Immunological methods for quantifying free and total serum IgE levels in allergy patients receiving Omalizumab (Xolair) therapy
Immunological methods for quantifying free and total serum IgE levels in allergy patients receiving Omalizumab (Xolair) therapy
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DOI：
10.1016/j.jim.2005.06.008
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发表时间：
2005-08-01
影响因子：
2.2
通讯作者：
Saini, SS
中科院分区：
文献类型：
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作者：
Hamilton, RG;Marcotte, GV;Saini, SS
奥马珠单抗（人源化 IgG1 抗人 IgE Fc，Xolair (c)）与循环 IgE 复合，阻断 IgE 与肥大细胞和嗜碱性粒细胞上的高亲和力 epsilon Fc 受体 (Fc epsilon R1) 结合。血清中游离（非奥马珠单抗结合）IgE 水平是有效奥马珠单抗剂量的衡量标准。本研究的目的是量化服用 Xolair (R) 的哮喘患者的游离（非奥马珠单抗复合物）和总血清 IgE 水平。使用固相免疫酶测定法 (IEMA) 测量人血清中（非奥马珠单抗结合的）游离 IgE 的浓度，其中用单克隆抗人 IgE（克隆 HP6061）从血清中捕获 IgE，并用标记的 FceRla 进行检测。在配套的总人血清 IEMA 中，使用相同的抗人 IgE（克隆 HP6061）从血清中捕获 IgE，并使用标记的单克隆抗人 IgE Fc（克隆 HP6029）检测所有结合的 IgE。对 12 名过敏性哮喘患者的奥马珠单抗治疗前、治疗后 1 个月和 3 个月的血清中游离 IgE 和总 IgE 水平进行了定量。在没有奥马珠单抗的情况下，游离 IgE IEMA 和总 IgE IEMA 的工作范围相当（10-1000 kIU/I），具有出色的精度、重现性和平行性。 IEMA 测定的奥马珠单抗使用前总 IgE 水平和游离 IgE 水平高度相关 (r2=0.9(9)，Y=0.9X + 0.32，p
Omalizumab (humanized-IgG1 anti-human IgE Fc, Xolair (c)) complexes circulating IgE, blocking IgE binding to high affinity epsilon Fc receptors (Fc epsilon R1) on mast cells and basophils. Free (non-Omalizumab bound) IgE levels in serum are a measure of effective Omalizumab dosing. The goal of this study was to quantify free (non-Omalizumab-complexed) and total serum IgE levels in asthma patients on Xolair (R). The concentration of (non-Omalizumab bound) free IgE in human serum was measured using a solid phase immunoenzymetric assay (IEMA) in which IgE was captured from serum with monoclonal anti-human IgE (clone HP6061) and detected with labeled-FceRla. In a companion total human serum IEMA, IgE was captured from serum with the same anti-human IgE (clone HP6061) and all bound IgE was detected with labeled monoclonal anti-human IgE Fc (clone HP6029). Free and total IgE levels were quantified in pre- and 1 and 3 months post Omalizumab therapy sera from 12 allergic asthma patients. In the absence of Omalizumab, working ranges of the free and total IgE IEMAs were comparable (10-1000 kIU/I), with excellent precision, reproducibility and parallelism. Pre-Omalizumab total and free IgE levels by IEMA were highly correlated (r2=0.9(9), Y=0.9X + 0.32, p