AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

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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

100 101 102 103 104

Table 1: Method performance requirements

Parameter

Minimum Acceptance Criteria for target matrix

Analytical Range (ppm)

≤5 - ≥10

LOQ (ppm)

≤5

LOD (ppm)

≤5

50-150%

Recovery (%)*

% RSD r

≤20 %

% RSD

≤ 30%

R

Note: ppm dried egg. *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.