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.] “
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