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DRAFT AOAC Allergen SMPR Version 6; March 13, 2017
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Quantitation of Chicken Egg by ELISA-based* Methods
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Intended Use
: Method for quantitation of chicken egg in the context of food manufacturing.
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1.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics to
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be used during the evaluation of a method. The evaluation may be an on-site verification, a
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single-laboratory validation, or a multi-site collaborative study. SMPRs are written and
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adopted by AOAC Stakeholder Panels composed of representatives from the industry,
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regulatory organizations, contract laboratories, test kit manufacturers, and academic
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institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of
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validation study data for method being considered for
Performance Tested Methods
or AOAC
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Official Methods of Analysis
, and can be used as acceptance criteria for verification at user
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laboratories.
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2.
Applicability
:
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Quantitation of chicken egg in one or more food(s) such as those listed in OMA Appendix M
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(see Table 3). Add Journal reference
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3.
Analytical Technique
:
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Enzyme-linked immunosorbent assay (ELISA)-based assays (see definition in section 4).
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4.
Definitions
:
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Enzyme-linked immunosorbent assay (ELISA)
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For the purposes of this document, ELISA is defined as “an analytical procedure
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characterized by the recognition and binding of specific antigens by antibodies”
1. This
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definition is not meant to be restrictive and encompasses other related binding based
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technologies.
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Limit of Detection (LOD) (reference Appendix M)
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LOD is defined as the lowest concentration or mass of analyte in a test sample that can be
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distinguished from a true blank sample at a specified probability level
.
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Limit of Quantitation (LOQ) (reference Appendix M)
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LOQ is the lowest level of analyte in a test sample that can be quantified at a specified level
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of precision.
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Limit of Application (LLA) (reference Appendix M)
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A level below which the method developer does not support or recommend use of the
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method.
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AOAC Appendix M
*See section 4 – Definitions - Enzyme-linked immunosorbent assay (ELISA)