ISPAM Food Allergens Working Group Co-Chair Meeting 12-1-17

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Appendix M: Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices; 20 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2016). Available at: http://www.eoma.aoac.org/app_m.pdf

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Table 1: Method performance requirements

Parameter

Minimum Acceptance Criteria for target matrix

Lower limit Upper limit

≤5

Analytical Range (ppm) 1

≥10

LOQ (ppm) 2

≤5

LOD (ppm) 2

≤5

50-150%

Recovery (%) 3

% RSD r

≤20 %

% RSD

≤ 30%

R

Notes:

1 ppm dried egg. 2 See “Choice of LOD / LOQ for Quantitation of Chicken Egg by ELISA-based Methods” (http:\www.aoac.org\xxyyzz) for rationale for setting lower limit of range. 3 Using incurred samples (acceptance criteria in Appendix M).

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1. Appendix M: Validation Procedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices, Official Methods of Analysis (2016) 20 th Ed., AOAC INTERNATIONAL, Rockville, MD, www.eoma.aoac.org; and, Journal of AOAC INTERNATIONAL [ 93 (2) 442-450] (2010). 2. Ibid. 3. Ibid. 4. ISO 5725-1:1994 5 I bid. 6. Introduction to Egg Products, USDA Food Safety and Inspection Service, website:

http://www.fsis.usda. gov/wps/wcm/connect/c5c85914-5055-4f09-8098- 1a179a1c6e14/EPT_Introduction.pdf?MOD=AJPERES, accessed 12/15/2015.