AOAC ISPAM Stakeholder Panel Meeting Book 3-13-18

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Reproducibility

Variation arising when identical test materials are analyzed in different laboratories 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 ). 4

Recovery

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

using the entire method.

Peanut

Peanut is a legume and classified as Arachis hypogaea. Peanut is usually consumed roasted, boiled or fried. For the purposes of this SMPR, peanut will be represented by NIST SRM

2387 (peanut butter).

Peanut butter is a food paste or spread made from ground dry roasted peanuts. It often contains additional seasoning and stabilizing ingredients that modify the taste or texture,

(Standard of Identity, 21 CFR 164.150 Peanut Butter)

• Method Performance Requirements :

See Table 1.

• 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 provide the conversion factor for peanut and total peanut

protein relative to NIST SRM 2387.

Method developers should provide applicability statement for intended use and claimed

matrices.

• Reference Material(s):

NIST Peanut Butter SRM 2387

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

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

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).

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

matrices.