AOAC ISPAM Stakeholder Panel Meeting Book 3-13-18

DRAFT AOAC SMPR® for Milk Allergen Version 7; November 13, 2017 1 2 Quantitation of Milk by ELISA-based Methods 3 4 Intended Use : Method for quantitation of milk in the context of food manufacturing. 5 6 1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to 7 be used during the evaluation of a method. The evaluation may be an on-site verification, a 8 single-laboratory validation, or a multi-site collaborative study. SMPRs are written and 9 adopted by AOAC Stakeholder Panels composed of representatives from the industry, 10 regulatory organizations, contract laboratories, test kit manufacturers, and academic 11 institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of 12 validation study data for method being considered for Performance Tested Methods or AOAC 13 Official Methods of Analysis SM , and can be used as acceptance criteria for verification at user 14 laboratories.

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2. Applicability:

Quantitation of milk in one or more food(s) such as those listed in Table 3 of Appendix M. 1

3. Analytical Technique :

Enzyme-linked immunosorbent assay (ELISA)-based assays.

4. Definitions :

Enzyme-linked immunosorbent assay (ELISA)

For the purposes of this document, ELISA is defined as “an analytical procedure characterized by the recognition and binding of specific antigens by antibodies”. This definition is not meant to be restrictive and encompasses other related binding based

technologies.

Limit of Detection (LOD)

LOD is defined as the lowest concentration or mass of analyte in a test sample that can be distinguished from a true blank sample at a specified probability level . 2

Limit of Quantitation (LOQ)

LOQ is the lowest level of analyte in a test sample that can be quantified at a specified level

of precision. 3

Repeatability

Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator (in the same laboratory) and repeating during a short time period.

Expressed as the repeatability standard deviation (SD r

); or % repeatability relative standard

deviation (%RSD r

). 4