Vailes L, Sridhara S, Cromwell O, Weber B, Breitenbach M, Chapman M
Asthma & Allergic Diseases Center, Box 801355, Department of Medicine, University of Virginia, Charlottesville, VA 22908-1355, USA.
J Allergy Clin Immunol. 2001 Apr;107(4):641-6. doi: 10.1067/mai.2001.114118.
Alternaria is one of the most important fungi associated with allergic disease, whereas Aspergillus fumigatus is involved in a broad spectrum of pulmonary diseases. Currently, fungal extracts used for diagnosis in the United States are unstandardized, and their allergenic content cannot be compared directly.
The goal of this study was to compare the variability of major allergen levels among US allergenic products derived from fungi: specifically, Alt a 1 levels in Alternaria alternata extracts, and Asp f 1 levels in A fumigatus extracts.
A novel 2-site monoclonal antibody ELISA was used for measuring Alt a 1 using recombinant Alt a 1 as a standard. Asp f 1 was also measured by ELISA. Allergenic products produced by 8 US manufacturers over a 2-year period were compared, as were multiple lots produced by a single company.
Alt a 1 levels in Alternaria extracts from 8 companies produced in 1998 and 1999 ranged from less than 0.01 to 6.09 microg/mL (mean 1.4 +/- 1.6 microg/mL, n = 15). In general, Alt a 1 levels were consistent within and between companies (1.4 +/- 1.1 microg/mL, n = 27), with 21 of 32 (66%) of all extracts tested containing 0.7 to 2 microg/mL Alt a 1. Aspergillus extracts showed much greater variability in Asp f 1 levels, with extracts from 8 companies containing from less than 0.1 to 64 microg/mL Asp f 1 (mean 16.3 +/- 23.9 microg/mL, n = 15). Overall variability was greater for Aspergillus products within and between manufacturers (22 +/- 22 microg/mL Asp f 1, n = 20).
ELISA-based assays for specific allergens showed greater consistency among allergenic products derived from Alternaria than from Aspergillus. These assays should facilitate improved quality control and standardization of fungal allergen extracts and lead to the development of more consistent products for clinical use.
链格孢属是与过敏性疾病相关的最重要真菌之一，而烟曲霉则涉及广泛的肺部疾病。目前，美国用于诊断的真菌提取物未标准化，其过敏原含量无法直接比较。
本研究的目的是比较美国真菌源性过敏原产品中主要过敏原水平的变异性：具体而言，是比较链格孢提取物中Alt a 1的水平以及烟曲霉提取物中Asp f 1的水平。
使用一种新型的双位点单克隆抗体ELISA，以重组Alt a 1为标准来测量Alt a 1。Asp f 1也通过ELISA进行测量。比较了8家美国制造商在两年内生产的过敏原产品，以及单个公司生产的多个批次产品。
1998年和1999年8家公司生产的链格孢提取物中Alt a 1水平范围为低于0.01至6.09微克/毫升（平均1.4±1.6微克/毫升，n = 15）。总体而言，公司内部和公司之间的Alt a 1水平较为一致（1.4±1.1微克/毫升，n = 27），所有测试提取物中有21份（66%）含有0.7至2微克/毫升的Alt a 1。烟曲霉提取物的Asp f 1水平显示出更大的变异性，8家公司的提取物中Asp f 1含量从低于0.1至64微克/毫升（平均16.3±23.9微克/毫升，n = 15）。制造商内部和制造商之间烟曲霉产品的总体变异性更大（22±22微克/毫升Asp f 1，n = 20）。
基于ELISA的特定过敏原检测显示，链格孢属过敏原产品之间的一致性高于烟曲霉属。这些检测应有助于改善真菌过敏原提取物的质量控制和标准化，并促进开发更一致的临床用产品。
