【国外标准】 Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins

5.1 NRL derived from Hevea contains over 200 proteins a number of which are allergens capable of eliciting Type 1 anaphylactic reactions. Guayule Natural Rubber derived from the Parthenium argentatum plant contains many fewer proteins and at much lower levels than Hevea NRL. While there have been no reports of allergic reactions to GNR proteins at present, they have been shown to induce antibody production in exposed individuals.4 An immunological assay that tests for the presence of GNR has the advantage of providing the specificity and sensitivity that other ASTM standards such as Test Methods D5712 and D6499 do not offer.5.2 This test method describes an immunological method for the quantitation of Guayule natural rubber proteins using rabbit anti-GNR serum. Rabbits immunized with GNR 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 GNR. This test method may be used to determine if a test item contains material derived from a natural source.1.1 This test method covers an immunological method to determine the amount of protein in Guayule Natural Rubber (GNR) and its products using rabbit antisera specific for Guayule Natural Rubber latex proteins. This immunoassay procedure quantitatively measures the level of GNR proteins in solution using an inhibition format. The samples may include but are not restricted to, gloves or other GNR product extracts, and liquid GNR samples which have been collected in order to measure the protein levels.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 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.1.4 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.