Patent ID: 8298769
Filing Date: 2012-10-30
Classification: A61K,A61P,C07K,G01N

Abstract:
1. A method of screening a sample of body fluid for TSH receptor autoantibodies wherein said sample is from a subject suspected of suffering from, susceptible to, having or recovering from autoimmune disease associated with an immune reaction to a TSH receptor, said method comprising: (a) contacting said sample with a polypeptide comprising a full length TSH receptor, so as to permit said polypeptide to bind with TSH receptor autoantibodies present in said sample; (b) contacting said sample with one or more monoclonal antibodies that binds TSH receptor and competes with said autoantibodies for binding to said polypeptide, wherein said one or more monoclonal antibodies is positive for thyroid stimulating activity at a concentration of 20 μg/ml in a cyclic AMP thyroid cell assay and positive for inhibition of TSH binding to TSH receptor at a concentration of 20 μg/ml, said one or more monoclonal antibodies being classified as positive for thyroid stimulating activity if the thyroid stimulating activity is greater than 180 percent in the cyclic AMP thyroid cell assay wherein said percent thyroid stimulation activity comprises 100×(ratio of cyclic AMP produced in the thyroid cell assay in the presence of said monoclonal antibody to cyclic AMP produced in the thyroid cell assay in the presence of sera pooled from healthy blood donors) and said one or more monoclonal antibodies being classified as positive for inhibition of TSH binding to TSH receptor if the inhibition of TSH binding to TSH receptor is greater than 10%; and (c) detecting binding of said polypeptide with said autoantibodies thereby providing an indication of the presence of said autoantibodies in said sample.