Patent ID: 7015003

Claim:
A method for the determination of TSH receptor autoantibodies comprising: (i) reacting a solid phase, comprising an affinity-purified immobilized functional recombinant human TSH receptor, with a liquid biological sample to be assayed for the presence of said autoantibodies; (ii) separating a reacted solid phase from the liquid biological sample; (iii) washing the reacted solid phase; (iv) incubating the reacted solid phase with a buffer solution comprising an amount of labeled bovine TSH for a sufficient time to occupy all the TSH binding sites of the functional recombinant human TSH receptor not occupied by the autoantibodies; and (v) determining the presence and/or amount of the autoantibodies on the basis of the amount of labeled bovine TSH bound to the solid phase; wherein the functional recombinant human TSH receptor is immobilized to a solid support by a selective monoclonal antibody that recognizes only conformational epitopes of the human TSH receptor and is obtained by immunizing an animal with a DNA plasmid construct encoding the human TSH receptor and washed.