Universal assay for determining the amount of therapeutic monoclonal antibodies and their corresponding anti-drug antibodies in a sample

摘要

The present invention relates to kits and methods of parts for determining the presence and amount of one or more therapeutic monoclonal antibodies and / or therapeutic monoclonal antibody inhibitor drug antibodies in a biological sample comprising the sample, treatment Providing a first conjugate comprising a target for a monoclonal antibody and a first conjugate moiety and a second conjugate comprising a target for the therapeutic monoclonal antibody and a second conjugate moiety, and then a therapeutic monoclonal antibody drug And detecting a change in the spectrophotometric signal when a complex is formed between the first conjugate and the second conjugate.