Designation:D6499−12StandardTestMethodforTheImmunologicalMeasurementofAntigenicProteininNaturalRubberanditsProducts1ThisstandardisissuedunderthefixeddesignationD6499;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversanimmunologicalmethodtodeterminetheamountofantigenicproteininnaturalrubberanditsproductsusingrabbitantiseraspecificfornaturalrubberlatex(NRL)proteins.Thisimmunoassayprocedurequantita-tivelymeasuresthelevelofantigeniclatexproteinsinsolutionusinganinhibitionformat.Thesamplesmayincludegloveorotherrubberproductextractswhichhavebeencollectedinordertomeasurethelatexproteinlevels.Althoughthismethoddetectsantigenicproteins,itshouldnotbeconsideredasameasureofallergenicproteins.Correlationofprotein/antigenlevelswiththelevelofallergenicproteinshasnotbeenfullyestablished.1.2Forthepurposeofthistestmethod,therangeofproteinwillbemeasuredintermsofmicrogramtomilligramquanti-ties.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D4483PracticeforEvaluatingPrecisionforTestMethodStandardsintheRubberandCarbonBlackManufacturingIndustriesD5712TestMethodforAnalysisofAqueousExtractableProteininNaturalRubberandItsProductsUsingtheModifiedLowryMethodE691PracticeforConductinganInterlaboratoryStudytoDeterminethePrecisionofaTestMethod3.Terminology3.1Definitions:3.1.1allergens,n—proteinantigenswhichinduceallergicimmunereactionstypicallymediatedthroughIgEantibodies.3.1.2antibody,n—animmunoglobulin,aproteinthatisproducedasapartoftheimmuneresponsewhichiscapableofspecificallycombiningwiththeantigen.3.1.3antigen,n—anysubstanc...
