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”