1.1 本试验方法包括一种免疫学方法，使用HNRL蛋白特异性兔血清测定橡胶树天然橡胶及其产品中抗原蛋白的含量。该免疫测定程序使用抑制形式定量测量溶液中抗原胶乳蛋白的水平。样品可以包括手套或其他产品提取物，这些提取物是为了测量HNR水平而收集的。尽管这种方法可以检测抗原蛋白，但不应将其视为致敏蛋白的测量方法。蛋白质/抗原水平与致敏蛋白质水平的相关性尚未完全确定。 1.2 就本试验方法而言，蛋白质的范围将以微克至毫克的量进行测量。 1.3 该测试方法可用于确定测试项目上HNR蛋白污染的存在和数量。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 1型乳胶过敏最常见的表现为皮肤与天然橡胶接触后的局部荨麻疹，但也可能包括过敏性鼻结膜炎、哮喘和罕见过敏反应的症状。这种直接（I型）过敏是由橡胶树固有的HNRL蛋白引起的，这些蛋白保留在成品上。使用标准比色蛋白质测定法对HNRL产品中的蛋白质水平进行定量可能会由于乳胶配方中的化学添加剂干扰测定而产生虚假结果 ( 2. , 3. ) 此外，在HNRL产品中发现的蛋白质的量通常低于标准比色蛋白质测定的检测极限 ( 4. , 5. ) . 5.2 该试验方法描述了使用兔抗HNRL血清定量HNRL蛋白的免疫学方法。用HNRL蛋白免疫的兔子对大多数存在的蛋白质产生反应，并且它们的血清能够检测HNRL中的大多数（如果不是全部的话）蛋白质。因此，尽管兔子抗体与抗原物质发生反应，但这不应被视为总蛋白质水平的定量测量。

1.1 This test method covers an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other product extracts which have been collected in order to measure the HNR levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established. 1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities. 1.3 This test method can be used to determine the presence and amount of HNR protein contamination on test items. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 Type 1 latex allergy most commonly manifests as localized urticaria after contact of skin with natural rubber but can also include symptoms of allergic rhinoconjunctivitis, asthma and rarely anaphylaxis. This immediate (Type I) allergy is caused by HNRL proteins inherent to the rubber tree, which remain on the finished products. The quantification of protein levels in HNRL products using the standard colorimetric protein assays may give spurious results due to chemical additives in the latex formulations that interfere with the assay ( 2 , 3 ) . Furthermore, the amount of protein found in HNRL products are often below the detection limits of the standard colorimetric protein assay ( 4 , 5 ) . 5.2 This test method describes an immunological method for quantitation of HNRL proteins using rabbit anti-HNRL serum. Rabbits immunized with HNRL proteins react to the majority of the proteins present, and their sera have the capability to detect most if not all of the proteins in HNRL. Therefore, although rabbit antibody reacts with antigenic material, this should not be considered as quantitative measure of total protein levels.