| 摘要 |
Method for detecting and/or measuring anti-drug antibodies against a protein, polypeptide or other compound or molecule that comprises at least one immunoglobulin variable domain with an exposed C-terminal region in a sample, said method, comprising at least the steps of: a) contacting said sample with a capturing agent that is immobilized on a support, wherein said capturing agent is or essentially consists of said protein, polypeptide or other compound or molecule, under conditions such that any anti-drug antibodies against said protein, polypeptide or other compound or molecule can bind to said capturing agent; b) (optionally) removing any components or constituents present in said sample that do not bind to the capturing agent; c) detecting or measuring any anti-drug antibodies that have bound to the capturing agent, by contacting the complex of the capturing agent and any captured anti-drug antibodies with a detection agent, under conditions such that said detection agent can bind to (the complex of the capturing agent and) any captured anti-drug antibodies, wherein either: x) said capturing agent is or essentially consists of: (i) said protein, polypeptide or other compound or molecule (immobilized on the solid support); and (ii) 1-5 amino acid residues that are linked to the exposed C-terminal end of the immunoglobulin variable domain with the exposed C-terminal region that is comprised within the protein, polypeptide or other compound or molecule; y) said detection agent is or essentially consists of: (i) said protein, polypeptide or other compound or molecule; (ii) a detectable tag or label bound to said protein, polypeptide or other compound or molecule (either directly or via a suitable linker) and (iii) 1-5 amino acid residues that are linked to the exposed C-terminal end of the immunoglobulin variable domain with the exposed C-terminal region that is comprised within the protein, polypeptide or other compound or molecule. |
