Abstract

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.

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