ASTM D7427-16
四倍体天然橡胶及其产品衍生的四种主要过敏原蛋白（Hev b 1,3,5和6.02）的免疫测定标准检测方法

Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex

被代替

标准号

ASTM D7427-16

发布

2016年

发布单位

美国材料与试验协会

替代标准

ASTM D7427-16(2021)

当前最新

ASTM D7427-16(2021)

 

 

引用标准

ASTM D1193 ASTM D4483 ASTM D4678 ASTM D5712 ASTM D6499 ASTM E691

适用范围

5.1 IgE-mediated allergic reactions to protein allergens in Hevea 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 Hevea 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, fourteen 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 Hevea 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 Hevea natural rubber latex products will require separate documentation and validation.

(A) PR = pathogenesis-related.

5.3.1 From the historical context, a number of assays have been developed to quantify the level of protein, antigen and allergen in Hevea natural rubber latex containing products (see Practices D4483 and D4678).

5.3.2 The modified Lowry assay for total protein, Test Method D5712, was the first assay of this type. It assesses the level of total protein as an indirect indicator of allergenicity of latex-containing products. This assay does not discriminate between the allergenic and non-allergenic proteins.

5.3.3 The second assay to be developed involved the use of human ......

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