Abstract

Objective Using recombinant TrxTSHRc protein which contains TSBAb antigen epitope as antigen, an enzyme linked immunosorbent assay (ELISA) was established. The cut-off of positive values of TSH receptor antibody (TRAb) was established. Methods Using recombinant TrxTSHRc protein as antigen, the optimum condition was determined, and the indirect ELISA for detecting TRAb (TRAb-C) in the serum of normal control subjects and thyroid disease patients was established. A total of 1 085 patients and healthy controls were tested for this antibody. Results TRAb-C ELISA mainly detected TSBAb. The A405((-x)±s) value in healthy group was 0. 319±0. 107 with a cut-off value ((-x)±2 s)of 0. 533. The positive rate in thyroid disease patients showed significant deviation, with 66. 01 % in patients with Hashimoto's thyroiditis, 41.68% in newly-diagnosed Graves'disease, 6.98% in simple goiter, 11.1% in subacute thyroiditis, 8.7% in nontoxic thyroid nodular goiter, and 3.2% in thyroid adenoma. Conclusion The TRAb-C ELISA mainly detects TSBAb, which is very valuable for autoimmune thyroid disease, especially for the diagnosis, prognosis and therapy evaluation in Hashimoto' s thyroiditis. Key words: Autoimmune thyroid disease; TRAb; TSBAb; ELISA

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