ISPAM Food Allergens Co-Chair Meeting 12-1-17

89 90 91 92 93 94 95 96 97 98 99

8. Validation Guidance :

Method developers must provide data for method performance in all the claimed matrices. Must specify if samples used for validation are: incurred or spiked; processed (baked) or

unprocessed (raw).

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

matrices.

Appendix D: Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis; 20 th Edition of the Official Methods of Analysis SM of AOAC INTERNATIONAL (2016). Available at: http://www.eoma.aoac.org/app_d.pdf Appendix F: Guidelines for Standard Method Performance Requirements; 20th Edition of the Official Methods of Analysis SM of AOAC INTERNATIONAL (2016). Available at:

100 101 102 103 104 105 106 107 108 109 110

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

Analytical Range (ppm) 1

≥ 20 2

LOQ (ppm) 2

≤10

LOD (ppm) 2

≤10

50-150%

Recovery (%) 3

% RSD r

≤20%

% RSD

≤30%

R

Notes: 1 ppm in non-fat dried milk. 2 See “Choice of LOD / LOQ for Quantitation of Milk by ELISA-based Methods” memo for rationale for setting lower limit of range. 3 Use incurred samples as per Appendix M. Incurred materials can be obtained from MoniQA Association.