چکیده (انگلیسی):

Background: In the 1990s, the Japanese Society of Allergology (JSA) standardized Japanese cedar pollen
allergen vaccines. In the present study, the task force for house dust mite (HDM) allergen standardization
of the Committee for Allergens and Immunotherapy of JSA reports the standardization of HDM allergen
vaccines in Japan.
Methods: In vivo allergenic potency was determined by intradermal testing of 51 Japanese adults with
positive serum specific IgE to HDM allergens. In vitro total IgE binding potency was analyzed by
competition ELISA using a pooled serum, with sera obtained from 10 allergic patients. The amounts of
HDM group 1 (Der 1) and group 2 major allergens in eight HDM allergen extracts were measured by
sandwich ELISAs. Correlation between the in vitro total IgE binding potency and major allergen levels was
analyzed.
Results: We selected a JSA reference HDM extract and determined its in vivo allergenic potency. The
in vitro total IgE binding potency significantly correlated with Der 1 content, group 2 allergen content,
and their combined amount, indicating that measurement of major allergen contents can be used as a
surrogate in vitro assay.
Conclusions: The task force determined the in vivo allergenic potency (100,000 JAU/ml) and Der 1
content (38.5 mg/ml) of the JSA reference HDM extract, selected the measurement of Der 1 content as the
surrogate in vitro assay, and decided that manufacturers can label a HDM allergen extract as having a titer
of 100,000 JAU/ml if it contains 22.2e66.7 mg/ml of Der 1.