AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

DRAFT MilkAllergen SMPR Version 6; July 20, 2017

Tracked Changes

Quantitation of Milk by ELISA-based Methods

IntendedUse :Method forquantitationofmilk in the contextof foodmanufacturing.

1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics to be used during the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative study. SMPRsarewrittenandadoptedby AOACStakeholderPanels composedof representatives from the industry, regulatoryorganizations, contract laboratories, testkitmanufacturers,andacademic institutions. AOACSMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for method being considered for PerformanceTestedMethods orAOAC OfficialMethodsofAnalysis ,andcanbeusedasacceptancecriteria forverification atuser laboratories.

2. Applicability: Quantitationofmilk inoneormore food(s) suchas those listed inTable3ofAppendixM. 1

3. AnalyticalTechnique : Enzyme-linked immunosorbentassay (ELISA)-basedassays.

4. Definitions :

Enzyme-linked immunosorbentassay (ELISA) For thepurposesof thisdocument,ELISA isdefinedas “ananalyticalprocedure characterizedby the recognitionand bindingof specificantigensbyantibodies”.Thisdefinition is notmeant tobe restrictiveandencompassesother related bindingbased technologies. LimitofDetection (LOD) LOD isdefinedas the lowest concentrationormassofanalyte ina test sample that canbedistinguished froma true blank sampleata specifiedprobability level . 2 LimitofQuantitation (LOQ) LOQ is the lowest levelofanalyte ina test sample that canbe quantifiedata specified levelofprecision. 3 Repeatability Variationarisingwhenalleffortsaremade to keep conditions constantbyusing the same instrumentandoperator (in the same laboratory)and repeatingduringa short timeperiod.Expressedas the repeatability standarddeviation (SD r ); or% repeatability relative standarddeviation (%RSD r ). 4