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TSH, Ultrasensitive 8660X Clinical Use • Diagnose hypo- and hyperthyroidism • Monitor T4-replacement or T4suppressive therapy • Quantify TSH levels in the subnormal range Reference Range Adults Men and nonpregnant women Pregnant women 1st trimester 2nd trimester 3rd trimester Children 1-4 d 5-6 d 1-4 wk 1-12 mo 1-19 y mU/L 0.40-4.50 0.30-4.50 0.50-4.60 0.80-5.20 3.20-35.00 Not established* 1.70-9.10 0.80-8.20 0.50-4.30 *TSH levels decline rapidly during the first week of life in most children, but may remain transiently elevated in a few individuals despite normal free T4 levels. For confirmatory testing following a newborn thyroid screen, a free (or total) T4 level is usually required for proper interpretation of TSH levels in this age group. Interpretive Information • Primary hypothyroidism • Decreased thyroid reserve (sub-clinical hypothyroidism) • TSH-dependent hyperthyroidism • Thyroid hormone resistance Clinical Background The serum TSH measurement is 1 of the most important tools in the diagnosis of thyroid disorders. TSH secretion from the pituitary gland is controlled by hypothalamic TRH and a negative feedback effect from circulating, free thyroid hormones. Thus, in subjects with a normal hypothalamic-pituitary system, there is an inverse correlation between free thyroid hormone and TSH concentrations in serum. Increased serum TSH is an early and sensitive indicator of decreased thyroid reserve and overt primary hypothyroidism. A third-generation TSH assay using chemiluminescent technology produces functional sensitivities of 0.01 mU/L, permitting reliable quantification of serum TSH concentrations in the subnormal range. This allows differentiation of euthyroid from hyperthyroid patients. This assay also helps diagnose essentially all patients with TSH-independent hyperthyroidism (Graves disease, etc.) with a single blood sample. In addition, the assay allows adjustment of exogenous thyroxine dosage in hypothyroid patients and in patients on suppressive thyroxine therapy for thyroid neoplasia. Method • Immunochemiluminometric assay (ICMA) • Analytical sensitivity: 0.01 mU/L Specimen Requirements 2 mL refrigerated serum (no additive red top tube); 0.5 mL minimum • Graves disease • Autonomous thyroid hormone secretion • TSH deficiency 180