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Chapter 105 : Quantification and Standardization of Allergens

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Abstract:

This chapter talks about natural or recombinant proteins or glycoproteins used in the diagnosis and/or treatment of immunoglobulin E (IgE)-mediated allergic disease. The purpose of allergen standardization is to ensure that the extracts are well characterized in terms of allergen content and that variation between lots is minimized even among different manufacturers. In the United States, the use of a biological model of allergen standardization has permitted the assignment of bioequivalent allergen units (BAU) for most standardized allergens. Although skin testing is an essential component of the allergen standardization program, it is not intended for routine use in the testing of manufactured lots of extracts prior to release. For the Hymenoptera venom allergens, the potency determination is also based on the content of the known principal allergens within the extract, hyaluronidase and phospholipase, which is determined by enzyme activity. Individual allergens may be measured and detected by various approaches using monospecific antisera or antibodies. Assay designs using these antisera include the radial immunodiffusion (RID) assay, crossed immunoelectrophoresis/ crossed radioimmunoelectrophoresis (CIE/CRIE), and enzyme-linked immunosorbent assay (ELISA) variants (direct, two-site, and competition). Each of the assays utilizes monospecific antisera or antibodies to detect and quantify the specified allergen. The identity of an allergen extract may be verified by visualizing the separated allergen proteins on the basis of their size and isoelectric points.

Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105

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Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105
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Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105
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FIGURE 1

Sample calculation of D. Serial threefold dilutions of test material were injected, and the ΣE responses were plotted against the negative log dilutions. The D is determined from the best-fit line by using the formula D50 = (50 — intercept)/slope. The calculated D of 6.78 corresponds to a value of 3-() × 100,000 BAU/ml = 35.9 BAU/ml.

Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105
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FIGURE 2

— Hypothetical parallel line bioassay curves. (Left) The bioassay curves are parallel, and the difference of log dilutions resulting in the same diameters is constant at all diameters. The log RP of test sample B compared to reference A is represented by the difference. (Right) The curves are not parallel, and the differences vary with the strength of the reaction. Thus, the log RP of B′ compared to A cannot be calculated.

Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105
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FIGURE 3

Diameters are measured from the inner margins of the penned outline. Longest (A) plus midpoint orthogonal (B) diameters and summed diameters (A + B) are recorded.

Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105
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Tables

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TABLE 1

Allergenic extracts currently standardized in the United States

Citation: Devore N, Slater J. 2006. Quantification and Standardization of Allergens, p 937-947. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch105

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