title: Improved sensitivity of serum thyrotropin measurements. Studies on serum sex hormone-binding globulin in patients with reduced serum thyrotropin.
abstract: Most serum TSH assays have a working sensitivity (i.e. the lowest TSH value with an inter-assay coefficient of variation below 10%) around 0.15-0.4 mU/l, which also is the critical area for cut off for further thyroid profile testing when serum TSH is used as a "first line test". A new assay (BeriLux hTSH) based on chemiluminescence was evaluated, and demonstrated a theoretical sensitivity (mean + 2 SD of the zero standard) of 0.005 mU/l and a working sensitivity as low as 0.04 mU/l. Reference range was 0.18-2.60 mU/l (N = 33). Sixty-eight percent (13/19) of hyperthyroid patients had serum TSH less than 0.005 mU/l, all had serum TSH less than 0.037 mU/l. We studied two groups of patients with normal free T4 and T3 indices but serum TSH less than 0.15 mU/l as measured by an immunoradiometric assay. Thirty-five percent (7/20) of patients with nontoxic goitre and 5% (1/20) of L-T4 treated patients had serum TSH less than 0.005 mU/l; and in 60% (11/20) and 30% (6/20), respectively, the levels overlapped the total range for hyperthyroidism. Serum levels of sex hormone-binding globulin expressed as percent of the reference median for the relevant sex (SHBG%) were elevated in both groups of patients (p less than 0.01). Approximately 50% of those with serum TSH overlapping the hyperthyroid range had serum SHBG% levels above reference range. In conclusion, this assay seems superior to most previously reported assays concerning working sensitivity, but it still leaves us with a group of clinically euthyroid patients who has unmeasurably low serum TSH.(ABSTRACT TRUNCATED AT 250 WORDS)
authors: Department of Endocrinology E, Frederiksberg Hospital, Denmark.
authors: J
authors: J
authors: Faber
authors: A
authors: A
authors: Gam
authors: K
authors: K
authors: Siersbaek-Nielsen
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal; D005260:Female; D006042:Goiter / Q000378:metabolism; D006801:Humans; D006980:Hyperthyroidism / Q000378:metabolism; D007037:Hypothyroidism / Q000378:metabolism; D015592:Immunoradiometric Assay; D008163:Luminescent Measurements; D008297:Male; D008875:Middle Aged; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism*; D013961:Thyroid Gland / Q000378:metabolism; D013972:Thyrotropin / Q000097:blood*; D013974:Thyroxine / Q000493:pharmacokinetics / Q000494:pharmacology; D014284:Triiodothyronine / Q000097:blood
chemical_list: D000911:Antibodies, Monoclonal; D012738:Sex Hormone-Binding Globulin; D014284:Triiodothyronine; D013972:Thyrotropin; D013974:Thyroxine