ISPAM Stakeholder Panel Meeting Book 3-14-17

DRAFT AOAC Allergen SMPR Version 6; March 13, 2017 1 2 3 Quantitation of Chicken Egg by ELISA-based* Methods 4 5 Intended Use : Method for quantitation of chicken egg in the context of food manufacturing. 6 7 1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to 8 be used during the evaluation of a method. The evaluation may be an on-site verification, a 9 single-laboratory validation, or a multi-site collaborative study. SMPRs are written and 10 adopted by AOAC Stakeholder Panels composed of representatives from the industry, 11 regulatory organizations, contract laboratories, test kit manufacturers, and academic 12 institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of 13 validation study data for method being considered for Performance Tested Methods or AOAC 14 Official Methods of Analysis , and can be used as acceptance criteria for verification at user 15 laboratories.

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2. Applicability :

Quantitation of chicken egg in one or more food(s) such as those listed in OMA Appendix M

(see Table 3). Add Journal reference

3. Analytical Technique :

Enzyme-linked immunosorbent assay (ELISA)-based assays (see definition in section 4).

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” 1 . This definition is not meant to be restrictive and encompasses other related binding based

technologies.

Limit of Detection (LOD) (reference Appendix M)

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 .

Limit of Quantitation (LOQ) (reference Appendix M)

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

of precision.

Limit of Application (LLA) (reference Appendix M)

A level below which the method developer does not support or recommend use of the

method.

1 AOAC Appendix M *See section 4 – Definitions - Enzyme-linked immunosorbent assay (ELISA)