ISPAM Stakeholder Panel Meeting Book 3-14-17

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Chicken Egg

• NIST 8445 (Spray dried whole egg for allergen detection)

9.8. Validation Guidance :

Method developers should must provide data for method performance in all the claimed

99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120

matrixesmatrices.

Method developers must provide recovery data using incurred samples for all claimed

matrices.

Add appropriate Appendix reference for PTM requirement (Appendix J)

Appendix D : Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of Analysis ; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis

(2012). Available at: http://www.eoma.aoac.org/app_d.pdf

Appendix F : Guidelines for Standard Method Performance Requirements; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). 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; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at: http://www.eoma.aoac.org/app_m.pdf

Table 1: Method performance requirements (deleted wine section)

Minimum Acceptance Criteria for target matrix Cookies, Bread, Dough, Salad Dressing

Parameter

Analytical Range (ppm)

≤< 5 - ≥> 10

LOQ (ppm)

≤5

LOD (ppm)

≤5

50-150%

Recovery (%)*

% RSD r

≤20 %