Latex Protein Analysis

ARDL offers Latex Protein Analysis of latex products including PPE, (personal protective equipment), condoms, fitness equipment, healthcare on various first aid items and so on. 

Natural Rubber Latex (NRL) obtained from the Hevea tree contains many naturally occurring proteins.  Residual proteins on products can be absorbed by the user and in some cases produce a severe life threatening allergic reaction.  ASTM has developed a set of standards for quantifying these proteins and ARDL is accredited by A2LA for all three of these standards.

ASTM D5712

ASTM D5712 - (Modified Lowry Assay) is a chemical method used to quantify the total extractable protein content of a test item.  This method is not specific for latex proteins but will determine the total amount of protein from Hevea brasiliensis and other sources that are present on the test item.  NOTE that for this assay,  a minimum three items (e.g., gloves) are required for a single test result.  ARDL is also accredited for CEN455-3, which is the European Standard equivalent of the ASTM D5712.  NOTE: For the CEN procedure, at least 4 gloves are required for testing.

ASTM D6499

ASTM D6499 - (Inhibition ELISA Assay) is an immunological method which uses antibodies raised to the full complement of Hevea proteins to quantify the amount of Hevea proteins present. This method is specific for Hevea proteins and will not quantify other proteins if present.

These two methods constitute the basis of the natural latex allergy product evaluation and are conducted within ARDL’s Microbiologyical laboratory scope.  The laboratory focuses on latex protein testing and biocompatibility assays and further expands ARDL’s capabilities in the microbiological field. 

ASTM D7427

ASTM D7427 - (Allergen ELISA Assay) is a test method that uses a set of four ELISA kits that quantifies four of the most common Hevea allergens. The assay is a Sandwich ELISA, which uses monoclonal antibody pairs to bind and quantify the specific allergen levels. These 4 allergens serve as a proxy for the total complement of allergens. This assay is more specific than the D6499 assay in that it measures a subset of the total antigenic proteins - the allergens.