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Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves
Author(s) -
Palosuo T.,
ReinikkaRailo H.,
Kautiainen H.,
Alenius H.,
Kalkkinen N.,
Kulomaa M.,
Reunala T.,
Turjanmaa K.
Publication year - 2007
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.2007.01411.x
Subject(s) - allergen , allergy , immunoglobulin e , immunoassay , latex allergy , medicine , food allergens , immunology , toxicology , biology , antibody
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.