ASTM D 7427 - 16 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

Current edition approved June 1, 2016. Published July 2016. Originally approved in 2008. Last previous edition approved in 2014 as D7427 – 14. — 15 p.
This test method covers an immunological method known as an immunoenzymetric assay to quantify the amount of 4 principal Hevea brasiliensis [Hev b] allergenic proteins [Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02] in Hevea natural rubber and its products2 derived from latex using monoclonal antibodies specific for epitopes on these proteins. Since these assays quantify the levels of only 4 of the known 14 officially acknowledged allergens potentially present in Hevea natural rubber latex containing products, the sum of the four allergen levels shall be viewed as an indicator of the allergen burden and not as a measure of the total allergen content that can be released from the product.
For the purpose of this test method, the range of allergenic protein will be measured in terms of nanogram to microgram quantities per gram or unit surface area of a Hevea natural rubber containing product.
The test method is not designed to evaluate the potential of Hevea natural rubber containing materials to induce or elicit Type I (IgE-mediated) hypersensitivity reactions.