AOAC ISPAM Food Allergens Assays 12-2017

47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97

Reproducibility

Variation arising when identical test materials are analyzed in different laboratory by different operators on different instruments. The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility standard

deviation (SD R

); or % reproducibility relative standard deviation (% RSD R ). 5

Recovery

The fraction or percentage of analyte that is recovered when the test sample is analyzed

using the entire method.

Egg

A combination of [chicken] egg whites and egg yolks in their entirety, in natural proportions. 6 For the purposes of this SMPR, egg is referred to in its dry form as represented

by existing reference materials

5. Method Performance Requirements :

See table 1.

6. System suitability tests and/or analytical quality control:

See antibody information, cross reactivity, information on calibrators and information on matrices in section “Required Allergen-Specific Information to be Provided on the ELISA

Method” of Appendix M.

Method developers should clearly identify what component(s) of the egg they are measuring and provide the conversion factor used to equate to dried egg.

Method developers should provide applicability statement for intended use and claimed

matrices.

7. Reference Material(s):

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F: Guidelines for Standard Method Performance Requirements , 20 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2016). Available at:

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

Chicken Egg

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

8. Validation Guidance :

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

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 AOAC INTERNATIONAL Official Methods of Analysis

(2016). Available at: http://www.eoma.aoac.org/app_d.pdf

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

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