Designation:D7427−16(Reapproved2021)StandardTestMethodforImmunologicalMeasurementofFourPrincipalAllergenicProteins(Hevb1,3,5and6.02)inHeveaNaturalRubberandItsProductsDerivedfromLatex1ThisstandardisissuedunderthefixeddesignationD7427;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversanimmunologicalmethodknownasanimmunoenzymetricassaytoquantifytheamountof4principalHeveabrasiliensis[Hevb]allergenicproteins[Hevb1,Hevb3,Hevb5andHevb6.02]inHeveanaturalrubberanditsproducts2derivedfromlatexusingmonoclonalantibodiesspecificforepitopesontheseproteins.Sincetheseassaysquantifythelevelsofonly4oftheknown14officiallyacknowledgedallergenspotentiallypresentinHeveanaturalrubberlatexcontainingproducts,thesumofthefourallergenlevelsshallbeviewedasanindicatoroftheallergenburdenandnotasameasureofthetotalallergencontentthatcanbereleasedfromtheproduct.1.2Forthepurposeofthistestmethod,therangeofallergenicproteinwillbemeasuredintermsofnanogramtomicrogramquantitiespergramorunitsurfaceareaofaHeveanaturalrubbercontainingproduct.1.3ThetestmethodisnotdesignedtoevaluatethepotentialofHeveanaturalrubbercontainingmaterialstoinduceorelicitTypeI(IgE-mediated)hypersensitivityreactions.1.4Thistestmethodshouldbeusedundercontrolledlaboratoryconditionstodetectandquantifythelevelof4allergenicproteinsfoundinHeveanaturalrubbercontainingproducts.Itshouldnotbeusedtodescribe,appraiseorassessthehazardorriskoftheseHeveanaturalrubbercontainingmaterialsorproductsunderactualinuseconditions.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpractices...
