Allergy, Asthma & Respiratory Disease

  • 제6권4호
  • /
  • Pages.191-196
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  • 2018
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  • 2288-0402(pISSN)
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  • 2288-0410(eISSN)
대한천식알레르기학회 (The Korean Academy of Asthma, Allergy and Clinical Immunology)
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알레르겐 표준화

Allergen standardization

  • 박중원 (연세의대 내과학교실 및 연세 알레르기 연구소) ;
  • 정경용 (연세의대 내과학교실 및 연세 알레르기 연구소)
  • Park, Jung-Won (Department of Internal Medicine and Allergy Institute, Yonsei University College of Medicine) ;
  • Jeong, Kyoung Yong (Department of Internal Medicine and Allergy Institute, Yonsei University College of Medicine)
  • 투고 : 2017.10.14
  • 심사 : 2017.11.08
  • 발행 : 2018.07.31
⟨ 이전 논문 다음 논문 ⟩

초록

Allergen immunotherapy (AIT) and diagnostic tests are based on well qualified allergen extracts, which are derived from biologic organisms. The allergenicity of the extracts is markedly affected by the climate, soil, year of production, storage methods, and manufacturing processes. Thus, standardization is a crucial process to guarantee the clinical efficacy and safety of the treatment and diagnostic reagents in allergic diseases. There are 2 different standardization processes, one is In vivo and the other is in vitro standardization. In vivo standardization is done by skin prick or intradermal tests. For in vitro standardization, measurements of weight/volume and protein nitrogen units have been widely used since the early period of AIT. In the 1970s, immunological methods such as radial immunodiffusion, enzyme-linked immunosorbent assay (ELISA) inhibition test and basophil activation test were developed. Allergen potency measured by ELISA inhibition test reflects the potency measured by skin tests and has been widely used for quality control of batch-to-batch variation. Recently, standardizations focused on the major allergen content of extracts have developed. Standardization for major allergens requires reliable reference materials (RMs) made of recombinant allergens and 2-site ELISA kits. However, only a few reliable RM and 2-site ELISA kits are available. For the standardization process, allergen RMs are essential. The Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration provides 19 allergen RMs, and our research team also proved 9 RMs which are important in Korea. In conclusion, allergen standardization is an essential process for the development of reliable treatment and diagnostic reagents, and allergy specialist should be familiar with the concept of allergen standardization.

키워드

과제정보

연구 과제 주관 기관 : Korean Health Industry Development Institute

참고문헌

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