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
ASTM D7427-16 发布历史
ASTM D7427-16由美国材料与试验协会 US-ASTM 发布于 2016-06-01。
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的最新版本是哪一版？
最新版本是 ASTM D7427-16(2021) 。
ASTM D7427-16 发布之时，引用了标准
- ASTM D1193 试剂水(联邦试验方法No.7916)
- ASTM D4483 橡胶和炭黑工业中试验方法标准精确度测定的标准实施规程
- ASTM D4678 橡胶的标准实施规程.标准物质的制备、试验、验收、文献工作和使用
- ASTM D5712 用改进的Lowry法分析天然橡胶及其制品中可水提取蛋白质的标准试验方法
- ASTM D6499 橡胶树天然橡胶（HNR）及其制品中抗原蛋白免疫测定的标准试验方法*， 2023-05-01 更新
- ASTM E691 为测定试验方法精密度开展的实验室间的研究
* 在 ASTM D7427-16 发布之后有更新，请注意新发布标准的变化。
ASTM D7427-16的历代版本如下：
- 2021年 ASTM D7427-16(2021) 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
- 2016年 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
- 2014年 ASTM D7427-14 天然橡胶乳胶和气衍生产品中国四种主要致敏免疫蛋白 (Hev b 1, 3, 5和6.02) 测量的标准试验方法
- 2008年 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
- 2008年 ASTM D7427-08e1 天然橡胶及其胶乳衍生物中4种主要过敏蛋白质(Hev b 1, 3, 5和 6.02)免疫学测量的试验方法
- 2008年 ASTM D7427-08 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
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 ......
- 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