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DRAFT AOAC Allergen SMPR Version 2; November 30, 2016
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Quantitation of Whole
Chicken
Egg Allergens by ELISA-based Methods
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Intended Use
:
Reference mM
ethod for cGMP compliance.
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1.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics
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to be used during the evaluation of a method. The evaluation may be an on-site
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verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are
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written and adopted by AOAC Stakeholder Panels composed of representatives from the
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industry, regulatory organizations, contract laboratories, test kit manufacturers, and
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academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their
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evaluation of validation study data for method being considered for
Performance Tested
13
Methods
or AOAC
Official Methods of Analysis
, and can be used as acceptance criteria for
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verification at user laboratories.
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2.
Applicability
:
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Quantitation of whole
chicken
egg allergens in selected finished food products and
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ingredients as listed in table 2
(may need to revise table to be consistent with OMA
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Appendix M)
.
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3.
Analytical Technique
:
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Enzyme-linked immunosorbent assay (ELISA)
based assays or other binding based
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technologies
.
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4.
Definitions
:
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Enzyme-linked immunosorbent assay (ELISA)
based assays
.
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An assay that uses antibodies and color change to identify a substance. ELISA can perform
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other forms o
f ligand binding assays instead of strictly "immuno" assays, though the name
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carried the original "immuno" because of the common use and history of development of
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this method. The technique essentially requires any ligating reagent that can be immobilized
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on the solid phase along with a detection reagent that will bind specifically and use an
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enzyme to generate a signal that can be properly quantified.
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Binding Based Technology
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Allergens
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Commodities
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Limit of Quantitation (LOQ)
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The minimum concentration or mass of analyte in a given matrix that can be reported as a
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quantitative result.
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Formatted:
Numbering: Continuous
Comment [D1]:
May want to consider adding
environmental samples