Materials and methods for detection of insulin dependent diabetes
AssigneesThe United States of America, as represented by the Secretary, Department of Health and Human Services, University of Florida
InventorsNoel K. Maclaren, Abner L. Notkins, Michael S. Lan
Life of this patent
Estimating the term…
Abstract
The method and compositions of this invention provide an effective and reliable substitute for the currently employed ICA assay for diabetes. By providing a method for detecting autoantibodies to both GAD65 and IA-2 auto-antigens, the method provides a chemical assay which has improved reliability. In addition, these antigens may be employed in therapeutic regimens aimed at achieving immune tolerance and therefore amelioration of the clinical condition.
Claims11
A method for detecting insulin dependent diabetes or susceptibility to developing insulin dependent (type 1) diabetes in a patient, which comprises contacting an antibody-containing patient sample with a combination of IA-2 and GAD65, and detecting the presence of antibodies in the serum of said patient which bind to a combination of IA-2 and GAD65, wherein the presence of said antibodies is indicative of the presence of immune mediated (type 1) diabetes or the susceptibility to developing immune mediated (type 1) diabetes in said patient compared to patients lacking antibodies that bind to IA-2 and GAD65.
A composition comprising both an isolated GAD65 and an isolated IA-2 molecule.
A kit for detection of autoantibodies associated with diabetes which comprises IA-2 protein or the intracellular domain of the IA-2 protein and wherein said kit further comprises GAD65 protein, antigenic peptides thereof, or antibodies to GAD65.
Dependencies are inferred from the claim text.