Takai Toshiro, Okamoto Yoshitaka, Okubo Kimihiro, Nagata Makoto, Sakaguchi Masahiro, Fukutomi Yuma, Saito Akemi, Yasueda Hiroshi, Masuyama Keisuke
Task Force for House Dust Mite Allergen Standardization of the Committee for Allergens and Immunotherapy of the Japanese Society of Allergology; Atpoy (Allergy) Research Center, Juntendo University Graduate School of Medicine.
Task Force for House Dust Mite Allergen Standardization of the Committee for Allergens and Immunotherapy of the Japanese Society of Allergology; Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University.
Arerugi. 2014 Nov;63(9):1229-40.
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.
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 the competitive ELISA using a pooled serum, with sera obtained from 10 allergic patients. Concentrations 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.
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.
The task force determined the in vivo allergenic potency (100000 JAU/ml) and Der 1 content (38.5 μg/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 100000 JAU/ml if it contains 22.2-66.7 μg/ml of Der 1.
20世纪90年代，日本变态反应学会（JSA）对日本柳杉花粉变应原疫苗进行了标准化。在本研究中，JSA变应原与免疫治疗委员会屋尘螨（HDM）变应原标准化特别工作组报告了日本HDM变应原疫苗的标准化情况。
通过对51名血清特异性IgE对HDM变应原呈阳性的日本成年人进行皮内试验来测定体内变应原效力。使用来自10名过敏患者的混合血清，通过竞争性ELISA分析体外总IgE结合效力。通过夹心ELISA测定8种HDM变应原提取物中HDM第1组（Der 1）和第2组主要变应原的浓度。分析体外总IgE结合效力与主要变应原水平之间的相关性。
我们选择了一种JSA参考HDM提取物并测定了其体内变应原效力。体外总IgE结合效力与Der 1含量、第2组变应原含量及其总量显著相关，表明主要变应原含量的测定可作为替代体外试验。
特别工作组确定了JSA参考HDM提取物的体内变应原效力（100000 JAU/ml）和Der 1含量（38.5μg/ml），选择Der 1含量的测定作为替代体外试验，并决定如果制造商生产的HDM变应原提取物含有22.2 - 66.7μg/ml的Der 1，则可标记其效价为100000 JAU/ml。
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