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DRAFTAOACAllergenSMPRVersion5;March10,2016.
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DetectionandQuantitationofSelected
Food
Allergens
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IntendedUse
: Referencemethod for cGMP compliance.
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1. Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics
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to be used during the evaluation of a method. The evaluation may be an on-site
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verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are
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written and adopted by AOAC Stakeholder Panels composed of representatives from the
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industry, regulatory organizations, contract laboratories, test kit manufacturers, and
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academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their
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evaluation of validation study data for method being considered for
Performance Tested
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Methods
or AOAC
Official Methods of Analysis
, and can be used as acceptance criteria for
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verificationatuser laboratories.
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2. Applicability
:
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Detectionandquantitationofegg,milk,peanut,andhazelnut foodallergens in finished food
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productsand ingredients. Method(s) shalluniquely identifyeachallergen.
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3. AnalyticalTechnique
:
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Mass spectrometrybasedmethods.
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4. Definitions
:
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FoodAllergens
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Hazelnut
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Anyof thenutsderiving from speciesof thegenus
Corylus
,especially thenutsof the
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species
Corylusavellana
(the commonhazel tree).
It isalsoknownas cobnutor filbert
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nutaccording to species. For thepurposesof thisSMPR, includesboth rawand
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processednuts.
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Milk
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For thepurposesof thisSMPR
:
“milk” refers topasteurized
whole
cow’s
(
Bos
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Taurus)
.
milk
.,and shall containnot less than81/4percentmilk solidsnot fat andnot
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less than31/4percentmilkfat.
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Peanut
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The seedof the
Arachishypogaea
plant. For thepurposesof thisSMPR, includesboth
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rawand roastedpeanuts.
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CodeofFederalRegulations;Title21 -FoodandDrugs,§131.110. Other internationally
recognizeddefinitionmaybeapplied.
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WholeEgg
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A combinationofpasteurized
[
chicken
] (
Gallusgallusdomesticus
)
eggwhitesandegg
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yolks from the sameproductionbatchblended together in theirentirety, innatural
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proportions.
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LimitofQuantitation (LOQ)
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Theminimum concentrationormassofanalyte inagivenmatrix that canbe reportedasa
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quantitative result.
LOQ=average (blank)+10* s0 (blank).*
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Methoddetection limit (MDL)
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Methoddetection limit (MDL)
is theminimum concentrationofa substance than canbe
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measuredand reportedwith99% confidence that theanalyte concentration isgreater than
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zero. It isdetermined fromanalysisofa sample inagivenmatrix containing theanalyte.
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Theminimum concentrationofa substance that canbemeasured (detected)and reported
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with99%confidence that theanalyte concentration isgreater than zeroand isdetermined
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fromanalysisofa sample inagivenmatrix containing theanalyteusingat least two ion
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MS/MS transitions.
See4 (a)of40CFRPart136,AppendixB toPart136 -Definitionand
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Procedure for theDeterminationof theMethodDetection Limit-Revision.
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Repeatability
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Variationarisingwhenalleffortsaremade tokeep conditions constantbyusing the same
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instrumentandoperatorand repeatingduringa short timeperiod.Expressedas the
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repeatability standarddeviation (SD
r
);or% repeatability relative standarddeviation
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(%RSD
r
).
*
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Reproducibility
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The standarddeviationor relative standarddeviation calculated fromamong-laboratory
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data.Expressedas the reproducibility standarddeviation (SD
R
);or% reproducibility relative
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standarddeviation (%RSD
R
).
*
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Recovery
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The fractionorpercentageof spikedanalyte that is recoveredwhen the test sample is
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analyzedusing theentiremethod.
**
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5. MethodPerformanceRequirements
:
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See table1.
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79
2
Introduction toEggProducts,USDAFoodSafetyand InspectionService,website
:http://www.fsis.usda.
gov/wps/wcm/connect/c5c85914-5055-4f09-8098-1a179a1c6e14/EPT_Introduction.pdf?MOD=AJPERES,
accessed12/15/2015.
*
SeeTableA3 inAppendixF:
Guidelines forStandardMethodPerformanceRequirements
for
additionalguidance.
**See
Spiking method in
AppendixM in theOfficialMethodsofAnalysis.
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Volume II -Methods,MethodVerificationandValidationORA-LAB.5.4.5; DOCUMENTNO.: IV-02;
VERSIONNO.:1.7; Section2–Microbiology;EFFECTIVEDATE:10-01-03;REVISED:08-25-14;WEBSITE:
http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm,ACCESSED:Feb.22,16.
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40CFRPart136,AppendixB toPart136 -DefinitionandProcedure for theDeterminationof theMethod
Detection Limit-Revision
(link)
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