BACKGROUND: Establishment of trimester- and assay-specific reference intervals for every population is recommended. The aim of this study was to establish a trimester- and assay-specific reference interval for thyroid-stimulating hormone (TSH) and free thyroxine (FT4) in Korean pregnant women. METHODS: From April 2012 to December 2012, 531 pregnant women receiving prenatal care and 238 age-matched, non-pregnant women were enrolled in this study. After excluding patients with pregnancy-associated complications or thyroid-specific autoantibody, 465 pregnant and 206 non-pregnant women were included. Non-parametric analysis (2.5-97.5th percentile) was performed to determine the reference interval. Levels of TSH and FT4 were determined by electrochemiluminescence immunoassay (Elecsys thyroid tests, Roche Diagnostics, Germany). RESULTS: The TSH reference intervals were 0.01-4.10, 0.01-4.26, and 0.15-4.57 mIU/L for the first, second, and third trimester, respectively. From the first trimester to the third trimester, the median TSH levels showed a significantly increasing trend (P<0.0001). The FT4 reference intervals were 0.83-1.65, 0.71-1.22, and 0.65-1.13 ng/dL for the first, second, and third trimester, respectively, showing a significantly decreasing trend (P<0.0001). CONCLUSIONS: Establishing trimester-specific reference intervals in pregnant women is essential for accurate assessment of thyroid function. Our population-specific and method-specific reference intervals will be useful for screening Korean pregnant women for thyroid disease.
Adult ; Asian Continental Ancestry Group ; Case-Control Studies ; Female ; Humans ; *Immunoassay/standards ; Luminescent Measurements ; Pregnancy ; Pregnancy Trimesters ; Prenatal Care ; Reference Values ; Republic of Korea ; Thyroid Hormones/*analysis/standards ; Thyroxine/*analysis/standards