Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (omalizumab)
Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (omalizumab)
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DOI：
10.1016/j.jaci.2006.01.012
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发表时间：
2006-04-01
影响因子：
14.2
通讯作者：
Hamilton, RG
中科院分区：
文献类型：
--
作者：
Hamilton, RG
背景：虽然血清学IgE测量可以帮助评估哮喘患者使用omalizumab （Xolair [Genentech, Inc., South San Francisco, Calif .]；人源化IgG(1)抗人IgE Fc）的疗效，但其对临床使用的IgE测定性能的影响尚不清楚。目的：本研究调查了omalizumab给药后IgE: igg -抗IgE免疫复合物的形成降低了诊断免疫学实验室进行的IgE检测的准确性并增加了变异性的假设。方法：4例特应性成人血浆用omalizumab（50或200摩尔过量IgE）或缓冲液孵育。在美国病理学家诊断性过敏熟练度调查（周期SE-C-2003， SE-A-2005）中，配对标本被蒙住送往159个临床实验室。通过使用国家熟练度调查数据计算omalizumab对美国食品和药物管理局（FDA）批准的总IgE和过敏原特异性IgE测定的准确性和可重复性产生的抑制效应。结果：omalizumab的存在使2项ImmunoCAP试验中测定的血清总IgE水平有轻微降低（2.4-9.0%），而其他5项试验显示从12.5%到67.2%的显著降低(P
Background: Although serological IgE measurements can aid in efficacy assessment of patients with asthma on omalizumab (Xolair [Genentech, Inc., South San Francisco, Calif]; humanized IgG(1) antihuman IgE Fc), its effect on clinically used IgE assay performance is unknown.Objective: This study investigated the hypothesis that IgE:IgG-anti-IgE immune complex formation after omalizumab administration diminishes accuracy and increases variability of IgE assays performed in diagnostic immunology laboratories.Methods: Plasma from 4 atopic adults was incubated with omalizumab (50 or 200 molar excess to IgE) or buffer. Paired specimens were sent masked to 159 clinical laboratories in the College of American Pathologists Diagnostic Allergy Proficiency Survey (cycles SE-C-2003, SE-A-2005). Inhibitory effects produced by omalizumab on accuracy and reproducibility of US Food and Drug Administration (FDA)cleared total and allergen-specific IgE assays were computed by using national proficiency survey data.Results: Total serum IgE levels measured in the 2 ImmunoCAP assays were minimally reduced (2.4-9.0%) by the presence of omalizumab, whereas 5 other assays showed marked reductions from 12.5% to 67.2% (P