ARDL’s ISO 17025 and ISO 13485 accredited microbiological testing laboratory offers a variety of testing, including latex protein analysis of products such as gloves (medical, household, food service, etc.), protective clothing, bandages, and condoms. 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 or life threatening allergic reaction. ASTM has developed a set of standards for quantifying extractable and antigenic proteins, both of which ARDL’s microbiological laboratory is accredited by A2LA to perform.
The ASTM D5712 Modified Lowry Standard is a chemical method used to quantify the total extractable protein content of a test item. This method is not specific to latex proteins, but will tell you the total amount of extractable protein from Hevea and other sources that are in the test item. This assay defines one sample as three items (e.g., gloves). ARDL is also accredited for BS EN 455-3, the European Standard equivalent of ASTM D5712. The BS EN 455-3 procedure defines one sample as four individual test items.
The ASTM D6499 Inhibition ELISA 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.
ARDL’s microbiological testing laboratory has further expanded ARDL’s accredited testing capabilities on personal protective equipment (PPE). The laboratory offers testing to evaluate the performance of materials including ASTM F1670 blood penetration/resistance testing, ASTM F1671/F1671M viral penetration/resistance testing, the European equivalent ISO 16604 viral penetration/resistance testing, and ISO 10993-5 cytotoxicity testing. The microbiological testing laboratory offers the full suite of A2LA accredited testing for ANSI/AAMI PB70 classification of protective apparel and drapes intended for use in health care facilities: AATCC 42, AATCC 127, ASTM F1670/F1670M, and ASTM F1671/F1671M.
