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US 12,742,785 B2Granted
High ionic strength dissociation assay for high drug tolerant testing
AssigneeHoffmann-La Roche Inc.
InventorsGregor Jordan, Roland Staack
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Abstract
Herein is reported a method for the determination of the presence of anti-drug antibodies in a sample comprising the steps of incubating the sample with MgCl2 at a final concentration in the range of 1 N to 12 N; adding a tracer antibody and incubating the sample thereafter; incubating the isolated tracer antibody-anti-drug antibody-complexes with a detection antibody conjugated to a detectable label and determining the presence of anti-drug antibodies if a signal above a threshold level is obtained.
Claims14
A method for the detection of a target antibody in a sample comprising the following steps:
- a) incubating the sample with a chaotropic salt at a final cation charge normality in the range of 1 N to 12 N;
- b) adding a tracer antibody to the sample obtained in step a) and incubating the sample thereafter under conditions wherein the tracer antibody binds to either to a variable region or a constant region of the target antibody, thereby forming a tracer antibody-target antibody-complex in the presence of the chaotropic salt;
- c) incubating the tracer antibody-target antibody-complex formed in step b) with a detection antibody conjugated to a detectable label under conditions wherein the detection antibody binds to a variable region or a constant region of the tracer antibody in the tracer antibody-target antibody-complex, thereby forming a tracer antibody-target antibody-detection antibody complex;
- whereby the target antibody is detected if a tracer antibody-target antibody-detection antibody-complex is detected in the sample obtained in step c), wherein the chaotropic salt is MgCl2 or LiCl2, and wherein the method is enzyme-linked immunosorbent assay (ELISA).
1 more element
Dependencies are inferred from the claim text.