Determining the presence of auto-antibodies to thyroid stimulating hormone receptors in biological samples using a receptor binding assay

摘要

Determining the presence of auto-antibodies (AAb) to thyroid stimulating hormone (TSH) receptor (TSHR) in a biological sample, using a receptor binding assay, is characterized by the use of a functional recombinant TSHR (rTSHR) as TSHR composition. Determining the presence of auto-antibodies (AAb) to thyroid stimulating hormone (TSH) receptor (TSHR) in a biological sample, using a receptor binding assay, is characterized by the use of a functional recombinant TSHR (rTSHR) as TSHR composition. Recombinant TSHR is bound via a selective antibody (anti-TSHR-Ab) to TSHR to a solid phase. The bound rTSHR is purified by washing and then transferred to an affinity-purified immobilized rTSHR (rTSHR(imm)). The biological sample is reacted with: (i) a TSHR composition and (ii) a labeled bovine TSH (bTSH). The presence of Aab is determined by the amount of bound, labeled bTSH in from the fluid phase-separated complex from bTSH, especially TSHR-Aab with TSHR. Independent claims are also included for : (1) a reagent kit comprising the ingredients described above; and (2) the use of a low-molecular fraction of human serum or its derivatives, two-valent metal ions and/or sulfate group comprising polysaccharides, for increasing the binding of TSH to a TSHR in a receptor binding assay.