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US 12,436,148 B2Granted
Direct immunoassay measurement of autoantibodies
AssigneeSiemens Healthcare Diagnostics Inc.
InventorsJames Freeman, Mariah Arcuri, Cheryl Krumm, Eddine Merabet
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Abstract
Disclosed herein are immunoassays for detecting an antibody in a biological sample from a subject and/or diagnosing an autoimmune disease in a subject. The disclosed immunoassays use a single, direct step to assess the level of antibody in a biological sample from the subject by simultaneously binding the antibody to a capture antigen (e.g. an unlabeled antigen bound to a solid support) and a labeled antigen not bound to the solid support.
Claims9
A method of diagnosing an autoimmune thyroid disease in a subject, the method comprising:
- a) diluting a biological sample from the subject to form a diluted biological sample and incubating the diluted biological sample from the subject with:
- a solid support having an unlabeled thyroglobulin bound thereto, wherein the unlabeled thyroglobulin is specifically recognized by an anti-thyroglobulin autoantibody from the subject, wherein the solid support comprises a magnetic bead or a magnetic particle;
- and
- a chemiluminescent-labeled thyroglobulin comprising a chemiluminescent label bound to a thyroglobulin in at least a 10 times molar excess to the thyroglobulin, wherein the chemiluminescent-labeled thyroglobulin does not bind to the solid support and is specifically recognized by the anti-thyroglobulin autoantibody,
- wherein, in the presence of the anti-thyroglobulin autoantibody, a solid support/chemiluminescent-labeled thyroglobulin complex is formed;
- b) separating with a magnet the solid support/chemiluminescent-labeled thyroglobulin complex from the chemiluminescent-labeled thyroglobulin that is not bound by the anti-thyroglobulin autoantibody;
- and
- c) detecting the chemiluminescence level of the solid support/chemiluminescent-labeled thyroglobulin complex, wherein the solid support/chemiluminescent-labeled thyroglobulin complex comprises a chemiluminescent label comprising acridinium ester or an analog thereof,
- thereby diagnosing the subject with the autoimmune thyroid disease.
6 more elements
Dependencies are inferred from the claim text.