Competitive ligand binding assay for detecting neutralizing antibodies

A immunogenicity assay for detecting the presence of neutralizing antibodies to a biotherapeutic protein wherein the biotherapeutic protein has been administered to a patient in need, comprising the steps of (a) obtaining a sample from the patient; (b) incubating the sample in the presence of a capture reagent; and (c) adding a detecting reagent, wherein a decreased signal relative to a control sample indicates the presence of a neutralizing antibody to the biotherapeutic agent. 用于检测针对生物治疗蛋白质的中和抗体的存在的免疫原性测定法，其中已向需要的患者施用生物治疗蛋白质，该测定包括以下步骤：(a)获得患者的样品；(b)在捕获试剂的存在下孵育样品；以及(c)加入检测试剂，其中相对于对照样品降低的信号指示针对生物治疗剂的中和抗体的存在。