Allergen standardization

Jung-Won Park; Kyoung Yong Jeong

doi:10.4168/aard.2018.6.4.191

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Park and Jeong: Allergen standardization

Review

Allergy Asthma Respir Dis 2018;6(4):191-196.

Published online: 5 July 2018

DOI: https://doi.org/10.4168/aard.2018.6.4.191

Allergen standardization

Jung-Won Park, Kyoung Yong Jeong

Department of Internal Medicine and Allergy Institute, Yonsei University College of Medicine, Seoul, Korea

Correspondence to: Jung-Won Park https://orcid.org/0000-0003-0249-8749 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, E-mail: parkjw@yuhs.ac

• 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).

Received 14 October 201727 October 2017 Accepted 8 November 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/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 man-ufacturing 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

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Table 1.

Allergen potency units of available immunotherapy reagents in Korea

Company	Allergen unit	Standardization
Stallergenes	Index of reactivity (IR)	Skin prick test
Lofarma	Diagnostic biological units	Skin prick test
Hollister-Stier	Bioequivalent allergen unit (BAU)	Intradermal skin test
Allergy therapeutics	Therapeutic unit (TU)	Skin prick test
	Diagnostic unit (DU)
Alk-Albero	Standardized quality units tablet (SQ)	Skin prick test
	Standard treatment unit (STU)
Allergopharma	Standard biological unit (SBE)	Skin prick test
	Therapeutic unit (TU)

Table 2.

List of standardized allerg en extracts in United State es

Allergen	Tests for allergen potency	Unit
Dermatophagoides pteronyssinus	ELISA inhibition	AU/mL
Dermatophagoides farinae
Cat pelt (Felis domesticus)	RID for Fel d 1 IEF	BAU/mL (equivalent
Cat hair (Felis domesticus)		to AU/mL)
Ambrosia artemisiifolia	RID for Amb a 1	Amb a 1 units
Bermuda grass	ELISA inhibition IEF	BAU/mL
Red top grass
Kenturcky blue grass
Perennial rye grass
Orchard grass
Timothy grass
Meadow fescue grass
Sweet vernal grass
Yellow hornet (Vespa species)	Hyaluronidase and	μg protein
Polistes species	phospholipase activity
Honey bee
White faced hornet (Vespa species)
Yellow jacket (Vespula species)
Mixed vespid (Vespa + Vespula)
ELISA, enzyme-linked immunosorben fusion; IEF, isoelectric focusing; BAU,	t assay; AU, allergy unit; RID biologic allergy unit.	D, radial immunodif-

Table 3.

Available standardized allergen reference materials in Korea

Allergen	Standardization method	Unit
Dermatophagoides pteronyssinus	ID skin test, ELISA inhibition	AU/mL
Dermatophagoides farinae	ID skin test, ELISA inhibition	AU/mL
Cat hair (Felis domesticus)	ID skin test, ELISA inhibition	AU/mL
Blattella germanica	ID skin test, ELISA inhibition	AU/mL
Mugwort (Artemisia vulgaris)	ID skin test, ELISA inhibition	AU/mL
Humulus japonicus	ID skin test, ELISA inhibition	AU/mL
Oak pollen (Quercus acutissima)	ID skin test, ELISA inhibition	AU/mL
Buckwheat (Fagopyrum esculentum)	Protein, ELISA inhibition	μg protein
Recombinant Pac c 3 (Pachycondyla chinensis)	Protein	μg protein
ID, intradermal; ELISA, enzyme-linked immunosorbent assay; AU, allergy unit.

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