ASTM D7427-16
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

Standard No.

ASTM D7427-16

Release Date

2016

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM D7427-16(2021)

Latest

ASTM D7427-16(2021)

Scope

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 ......

ASTM D7427-16 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water
• ASTM D4483 Standard Practice for Determining Precision for Test Method Standards in the Rubber and Carbon Black Industries
• ASTM D4678 Standard Practice for Rubber8212;Preparation, Testing, Acceptance, Documentation, and Use of Reference Materials
• ASTM D5712 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
• ASTM D6499 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products*， 2023-05-01 Update
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

ASTM D7427-16 history

• 2021 ASTM D7427-16(2021) 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
• 2016 ASTM D7427-16 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
• 2014 ASTM D7427-14 Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins &40;Hev b 1, 3, 5 and 6.02&41; in Natural Rubber and Its Products Derived from Latex
• 2008 ASTM D7427-08e2 Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products Derived from Latex
• 2008 ASTM D7427-08e1 Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products Derived from Latex
• 2008 ASTM D7427-08 Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products Derived from Latex