ASTM D7427-2008e1 天然橡胶及其胶乳衍生物中4种主要过敏蛋白质(Hevb1,3,5和6.02)免疫学测量的试验方法
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【英文标准名称】:StandardTestMethodforImmunologicalMeasurementofFourPrincipalAllergenicProteins(Hevb1,3,5and6.02)inNaturalRubberandItsProductsDerivedfromLatex
【原文标准名称】:天然橡胶及其胶乳衍生物中4种主要过敏蛋白质(Hevb1,3,5和6.02)免疫学测量的试验方法
【标准号】:ASTMD7427-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:D11.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:过敏原
【英文主题词】:allergens;Heveabrasiliensis;IEMA;immunoenzymetricassay;naturalrubberlatex;proteins;Allergens;Naturalrubber(NR);Naturalrubber(NR)latex;Proteins
【摘要】:IgE-mediatedallergicreactionstoproteinallergensinnaturalrubberlatexderivedfromtheHeveabrasiliensistreeemergedinthe1990sasaconcernwithoccasionalallergicmanifestations.Symptomsencompassinghives,uriticaria,rhinitis,asthmaandanaphylaxishaveallbeenreportedinlatexallergicindividualsexposedtoproductsderivedfromnaturalrubberlatex.SincenosafelevelofHevealatexallergenexposureisknown,avoidanceistheprimarymodeoftreatinglatexallergy.Asaresultofinvestigationsconductedbymanyscientistsacrosstheworld,thirteenlatexallergenshavesofarbeenidentifiedandcategorizedbytheAllergenNomenclatureSub-CommitteeoftheInternationalUnionofImmunologicalSocieties(IUIS)asHevb1toHevb13(Table1)(seeSpecificationD1193).ReportedsensitizationratesfortheseallergenicHevbproteinsvaryamongthemanyreportsasaresultofdifferencesinthestudypopulations,IgEantibodyassaymethodsandthequalityoftheHevballergensusedascalibratorsandqualitycontrolreagentsintheanalysis.Moststudies,however,agreethatHevb1andHevb3areimportantallergensforindividuals(forexample,childrenwithspinabifida)whoareexposedthroughmucosalcontactasaresultofmultiplesurgeriesorlatexcatheteruseforanextendedperiodoftime.Additionally,investigatorsperformingsensitizationstudiesalsoagreethatHevb5andHevb6.02areimportantallergensthatmayelicitsensitizationingenetically-predisposedindividualswhoareexposedtonaturalrubberlatex(2-4).Onthebasisoftheseclinicalstudies,assaysforthesefourallergenicproteins(thatis,Hevb1,Hevb3,Hevb5andHevb6.02)havebeendevelopedandtheyarethusthesubjectofthisstandard.Adoptionofimmunoenzymetricassayreagentsandstandardproteinsneededtoquantifyotherlatexallergens(otherthanHevb1,3,5,and6.02)inextractsofnaturalrubberlatexproductswillrequireseparatedocumentationandvalidation.1.1Thistestmethodcoversanimmunologicalmethodknownasanimmunoenzymetricassaytoquantifytheamountof4principalHeveabrasiliensis[Hevb]allergenicproteins[Hevb1,Hevb3,Hevb5andHevb6.02]innaturalrubberanditsproductsderivedfromlatexusingmonoclonalantibodiesspecificforepitopesontheseproteins.Sincetheseassaysquantifythelevelsofonly4oftheknown13officiallyacknowledgedallergenspotentiallypresentinnaturalrubberlatexcontainingproducts,thesumofthefourallergenlevelsshallbeviewedasanindicatoroftheallergenburdenandnotasameasureofthetotalallergencontentthatcanbereleasedfromtheproduct.1.2Forthepurposeofthistestmethod,therangeofallergenicproteinwillbemeasuredintermsofnanogramtomicrogramquantitiespergramorunitsurfaceareaofanaturalrubbercontainingproduct.1.3ThetestmethodisnotdesignedtoevaluatethepotentialofnaturalrubbercontainingmaterialstoinduceorelicitTypeI(IgE-mediated)hypersensitivityreactions.1.4Thistestmethodshouldbeusedundercontrolledlaboratoryconditionstodetectandquantifythelevelof4allergenicproteinsfoundinnaturalrubbercontainingproducts.Itshouldnotbeusedtodescribe,appraiseorassessthehazardorriskofthesenaturalrubbercontainingmaterialsorproductsunderactualinuseconditions.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Iti......
