INTERFERENCE-SUPPRESSED IMMUNOASSAY TO DETECT ANTI-DRUG ANTIBODIES IN SERUM SAMPLES

摘要

Herein is reported an enzyme linked immunosorbent assay for the detection of anti-drug antibodies against a drug antibody in a sample comprising a capture drug antibody and a tracer drug antibody, wherein the capture drug antibody and the tracer drug antibody are employed in a concentration of 0.5 μg/ml or more, the sample is incubated simultaneously with the capture drug antibody and the tracer drug antibody for 1 to 24 hours, the capture drug antibody and the tracer drug antibody are derivatized via a single lysine residue, the sample comprises 10% serum, and oligomeric human IgG is added to the sample prior to the incubation with the capture drug antibody and the tracer drug antibody.

主权项

1. A method for the detection of anti-drug antibodies against a drug antibody in a sample of an rheumatoid arthritis patient comprising a capture drug antibody and a tracer drug antibody, wherein
a) the capture drug antibody and the tracer drug antibody have a concentration of 0.5 μg/ml or more, b) the sample is incubated simultaneously with the capture drug antibody and the tracer drug antibody for 0.5 to 24 hours, c) the capture drug antibody and the tracer drug antibody are each derivatized only once via a single lysine residue, d) the sample comprises 1% serum/plasma or more, e) oligomeric human IgG is added to the sample prior to the incubation with the capture drug antibody and the tracer drug antibody, and f) monomeric biotin and digoxygenin on capture and tracer.