Abstract
Allergens are molecules with the capacity to elicit IgE responses in humans. When stimulated with allergens, most allergic patients respond with production of IgE specific for several proteins/allergens in the source material. The standardization of allergen extracts is essential in order to control variability and to achieve consistency and reproducibility in a clinical setting.
Because the IgE binding capacity of an allergen extract is related to the content of one or a few major allergens, it is important that the standardization procedure ensures consistency, not only in the overall IgE binding potency, but also in the content and ratio of individual major allergens. Owing to the complexity of allergen extracts, a key element in standardization of allergen extracts is the use of standards.
This chapter describes the principles for standardization of allergen extracts to be used by research laboratories. Other chapters in this volume describe in vitro methods in detail.
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References
King TP, Hoffman D, Løwenstein H et al (1994) Allergen nomenclature. WHO/IUIS Allergen Nomenclature Subcommittee. Int Arch Allergy Immunol 105:224–233
Løwenstein H (1987) Selection of reference preparation. IUIS reference preparation criteria. Arb Paul Ehrlich Inst 80:75–78
European Directorate for the Quality of Medicines and HealthCare. Monograph on Allergen Products, European Pharmacopoeia 01/2010:1063
Wahn U, Schweter C, Lind P, Løwenstein H (1988) Prospective study on immunologic changes induced by two different Dermatophagoides pteronyssinus extracts prepared from whole mite culture and mite bodies. J Allergy Clin Immunol 82:360–370
Lindgren S, Belin L, Dreborg S, Einarsson R, Pahlman I (1988) Breed-specific dog-dandruff allergens. J Allergy Clin Immunol 82:196–204
Uhlin T, Reuterby J, Einarsson R (1984) Antigenic/allergenic composition of poodle/Alsatian dandruff extract. Allergy 39:125–133
Steringer I, Aukrust L, Einarsson R (1987) Variability of antigenicity/allergenicity in different strains of Alternaria alternata. Int Arch Allergy Appl Immunol 84:190–197
Wallenbeck I, Aukrust L, Einarsson R (1984) Antigenic variability of different strains of Aspergillus fumigatus. Int Arch Allergy Appl Immunol 73:166–172
Lemanske RF, Taylor SL (1987) Standardized extracts, foods. Clin Rev Allergy 5:23–36
Dreborg S, Foucard T (1983) Allergy to apple, carrot and potato in children with birch pollen allergy. Allergy 38:167–172
Verstege A, Mehl A, Rolinck-Werninghaus C et al (2005) The predictive value of the skin prick test weal size for the outcome of oral food challenges. Clin Exp Allergy 35:1220–1226
Davies DR, Padlan EA, Sheriff S (1990) Antibody–antigen complexes. Annu Rev Biochem 59:439–473
Løwenstein H, Marsh DG (1981) Antigens of Ambrosia elatior (short ragweed) pollen. I. Crossed immunoelectrophoretic analyses. J Immunol 126:943–948
Marsh DG (1987) Differential rates of allergen release: an important consideration in the preparation of allergenic extracts. Arb Paul Ehrlich Inst 80:47–57
Løwenstein H (1980) Physico-chemical and immunochemical methods for the control of potency and quality of allergenic extracts. Arb Paul Ehrlich Inst 75:122–132
Einarsson R, Dreborg S (1987) Manufacturers’ criteria for in-house references. Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M 80:131–138
Løwenstein H (1994) Methods used to develop standards. Arb Paul Ehrlich Inst 87:49–57
Dreborg S (1993) Standardization of allergenic preparations by in vitro and in vivo methods. Allergy 48(Suppl 14):63–70
Nordic Council on Medicines (1989) Guidelines for registration and standardization of allergenic extracts. NLN Publication No 23, 1–48
Dreborg S, Basomba A, Belin L et al (1987) Biological equilibration of allergen preparations: methodological aspects and reproducibility. Clin Allergy 17:537–550
