ASTM D7427-08e2由美国材料与试验协会 US-ASTM 发布于 2008。
ASTM D7427-08e2 在中国标准分类中归属于: G40 橡胶制品综合。
ASTM D7427-08e2 天然橡胶和其乳胶衍生产品中四种主要致敏蛋白质 (Hev b 1, 3, 5和6. 02) 免疫学测量的标准试验方法的最新版本是哪一版？
最新版本是 ASTM D7427-16(2021) 。
5.1 IgE-mediated allergic reactions to protein allergens in natural rubber latex derived from the Hevea brasiliensis tree emerged in the 1990s as a concern with occasional allergic manifestations. Symptoms encompassing hives, uriticaria, rhinitis, asthma and anaphylaxis have all been reported in latex allergic individuals exposed to products derived from natural rubber latex.
5.2 Since no safe level of Hevea latex allergen exposure is known, avoidance is the primary mode of treating latex allergy.
5.3 As a result of investigations conducted by many scientists across the world, thirteen latex allergens have so far been identified and categorized by the Allergen Nomenclature Sub-Committee of the International Union of Immunological Societies (IUIS) as Hev b 1 to Hev b 13 (Table 1) (see Specification D1193). Reported sensitization rates for these allergenic Hev b proteins vary among the many reports as a result of differences in the study populations, IgE antibody assay methods and the quality of the Hev b allergens used as calibrators and quality control reagents in the analysis. Most studies, however, agree that Hev b 1 and Hev b 3 are important allergens for individuals (for example, children with spina bifida) who are exposed through mucosal contact as a result of multiple surgeries or latex catheter use for an extended period of time. Additionally, investigators performing sensitization studies also agree that Hev b 5 and Hev b 6.02 are important allergens that may elicit sensitization in genetically-predisposed individuals who are exposed to natural rubber latex (2-4). On the basis of these clinical studies, assays for these four allergenic proteins (that is, Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02) have been developed and they are thus the subject of this standard. Adoption of immunoenzymetric assay reagents and standard proteins needed to quantify other latex allergens (other than Hev b 1, 3, 5, and 6.02) in extracts of natural rubber latex products will require separate documentation and validation.
TABLE 1 Characterized Latex AllergensNote 1—Hev b 1, 3, 5. and 6.02 have been set in boldface because these are the allergenic proteins that are quantified by the immunoenzymetic assays covered in this standard.Name
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