【中国标准分类号】:B72
【国际标准分类号】:83_060
【页数】:16P.;A4
【正文语种】:英语
【原文标准名称】:天然橡胶及其胶乳衍生物中4种主要过敏蛋白质(Hevb1,3,5和6.02)免疫学测量的试验方法
【标准号】:ASTMD7427-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:D11.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:过敏原
【英文主题词】:allergens;Heveabrasiliensis;IEMA;immunoenzymetricassay;naturalrubberlatex;proteins;Allergens;Naturalrubber(NR);Naturalrubber(NR)latex;Proteins
【摘要】:IgE-mediatedallergicreactionstoproteinallergensinnaturalrubberlatexderivedfromtheHeveabrasiliensistreeemergedinthe1990sasaconcernwithoccasionalallergicmanifestations.Symptomsencompassinghives,uriticaria,rhinitis,asthmaandanaphylaxishaveallbeenreportedinlatexallergicindividualsexposedtoproductsderivedfromnaturalrubberlatex.SincenosafelevelofHevealatexallergenexposureisknown,avoidanceistheprimarymodeoftreatinglatexallergy.Asaresultofinvestigationsconductedbymanyscientistsacrosstheworld,thirteenlatexallergenshavesofarbeenidentifiedandcategorizedbytheAllergenNomenclatureSub-CommitteeoftheInternationalUnionofImmunologicalSocieties(IUIS)asHevb1toHevb13(Table1)(seeSpecificationD1193).ReportedsensitizationratesfortheseallergenicHevbproteinsvaryamongthemanyreportsasaresultofdifferencesinthestudypopulations,IgEantibodyassaymethodsandthequalityoftheHevballergensusedascalibratorsandqualitycontrolreagentsintheanalysis.Moststudies,however,agreethatHevb1andHevb3areimportantallergensforindividuals(forexample,childrenwithspinabifida)whoareexposedthroughmucosalcontactasaresultofmultiplesurgeriesorlatexcatheteruseforanextendedperiodoftime.Additionally,investigatorsperformingsensitizationstudiesalsoagreethatHevb5andHevb6.02areimportantallergensthatmayelicitsensitizationingenetically-predisposedindividualswhoareexposedtonaturalrubberlatex(2-4).Onthebasisoftheseclinicalstudies,assaysforthesefourallergenicproteins(thatis,Hevb1,Hevb3,Hevb5andHevb6.02)havebeendevelopedandtheyarethusthesubjectofthisstandard.Adoptionofimmunoenzymetricassayreagentsandstandardproteinsneededtoquantifyotherlatexallergens(otherthanHevb1,3,5,and6.02)inextractsofnaturalrubberlatexproductswillrequireseparatedocumentationandvalidation.1.1Thistestmethodcoversanimmunologicalmethodknownasanimmunoenzymetricassaytoquantifytheamountof4principalHeveabrasiliensis[Hevb]allergenicproteins[Hevb1,Hevb3,Hevb5andHevb6.02]innaturalrubberanditsproductsderivedfromlatexusingmonoclonalantibodiesspecificforepitopesontheseproteins.Sincetheseassaysquantifythelevelsofonly4oftheknown13officiallyacknowledgedallergenspotentiallypresentinnaturalrubberlatexcontainingproducts,thesumofthefourallergenlevelsshallbeviewedasanindicatoroftheallergenburdenandnotasameasureofthetotalallergencontentthatcanbereleasedfromtheproduct.1.2Forthepurposeofthistestmethod,therangeofallergenicproteinwillbemeasuredintermsofnanogramtomicrogramquantitiespergramorunitsurfaceareaofanaturalrubbercontainingproduct.1.3ThetestmethodisnotdesignedtoevaluatethepotentialofnaturalrubbercontainingmaterialstoinduceorelicitTypeI(IgE-mediated)hypersensitivityreactions.1.4Thistestmethodshouldbeusedundercontrolledlaboratoryconditionstodetectandquantifythelevelof4allergenicproteinsfoundinnaturalrubbercontainingproducts.Itshouldnotbeusedtodescribe,appraiseorassessthehazardorriskofthesenaturalrubbercontainingmaterialsorproductsunderactualinuseconditions.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Iti......
【中国标准分类号】:B72
【国际标准分类号】:83_060
【页数】:16P.;A4
【正文语种】:英语
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