Patent ID: 8501415
Filing Date: 2013-08-06
Classification: C07K,G01N

Abstract:
1. A method for determining the amount of thyroid stimulating hormone (TSH) receptor autoantibodies in a human serum or plasma sample comprising: a) contacting said human serum or plasma sample with a functional TSH receptor (TSHr) that is immobilized on a solid support in the presence of labeled autoantibodies against the TSH receptor for a time sufficient for the autoantibodies in said human or plasma sample to competitively bind to the TSH receptor; b) removing unbound labeled TSH receptor autoantibodies; and c) determining the amount of TSH receptor autoantibodies in the human serum or plasma sample by measuring the amount of labeled autoantibodies bound to the TSH receptor, wherein the labeled autoantibodies against the TSH receptor are polyclonal human autoantibodies from a pool of sera from human Graves' disease patients that are affinity purified using a recombinant human TSH receptor that is immobilized to a solid support by a selective monoclonal antibody that: (i) recognizes a conformational epitope of the functional human TSH receptor; (ii) does not bind to peptides representing short sequences of human TSH receptor but binds strongly to complete functional recombinant human TSH receptor; and (iii) is obtained by immunizing an animal with a DNA construct that encodes the human TSH receptor.