OMB First to Final Action Recommendation Checklist 11-12-18

CHECKLIST FOR AOAC FINAL ACTION METHOD RECOMMENDATION

2015.05 Partially Hydrolyzed Gluten in Fermented Cereal-Based Products R5 Competitive ELISA OMB GUIDANCE FOR AOAC ERPS Considered? Comments Method Applicability Yes

Scope: "[RIDASCREEN® Gliadin competitive ELISA kit is used for the analysis of fermented and hydrolyzed food (e.g., beer, starch syrup, starch, malt extract, sourdough, and soy sauce) that are declared as “gluten-free.” The kit is not applicable for measurement of intact gluten.]" Completed prior to AOAC First Action All addressed No reference materials available. Authors used two (2) internal standards for quantitation.

Safety Concerns

Yes No

Reference Materials

Single Laboratory Validation

Yes Yes

PTM Certification #12061

Reproducibility/Uncertainty and Probability of Detection

Journal AOAC International, Volume 98, Number 5, September-October 2015, pp. 1346-1354(9)

Comparison to SMPR

No Yes

SMPR, not applicable. Discussed in ERP meeting

Feedback from Users of Method

ERP Recommendation to Repeal First Action Method

Not Applicable

DOCUMENTATION Safety Evaluation Reference Materials

Available?

Comments

Yes No

Completed prior to AOAC First Action

No reference materials available. Authors used two (2) internal standards for quantitation.

SLV or PTMs

Yes Yes Yes Yes No Yes No Yes Yes

In manuscript

Approved Validation Protocols

PTM and Collaborative

Statistics Review

Completed prior to AOAC First Action

Method Published in OMA

OMA 2015.05

Method Performance vs SMPR criteria

SMPR, not applicable. Discussed in ERP meeting

Feedback Information Additional Recognition(s)

N/A

ERP Reports

March 2015

Manuscript(s) Published in JAOAC

Journal of AOAC International, Volume 98, Number 5, September-October 2015, pp. 1346-1354(9)

Method Recommended for Final Action Recommended for AOAC Final Action Official Methods status.

APPLICABILITY: “The kit is not applicable for measurement of intact gluten and may not measure or detect all fermented and/or hydrolyzed forms of gluten.] “