AOAC Guidance on FA Immunoassay Validation (August 2023)

Annex A

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Preparation of Food and Ingredient Test Materials for Food Allergen Method Validation

1. Food Allergen Materials

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1.1. Use a reference material wherever possible. 1090 1.2. In general, a reference material is representative of the allergenic food commodity, is well- 1091 characterized, can be produced or supplied with robust reproducible characteristics, and can be 1092 used as a calibration standard, control, or spiking material. Food allergens can be present in many 1093 different forms, processed or unprocessed, depending on the food matrix in which they are found, 1094 and with very divergent characteristics and functions in a food. It is unlikely a single material can 1095 represent many different possibilities at once. However, a widely available reference material will 1096 provide a common reference point for data comparison purposes between kits designed for the 1097 same food allergen. 1098 1.3. Alternative materials can be used but must be compared back to reference materials, where 1099 available. Please see Table A1 below for some example reference materials and alternatives. The 1100 alternate materials list is not all inclusive, others may be chosen. Nevertheless, the chosen material 1101 should be representative for a common usage of the allergenic food commodity. 1102 1.4. Alternative materials should be representative for most applications in food industry and should be 1103 commercially available. 1104 1.5. Alternative materials should be minimally processed. For example, processes that may result in 1105 protein fractionation or hydrolysis should not be used. 1106 1107 Table A1: Example Food Allergen Materials. Reference materials and example alternatives available at 1108 time of publication 1109 Reference Material Alternative 1 Alternative 2 Alternative 3 Peanut NIST SRM 2387 Peanut Butter Roasted peanut flour Peanut butter flour Peanut paste Milk Nonfat dry milk (skim milk powder) LGC Skimmed milk powder (LGC7421) NIST SRM 1549a whole milk powder

Egg

NIST 1845a Whole Egg Powder RM 8405 Hazelnut Flour for Allergen Detection RM 8404 Almond Flour for Allergen Detection

Whole Egg Powder Whole Egg Beaters (pasteurized)

Hazelnut

Hazelnut flour

Hazelnut paste

Almond

LGC Almond powder (LGC7424)

Almond flour or paste Walnut paste

Walnut

Walnut flour

Soy

Soy flour

NIST soy flour 3234

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