Assay for measurement of antibodies binding to a therapeutic monoclonal antibody

摘要

Methods and system for determination of an anti- antibody (anti-AB) in vitro in a sample from a patient treated with a therapeutic monoclonal antibody (TmAB). Also, methods and systems for the determination of antigen specific antibodies of a particular immunoglobulin class and for the identification of a patient who is at risk of developing an adverse drug reaction (ADR) during treatment with a TmAB.

主权项

1. A method for determination of an anti- antibody (antiAB) in a whole blood, serum and plasma sample from a patient treated with a therapeutic monoclonal antibody (TmAB), the method comprising:
a) providing a F(ab) fragment of the TmAB bound to a solid phase; b) incubating the solid phase provided in (a) with the sample, thereby binding the anti AB to the solid phase via the F(ab) fragment; c) incubating the solid phase obtained in (b) with a monoclonal antibody , whereby said monoclonal antibody binds to the antiAB, wherein said monoclonal antibody is an IgM antibody having a dissociation constant (=KD) value of about 10−6 mol/l-10−8 mol/l; and d) detecting the monoclonal antibody bound in (c) and thereby determining the antiAB in the sample.