Anti-drug antibody assay
OwnerJudith GREENGARD, Mark RENZ +1inventors
InventorsJudith GREENGARD, Mark RENZ, Valerie THEOBALD
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Abstract
Provided is an immunoassay for detection of anti-drug antibodies (ADAs), such as anti-C1-Inhibitor antibodies (C1INH-ADA in a test sample. The immunoassay provides a means for testing the immunogenicity and efficacy of drug treatment protocols.
Claims23
An immunoassay for detection of anti-drug antibodies within a test sample comprising the steps of (i) providing a test sample with an acidic environment for dissociation of anti-drug antibodies from the drug within a test sample;
- (ii) neutralization of the test sample containing the dissociated drug-ADA complexes (iii) incubation of the sample with excess binding affinity-labeled drug;
- (iv) capture of the resulting ADA-affinity labeled drug complexes on an affinity binding substrate surface;
- (v) addition of tagged anti-human antibodies;
- and (vi) quantification of captured antibody-drug-ADA complexes.
An immunoassay for detection of anti-CIINH antibodies within a test sample comprising the steps of (i) providing a test sample with an acidic environment for the dissociation of C1INH-ADA complexes within the test sample;
- (ii) neutralization of the test sample containing the dissociated C1INH-ADA complexes;
- (iii) incubation of the test sample with excess binding affinity-labeled C1INH resulting in formation of binding affinity-labeled C1INH-ADA complexes;
- (iv) capture of the resulting binding affinity-labeled C1INH-ADA complexes within the test sample on a functionalized affinity binding substrate surface;
- (vi) addition of tagged anti-human antibodies that bind to the captured binding affinity-labeled C1INH-ADA complexes;
- and (v) quantification of captured binding affinity-labeled C1INH-ADA complexes.
A kit for determining the presence or absence of ADAs in a test sample said kit comprising (i) instructions and (ii) one or more reagents selected from the group consisting of an acid solution;
- a neutralization buffer, a binding affinity labeled drug;
- an affinity binding substrate for capture of ADA-binding affinity labeled drug complexes;
- and tagged anti-human antibodies.
Dependencies are inferred from the claim text.