Research Report RR:D11-1098
Objective: This study evaluates the performance characteristics (precision, bias, linearity) of immunoenzymetric assays that are designed to quantify 4 major Hevea brasiliensis (Hev b) allergens (Hev b 1, 3, 5 and 6.02) in latex extracts under field use conditions by following American Society of Testing Materials (ASTM) protocols.Methods: Quantification of latex allergens in 56 latex glove extracts was performed by 6 laboratories using two-site immunoenzymetric assays and reagents (capture and detection antibodies, standards and controls) provided by one commercial source. Ten glove extracts were analyzed for each of four Hev b allergen concentrations on multiple days to evaluate assay precision and bias and 4 extracts were analyzed at multiple dilutions to evaluate assay linearity (parallelism). Data was collated and analyzed at two coordinating sites.
D7427-14 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
Committee D11 on Rubber
Subcommittee D11.40 on Consumer Rubber Products