AOAC ISPAM Food Allergens Assays 12-2017
98 99
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” 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.
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