Positive results (123 percent or greater) are consistent with Graves disease but do not always correlate with the presence and severity of hyperthyroidism. Antibodies to the Thyroid Stimulating Hormone Receptor (TSHR) may be stimulating, blocking, or neutral. Stimulating antibodies mimic the action of TSH and cause hyperthyroidism (Graves disease). This test determines the net effect of all TSHR antibody types present in the serum specimen.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.