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1. 发明申请

WO2012022774A1 AN ASSAY FOR MEASUREMENT OF ANTIBODIES BINDING TO A THERAPEUTIC MONOCLONAL ANTIBODY 审中-公开
标题翻译：用于测量抗体与治疗性单克隆抗体的测定方法
公开(公告)号：WO2012022774A1
公开(公告)日：2012-02-23
申请号：PCT/EP2011/064178
申请日：2011-08-17
申请人： ROCHE DIAGNOSTICS GMBH , F. HOFFMANN-LA ROCHE AG , GRUNERT, Veit Peter , KLAUSE, Ursula , KUBALEC, Pavel , ROTHFUSS, Matthias , UPMEIER, Barbara
发明人： GRUNERT, Veit Peter , KLAUSE, Ursula , KUBALEC, Pavel , ROTHFUSS, Matthias , UPMEIER, Barbara
IPC分类号： G01N33/68
CPC分类号： G01N33/6854 , C40B30/04 , G01N2800/52
摘要： The invention relates to an immunoassay method for determination of an anti- antibody (anti- AB) in vitro in a sample from a patient treated with a therapeutic monoclonal antibody (TmAB). The method comprises the steps of (a) providing an F(ab) fragment of said TmAB bound to a solid phase, (b) incubating the solid phase provided in (a) with the sample, thereby binding the anti- AB to the solid phase via the F(ab) fragment, (c) incubating the solid phase obtained in (b) with a monoclonal antibody that binds to the anti- AB, (d) detecting the monoclonal antibody bound in (c) and thereby determining the anti- AB in the sample. The invention also concerns a method for the determination of antigen specific antibodies of a particular immunoglobulin class by means of an immunoassay in an array format in which the detection of an anti- AB to a TmAB in a sample provided from a patient treated with said TmAB is determined in vitro. Also disclosed is the use of such method for detection of an anti- antibody and in the identification of a patient who is at risk to develop an adverse drug reaction (ADR) during treatment with a TmAB.
摘要翻译：本发明涉及在用治疗性单克隆抗体（TmAB）治疗的患者的样品中体外测定抗<治疗性单克隆抗体>抗体（抗-TABAB> AB）的免疫测定方法。该方法包括以下步骤：（a）提供与固相结合的所述TmAB的F（ab）片段，（b）将（a）中提供的固相与样品孵育，由此结合抗-TABAB 通过F（ab）片段与固相反应，（c）将（b）中获得的固相与结合抗-ABA的单克隆抗体一起培养，（d）检测结合于（c ），从而确定样品中的抗-TABAB> AB。本发明还涉及通过免疫测定以阵列形式测定特定免疫球蛋白类别的抗原特异性抗体的方法，其中从患者治疗的样品中检测到样品中的抗-TABAB至TmAB 所述TmAB在体外测定。还公开了使用这种用于检测抗-TTAB>抗体的方法以及在用TmAB治疗期间处于发展不良药物反应（ADR）的风险的患者的鉴定中。

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