AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)

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AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form

2016-12-08 16:42:42

Michael Farrow

Abbott Nutrition

12-08-2016

Section 3 Line 23: Strike "based assays" and include "with consideration of other ligand

binding technologies."

Section 4: Include definitions for (1)Allergen: A food or substance which may initiate an

antibody-mediated immune response in certain individuals despite the substance not

being otherwise harmful; (2) Antigen: Any substance that is recognized and bound by

antibodies; (3) Rewrite ELISA as follows: An assay that uses an immobilized solid

phase component, antigen-antibody interactions, and color change to identify a

substance. (Strike the rest); (4) Ligand-Binding Assay (definition to be determined); (5)

Include proposed LOD text and strike MDL; (6) Part per million (ppm): microgram of

detected food antigen per gram of protein.

Table 1: Analytical Range: 0.5-500 ppm; LOQ: 0.5 ppm; LOD: 0.1 ppm; Recovery: 60-

140%; Small r RSD: 15%

ALSO these values should be adjusted to the food matrices that are being considered

and should be adjusted for typical serving sizes. (Multiple tables may be necessary

especially with the inclusion of environmental samples)

Table 2: Adjust matrix types to general food categories: e.g. Baked Goods, Beverages

(Non-alcoholic and alcoholic), Environmental Samples; Meats and Processed Foods,

etc.

Include examples within each category.

Section 2 Line 18: Add environmental samples; This is vital as ELISA-based

quantitative technologies are often part of the method validations for qualitative

technologies such as lateral flow devices. It may be pertinent to validate cleaning

through demonstrating an X-fold reduction in the specific antigens used at a facility.

Surfaces with and without dilute cleaning solutions can be problematic matrices for

antibody-based assays.

Line 5: Would it be necessary to strike Reference from intended use section? Wouldn't

reference status be at the discretion of AOAC committees once a novel method is up

for review?

Question 7: Where would information on Cross-Reactivity be captured?