Patent ID: 8530176

Claim:
A method for determining whether an anti-drug antibody in a sample is of monomeric or oligomeric form with an immunoassay, wherein the method comprises the following steps: 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) contacting said capture drug antibody contacted with said sample in step b) separately with said tracer drug antibody, wherein c-i) the capture drug antibody contacted with said sample in step b-i) is contacted with said tracer drug antibody and determining the detectable label, c-ii) the capture drug antibody contacted with said sample in step b-ii) is contacted with said tracer drug antibody and determining the detectable label, c-iii) the capture drug antibody contacted with said sample in step b-iii) is contacted with said tracer drug antibody and determining the detectable label, c-iv) the capture drug antibody contacted with said sample in step b-iv) is contacted with said tracer drug antibody and determining the detectable label, c-v) the capture drug antibody contacted with said sample in step b-v) is contacted with said tracer drug antibody and determining the detectable label, d) determining the anti-drug antibody in the sample to be of monomeric form by a positive immunoassay in c-i) and α) a negative immunoassay in c-ii) and c-iii), or β) a negative immunoassay in c-ii), c-iii), c-iv) and c-v), or determining an anti-drug antibody in the sample to be of oligomeric form by a positive immunoassay in c-i) and α) a negative immunoassay in c-iii), or β) a negative immunoassay in c-iii) or c-v).