AOAC ISPAM Stakeholder Panel Meeting Book (August 26, 2018)

104 105 106 107 108 109 110 111 112 113

Appendix F: Guidelines for Standard Method Performance Requirements; 20th Edition of the Official Methods of Analysis SM of AOAC INTERNATIONAL (2016). Available at:

http://www.eoma.aoac.org/app_f.pdf

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

Table 1: Method performance requirements

Parameter

Minimum Acceptance Criteria for target matrix

Lower limit Upper limit

≤10 ≥10

Analytical Range (ppm) 1

LOQ (ppm) 2

≤10

LOD (ppm) 2

≤10

50-150%

Recovery (%) 3

% RSD r

≤20%

% RSD

≤30%

R

Notes: 1 ppm in peanut. 2 See “Choice of LOD/LOQ for Quantitation of peanut by ELISA-Based Methods”

for rationale for setting lower limit of range. 3 Use incurred samples as per Appendix M.

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1. ISO 5725-1:1994 2. Ibid. 3. Ibid. 4 Ibid.