FIELD: medicine; immunology.
SUBSTANCE: present group of inventions relates to determining in a sample the presence of a drug antibody with suppressed effector function. That is ensured by incubating a sample containing a mammalian blood serum with a full-size human I Fc-gamma receptor or a fragment thereof binding to the Fc region, such that a complex is formed between the antibody to the drug on a human or humanised drug antibody with a suppressed effector function, present in the sample, and a human I Fc-gamma receptor or fragment thereof binding to the Fc region. Full-size human receptor I Fc-gamma or fragment thereof binding to the Fc region is conjugated with the detectable label, and the formed complex is determined by detecting the label.
EFFECT: this provides higher sensitivity of the immunoassay due to the developed scheme and selection of FcγRI as an immunoassay component.
17 cl, 13 dwg, 11 tbl, 12 ex
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