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8.
Validation Guidance
:
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Method developers must provide data for method performance in all the claimed matrices.
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Method developers must provide recovery data using incurred samples for all claimed
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matrices.
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Add appropriate Appendix reference for PTM requirement (Appendix J).
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Appendix D :Guidelines for Collaborative Study Procedures To Validate Characteristics of a
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Method of Analysis
;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
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(2012). Available at:
http://www.eoma.aoac.org/app_d.pdf101
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Appendix F :Guidelines for Standard Method Performance Requirements; 19
th
Edition of the
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AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
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http://www.eoma.aoac.org/app_f.pdf105
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Appendix M :Validation Procedures for Quantitative Food Allergen ELISA Methods:
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Community Guidance and Best Practices; 19
th
Edition of the AOAC INTERNATIONAL Official
108
Methods of Analysis (2012). Available at:
http://www.eoma.aoac.org/app_m.pdf109
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Table 1: Method performance requirements (deleted wine section)
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Parameter
Minimum Acceptance Criteria for target matrix
Analytical Range (ppm)
≤ 5 - ≥ 10
LOQ (ppm)
≤5
LOD (ppm)
≤5
Recovery (%)*
50-150%
% RSD
r
≤20 %
% RSD
R
≤ 30%
Note:
ppm dried egg.
*Using incurred samples (acceptance criteria in Appendix M).
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