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8.
Validation Guidance
:
91
Method developers must provide data for method performance in all the claimed matrices.
92
93
Method developers must provide recovery data using incurred samples for all claimed
94
matrices.
95
96
Add appropriate Appendix reference for PTM requirement (Appendix J).
97
98
Appendix D :Guidelines for Collaborative Study Procedures To Validate Characteristics of a
99
Method of Analysis
;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
100
(2012). Available at:
http://www.eoma.aoac.org/app_d.pdf101
102
Appendix F :Guidelines for Standard Method Performance Requirements; 19
th
Edition of the
103
AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
104
http://www.eoma.aoac.org/app_f.pdf105
106
Appendix M :Validation Procedures for Quantitative Food Allergen ELISA Methods:
107
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
110
111
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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