Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves.
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(microg/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 microg/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 microg/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 microg/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.
Palosuo
T
T
Laboratory of Immunobiology, National Public Health Institute, Helsinki, Finland.
Reinikka-Railo
H
H
Kautiainen
H
H
Alenius
H
H
Kalkkinen
N
N
Kulomaa
M
M
Reunala
T
T
Turjanmaa
K
K
D000485:Allergens / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D017575:Gloves, Protective / Q000009:adverse effects* / Q000592:standards*; D006801:Humans; D020315:Latex Hypersensitivity / Q000209:etiology*; D012882:Skin Tests
D000485:Allergens