AOAC Guidance on FA Immunoassay Validation (August 2023)

48 49 50 51

6.4.2. Scope

6.4.3. Test Materials 6.4.4. Study Design

6.4.5. Data Analysis, Results Reporting, and Acceptance Criteria

6.4.6. Collaborator Comments 52 53 Table 1: Principal measurands, analytes and measurement systems for allergens 54 Table 2: Required Compounds for Selectivity Study for All Allergen Methods 55 Table 3: Required Compounds for Selectivity Testing for Target Allergen Test Methods 56 Table 4: Optional Compounds of Interest for Selectivity Testing 57 Table 5: Required Test Materials for Quantitative Study Designs 58 Annex A: Preparation of Food and Ingredient Testing Materials for Food Allergen Method Validation 59 Annex B: Preparation of Environmental Samples for Food Allergen Method Validation 60 Annex C: Statistical Methods: Data Analysis Guidance and Example Datasets 61