AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

DRAFT AOAC SMPR ® for Quantitation of Wheat, Rye and Barley Gluten in Oats; 1 Version 7, September 6, 2017 2 3 Intended Use : Quantitation of gluten in the context of food manufacturing. 4 5 1. Purpose: AOAC Standard Method Performance Requirements (SMPRs) describe the 6 minimum recommended performance characteristics to be used during the evaluation of a 7 method. The evaluation may be an on-site verification, a single-laboratory validation, or a 8 multi-site laboratory collaborative study. SMPRs are written and adopted by AOAC 9 Stakeholder Panels composed of representatives from the industry, regulatory organizations, 10 contract laboratories, test kit manufacturers, and academic institutions. AOAC SMPRs are 11 used by AOAC Expert Review Panels (ERPs) in their evaluation of validation study data for a 12 method (s) being considered to determine if they meet the requirements for Performance 13 Tested Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria 14 for verification at user laboratories.

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2. Applicability :

Quantitation of total wheat, rye & barley gluten in groats, rolled oats, steel cut oats, oat

flour, oat bran, and extruded/cooked/finished oat products.

3. Analytical Technique :

Enzyme-linked immunosorbent assay (ELISA) or related binding based technologies.

4. Definitions :

Gluten

Protein fraction from wheat, rye, barley or their crossbred varieties and derivatives thereof, to which some persons are intolerant and that is insoluble in water and 0.5 M NaCl.

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) 1

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) 1

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

of precision.

Repeatability 2

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.

1 Appendix M 2 ISO 5725-1