Journal List > Allergy Asthma Respir Dis > v.6(4) > 1099895

Allergy Asthma Respir Dis. 2018 Jul;6(4):191-196. Korean.
Published online July 30, 2018.  https://doi.org/10.4168/aard.2018.6.4.191
© 2018 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology
Allergen standardization
Jung-Won Park, and Kyoung Yong Jeong
Department of Internal Medicine and Allergy Institute, Yonsei University College of Medicine, Seoul, Korea.

Correspondence to: Jung-Won Park. Department of Internal Medicine and Allergy Institute, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. Tel: +82-2-2228-1961, Fax: +82-2-2227-7932, Email: parkjw@yuhs.ac
Received October 14, 2017; Revised October 27, 2017; Accepted November 08, 2017.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/).


Abstract

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.

Keywords: Allergen standardization; Allergen immunotherapy; Reference material

Tables


Table 1
Allergen potency units of available immunotherapy reagents in Korea
Click for larger imageClick for full tableDownload as Excel file


Table 2
List of standardized allergen extracts in United States
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Table 3
Available standardized allergen reference materials in Korea
Click for larger imageClick for full tableDownload as Excel file

Notes

This research was supported by a grant from the Korea Healthcare Technology R&D Project through Korean Health Industry Development Institute, which is funded by Republic of Korea's Ministry of Health, Welfare (HI14C1324).

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