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Thyroid-stimulating hormone (TSH) is a pituitary hormone that regulates thyroid function in conjunction with thyrotropin-releasing hormone (TRH). Specifically, TSH induces production of Thyroxine (T4) which is converted triiodothyronine (T3) and is responsible for stimulating the metabolism. TSH is secreted throughout life but reaches high levels during the periods of rapid growth and development, as well as in response to stress.
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TSH is produced by the pituitary gland and its main role is to control the production of the thyroid hormones, thyroxine (T4) and triiodothyronine (T3). When T3 and T4 concentrations are low, the production of TSH is increased, and, conversely, when T3 and T4 concentrations are high, TSH production is decreased. Any imbalance in this negative feedback loop can be the indication of a thyroid disease, such as hyperthyroidism or hypothyroidism.
The most common cause of hypo- and hyperthyroidism are autoimmune diseases such as Hashimoto’s disease when the immune system attacks the thyroid and causes hypothyroidism and Graves’ disease which involves an overactive thyroid leading to hyperthyroidism.
TSH serum measurements are used as a first-line screening assay to help diagnose thyroid disorders and to monitor treatment of hypothyroidism and hyperthyroidism. The capability of a TSH assay to distinguish between normal and subnormal concentrations is critical and quantification capabilities of 0.01 ml U/L or lower yields information that is useful to clinicians referring patients with subnormal TSH concentrations.
TSH assays are generally competitive or two-site immunoassays They are prone to interference from several sources including (1) macro-TSH (the circulating form of TSH) (2) biotin (3) anti-streptavidin antibodies (4) anti-ruthenium (-Ru) antibodies (5) TH autoantibodies and (6) heterophilic antibodies. Heterophilic antibodies can be mitigated using animal IgG and HAMA blockers, however, due to lack of time and high cost, routine screening for interference is not feasible for testing all samples. Therefore, only samples in which interference is suspected generally require additional tests to further characterize the interference.
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