ASTM_D_7427_-_16.pdf

Designation:D742716Standard Test Method forImmunological Measurement of Four Principal AllergenicProteins(Hev b 1,3,5 and 6.02)in Hevea Natural Rubberand Its Products Derived from Latex1This standard is issued under the fixed designation D7427;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers an immunological methodknown as an immunoenzymetric assay to quantify the amountof 4 principal Hevea brasiliensis Hev b allergenic proteinsHev b 1,Hev b 3,Hev b 5 and Hev b 6.02 in Hevea naturalrubber and its products2derived from latex using monoclonalantibodies specific for epitopes on these proteins.Since theseassays quantify the levels of only 4 of the known 14 officiallyacknowledged allergens potentially present in Hevea naturalrubber latex containing products,the sum of the four allergenlevels shall be viewed as an indicator of the allergen burdenand not as a measure of the total allergen content that can bereleased from the product.1.2 For the purpose of this test method,the range ofallergenic protein will be measured in terms of nanogram tomicrogram quantities per gram or unit surface area of a Heveanatural rubber containing product.1.3 The test method is not designed to evaluate the potentialof Hevea natural rubber containing materials to induce or elicitType I(IgE-mediated)hypersensitivity reactions.1.4 This test method should be used under controlledlaboratory conditions to detect and quantify the level of 4allergenic proteins found in Hevea natural rubber containingproducts.It should not be used to describe,appraise or assessthe hazard or risk of these Hevea natural rubber containingmaterials or products under actual in use conditions.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D1193 Specification for Reagent WaterD4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustriesD4678 PracticeforRubberPreparation,Testing,Acceptance,Documentation,and Use of Reference Mate-rialsD5712 Test Method for Analysis of Aqueous ExtractableProtein in Latex,Natural Rubber,and Elastomeric Prod-ucts Using the Modified Lowry MethodD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its ProductsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3.Terminology3.1 Definitions:3.1.1 accepted reference value(ARV)value that serves asan agreed upon reference for comparison and which is derivedas(1)a theoretical or established value,based on scientificprinciples,(2)an assigned or certified value,based on experi-mental work of some national or international organization,or(3)a consensus or certified value,based on collaborativeexperimental work under the auspices of a scientific orengineering group.3.1.1.1 DiscussionARV is an average industrial referencematerial(IRM)property or parameter value established by wayof a specified test program.In this standard,theARV as definedin the IRMs for the reference antigens and capture anddetection antibodies is determined by analyzing a high and low1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved June 1,2016.Published July 2016.Originally approvedin 2008.Last previous edition approved in 2014 as D7427 14.DOI:10.1520/D7427-16.2This procedure has not been validated for condoms,particularly lubricatedcondoms,which could contain surfactants or other ingredients that could interferewith the assay.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 control in an inter-laboratory study and using the assignedvalues of these high and low controls to verify that the assay isin control and that the reagents are performing properly.3.1.2 accuracythe closeness of agreement between a testresult and an accepted reference value.3.1.3 allergensprotein antigens which induce allergic im-mune reactions typically mediated through IgE antibodies.3.1.4 analyteany element,ion,compound,substance,f