(s) Published in JAOAC
Method Recommended for Final Action
Yes
The OMA title was changed to “Gliadin as a Measure of Gluten in Rice and Corn Based Foods” in lieu of “Gliadin as a Measure of Gluten in Foods Containing Wheat, Rye, and Barley”
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