| abstract |
METHOD FOR DETECTING THE PRESENCE OF NEUTRALIZING ANTIBODIES, E, KIT. An immunogenicity assay to detect the presence of neutralizing antibodies to a biotherapeutic protein, in which the biotherapeutic protein was administered to a patient in need, comprising the steps of (a) obtaining a sample from the patient; (B) incubate the sample in the presence of a capture reagent; and (c) adding a detection reagent, in which a decreased signal relative to a control sample indicates the presence of a neutralizing antibody to the biotherapeutic agent. |