AOAC GFA Stakeholder Program Meeting Book (August 29, 2021)

Format 1. Scope 2. Applicability 3. Terms and Definitions

Combined Resources/Guidance • Table 1: Selectivity panel selection • Annex A: Preparation of Food and Ingredient Testing Materials for Food Allergen Method Validation • Annex B: Preparation

4. Required Method Information 5. Quantitative Method Validation 1. General Study Practices 2. Single Lab Validation (Method Developer Study) 3. Independent Laboratory Study (PTM) 4. Collaborative Study 6. Qualitative Method Validation 1. General Study Practices 2. …

Draft Validation Guidance on Food Allergen Immunoassays

of Environmental Samples for Food Allergen Method Validation

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Initial Subgroups • Testing Materials- Foods and Ingredients o Provide guidance on how to prepare testing materials (foods and ingredients) for method validation studies • Testing Materials- Environmental Samples o Provide guidance on how to prepare testing materials (environmental samples) for method validation studies • Reporting units o Provide guidance on which reporting units are required/acceptable for allergen analysis, what information is required on method calibrants, and how unit conversions should be derived • Additional acceptance criteria/information o Provide guidance on how cross-reactivity and specificity should be assessed, how LOQ should be evaluated, and how methods should consider application for risk assessment purposes

Validation Guidance: Information to Fill the Gaps

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