Dreborg S, Einarsson R (1992) The major allergen content of allergenic preparations reflect their biological activity. Allergy 47:418–423
Helm RM, Gauerke MB, Baer H et al (1984) Production and testing of an international reference standard of short ragweed pollen extract. J Allergy Clin Immunol 73:790–800
Gjesing B, Jäger L, Marsh DG, Løwenstein H (1985) The international collaborative study establishing the first international standard for timothy (Phleum pratense) grass pollen allergenic extract. J Allergy Clin Immunol 75:258–267
Ford A, Seagroatt V, Platts-Mills TAE, Løwenstein H (1985) A collaborative study on the first international standard of Dermatophagoides pteronyssinus (house dust mite) extract. J Allergy Clin Immunol 75:676–686
Arntzen FC, Wilhelmsen TW, Løwenstein H et al (1989) The international collaborative study on the first international standard of birch (Betula verrucosa) pollen extract. J Allergy Clin Immunol 83:66–82
Larsen JN, Ford A, Gjesing B et al (1988) The collaborative study of the international standard of dog, Canis domesticus, hair/dander extract. J Allergy Clin Immunol 82:318–330
Helm RM, Squillace DL, Yunginger JW, Members of the International Collaborative Trial (1988) Production of a proposed international reference standard Alternaria extract II. Results of a collaborative trial. J Allergy Clin Immunol 81:651–663
Baer H, Anderson MC, Helm RM et al (1986) The preparation and testing of the proposed international reference (IRP) Bermuda grass (Cynodon dactylon)-pollen extract. J Allergy Clin Immunol 78:624–631
Stewart GA, Turner KJ, Baldo BA et al (1988) Standardization of rye-grass pollen (Lolium perenne) extract. An immunochemical and physicochemical assessment of six candidate international reference preparations. Int Arch Allergy Appl Immunol 86:9–18
Aas K, Backman A, Belin L, Weeke B (1978) Standardization of allergen extracts with appropriate methods. The combined use of skin prick testing and radio-allergosorbent tests. Allergy 33:130–137
Turkeltaub PC (1987) Biological standardization based on quantitative skin testing - the ID50 EAL method (intradermal dilution for 50 mm sum of erythema diameters determines the allergy unit). Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M 80:169–173
van Ree R, Chapman MD, Ferreira F et al (2008) The CREATE project: development of certified reference materials for allergenic products and validation of methods for their quantification. Allergy 63:310–326
Løwenstein H (1978) Quantitative immunoelectrophoretic methods as a tool for the analysis and isolation of allergens. Prog Allergy 25:1
Laemmli UK (1970) Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 227:680–685
Kyhse-Andersen J (1984) Electroblotting of multiple gels: a simple apparatus without buffer tank for rapid transfer of proteins from polyacrylamide to nitrocellulose. J Biochem Biophys Methods 10:203–209
Brighton WD (1975) Profiles of allergen extract components by isoelectric focussing and radioimmunoassay. Dev Biol Stand 29:362–369
Engvall E, Perlmann P (1972) Enzyme-linked immunosorbent assay, ELISA. III. Quantitation of specific antibodies by enzyme-labelled anti-immunoglobulin in antigen-coated tubes. J Immunol 109:129–135
Ceska M, Eriksson R, Varga JM (1972) Radioimmunosorbent assay of allergens. J Allergy Clin Immunol 49:1–9
Larsen JN, Houghton CG, Vega ML, Løwenstein H (2014) Manufacturing and standardizing allergen extracts in Europe. In: Lockey RF, Ledford DK (eds) Allergens and allergen immunotherapy, 5th edn. CRC Press, New York, pp 289–305
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Larsen, J.N., Dreborg, S. (2019). Standardization of Allergen Extracts. In: Lympany, P., Jones, M. (eds) Allergy. Methods in Molecular Biology, vol 2020. Humana, New York, NY. https://doi.org/10.1007/978-1-4939-9591-2_5
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DOI: https://doi.org/10.1007/978-1-4939-9591-2_5
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