Patent ID: 8865417

Claim:
A method for detecting the presence or level of an autoantibody to an anti-TNFα drug in a sample, the method comprising: (a) contacting a labeled anti-TNFα drug and labeled TNFα with the sample to form a first labeled complex between the labeled anti-TNFα drug, the labeled TNFα, and the autoantibody and a second labeled complex between the labeled anti-TNFα drug and the autoantibody, wherein the labeled anti-TNFα drug and the labeled TNFα comprise different labels; (b) subjecting the first labeled complex and the second labeled complex to size exclusion chromatography to separate the first labeled complex and the second labeled complex; and (c) detecting the first labeled complex and the second labeled complex, thereby detecting the presence or level of a non-neutralizing form of the autoantibody when both the first labeled complex and the second labeled complex are present, and detecting the presence or level of a neutralizing form of the autoantibody when only the second labeled complex is present.