Method for In Vitro Quantifying Allo-Antibodies, Auto-Antibodies and/or Therapeutic Antibodies

摘要

An in vitro method for quantifying a target-specific test antibody in a test sample, comprising the steps of: a) performing an immunoassay using a target immobilized on a support which is brought into contact with the test sample, the immunoassay comprising a step of measuring the binding of the target-specific test antibody to the immobilized target by using a detectable non-antibody ligand that binds to the Fc region or to a light chain of an antibody, whereby a concentration-related value of the target-specific test antibody in the test sample is obtained, and b) comparing the concentration-related value obtained at step a) with a reference value obtained by performing an immunoassay using the target immobilized on a support which is brought into contact with a calibration sample comprising a known concentration of a target-specific calibration antibody, the immunoassay comprising a step of measuring the binding of the target-specific calibration antibody to the immobilized target by using the detectable non-antibody ligand of step a), and wherein: (i) the target-specific test antibody of step a) and the target-specific calibration antibody of step b) are identical, or (ii) the target-specific test antibody of step a) and the target-specific calibration antibody of step b) are distinct.

主权项

1. An in vitro method for quantifying a target-specific test antibody in a test sample, comprising the steps of:
a) performing an immunoassay using a target immobilized on a support which is brought into contact with the test sample, the immunoassay comprising a step of measuring the binding of the target-specific test antibody to the immobilized target by using a detectable non-antibody ligand that binds to the Fc region or a to light chain of an antibody, whereby a concentration-related value of the target-specific test antibody in the test sample is obtained, and b) comparing the concentration-related value obtained at step a) with a reference value obtained by performing an immunoassay using the target immobilized on a support which is brought into contact with a calibration sample comprising a known concentration of a target-specific calibration antibody, the immunoassay comprising a step of measuring the binding of the target-specific calibration antibody to the immobilized target by using the detectable non-antibody ligand of step a), and wherein: (i) the target-specific test antibody of step a) and the target-specific calibration antibody of step b) are identical, or (ii) the target-specific test antibody of step a) and the target-specific calibration antibody of step b) are distinct.