6533b853fe1ef96bd12ad48a

RESEARCH PRODUCT

Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves

subject

description

Background:  Assessment of allergenic potential of medical devices made of natural rubber latex (NRL) requires the measurement of concentrations of specific allergenic proteins or polypeptides eluting from rubber. Methods:  Four NRL allergens (Hev b 1, 3, 5, and 6.02) were quantified in all medical glove brands marketed in Finland in 1999, 2001, and 2003 (n = 208) by a capture enzyme immunoassay. The results were compared with those obtained from previous nationwide market surveys, using a skin prick test-validated human IgE-based ELISA-inhibition method. Results:  A high overall correlation (r = 0.87, 95% CI 0.83–0.90) emerged between the sum values of the four allergens(μg/g glove) and IgE-ELISA inhibition (allergen units, AU/ml, 1 : 5 diluted glove extract). The sum of four allergens when set at 0.15 μg/g discriminated ‘low allergenic’ (<10 AU/ml) from ‘moderate- to high-allergenic’ (≥10 AU/ml) gloves at a sensitivity of 0.93 (95% CI 0.85–0.98) and specificity of 0.90 (95% CI 0.83–0.94). When the sum was below the detection limit (0.03 μg/g) all gloves belonged to the previously defined low-allergen category. Conclusions:  By comparing the sum concentration of four selected NRL allergens with results obtained in human IgE-ELISA inhibition, it was possible set a cut-off level (0.15 μg/g) below which virtually all gloves contain low or insignificant amounts of allergens, and can be considered as low allergenic. At different cut-off-points, one could calculate the likelihood of a given glove to belong to the previously defined low, moderate or high allergen categories.