AOAC Guidance on FA Immunoassay Validation (August 2023)

Guidance on Food Allergen Immunoassay Validation 1 Food Allergen Working Group Draft for Public Comment, August 30, 2023

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Contents 1. Scope

2. Applicability

3. Terms and Definitions

3.1. General

3.2. Quantitative Methods 3.3. Qualitative Methods

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4. Required Method Information

4.1. General Method Information

4.2. Reporting Units

4.3. Calibrant

4.4. Test material preparation 4.5. Antibody description 5. Quantitative Method Validation 5.1. General Study Practices

5.2. Single Laboratory Validation Study (Method Developer Study)

5.2.1. Scope

5.2.2. Calibration Fit Study 5.2.3. Selectivity Study 5.2.4. Matrix Study 5.2.5. Robustness Study

5.3. Independent Laboratory Study (PTM)

5.3.1. Scope

5.3.2. Matrix Study 5.4. Collaborative Study

5.4.1. AOAC Requirements

5.4.2. Scope

5.4.3. Number of Laboratories

5.4.4. Test Materials 5.4.5. Data Analysis

5.4.6. Acceptance Criteria

6. Qualitative Method Validation 6.1. General Study Practices

6.2. Single Laboratory Validation (Method Developer Study)

6.2.1. Scope

6.2.2. Selectivity Study 6.2.3. Matrix Study 6.2.4. Robustness Study

6.2.5. High-Dose Hook Effect Study 6.3. Independent Laboratory Study (PTM)

6.3.1. Scope

6.3.2. Matrix Study 6.4. Collaborative Study

6.4.1. AOAC Requirements