Patent ID: 8227195

Claim:
A method for determining whether an antibody present in a sample is a specific anti-drug antibody or a not-specific anti-drug antibody with an immunoassay, said method comprising: a) providing a-i) a capture drug antibody, which is said drug antibody conjugated to a solid phase, a-ii) a tracer drug antibody, which is said drug antibody conjugated to a detectable label, b) contacting said capture drug antibody separately with b-i) said sample, b-ii) said sample, to which said drug antibody in monomeric form has been added b-iii) said sample, to which said drug antibody in oligomeric form has been added, b-iv) said sample, to which human immunoglobulin G in monomeric form has been added, b-v) said sample, to which human immunoglobulin G in oligomeric form has been added, c) determining an antibody present in said sample to be a specific anti-drug antibody by a positive immunoassay in b-i) and b-iv) and b-v) and a negative immunoassay in b-ii) and b-iii), or determining an antibody present in said sample to be a not-specific anti-drug antibody by a positive immunoassay in b-i) and b-ii) and b-iv) and a negative immunoassay in b-iii) and b-v).