Department of Obstetrics and Gynecology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Chin Med J (Engl). 2013 Jul;126(14):2710-4.
The importance of diagnosis of thyroid dysfunction during pregnancy has been widely recognized. Our study was designed to compare two different detection reagents between Abbott and Roche and to establish the gestational related reference intervals for thyroid function tests (TFT) in Chinese women and to assay the reference ranges with the American Thyroid Association recommended standard.
Serum samples were collected from 693 normal pregnant Chinese women and divided into five groups according to their gestational age: 9-13, 16-20, 24-28, 32-34 and 37-40 weeks. Thyroid stimulating hormone (TSH) and free thyroxine (FT4) levels were determined by two different detection reagents: Abbott Architect I 2000 and Roche Cobas Elecsys 600. The reference ranges of the TFT indexes were calculated according to the National Academy of Clinical Biochemistry (NACB). The 2.5th and 97.5th percentiles of each stage were calculated, and the results were analyzed by one-way analysis of variances, t-test, and Spearman correlation analysis.
Thyroid hormone levels varied greatly among different gestational stages. TSH levels, as assessed via two different TSH ELISA kits showed consistent changing pattern during pregnancy and displayed linear correlation (P < 0.001). In 9-13 gestational weeks, TSH levels were significantly lower than that of other groups; and in 37-40 gestational weeks, it was higher than that of other groups (all P < 0.001). TSH reference ranges determined by Roche detection reagent in each group were higher than those by Abbott detection reagent (P < 0.01 respectively). FT4 levels were higher in 9-13 gestational weeks than that of other groups (P < 0.001). FT4 levels determined by Roche reagent were higher than Abbott reagent in 9-13 weeks, (P < 0.001), and lower in 24-28 and 37-40 weeks (P < 0.001 and P = 0.016, respectively). The TSH level was correlated with FT4 levels in 9-13 gestational weeks by detection reagents (for Abbott reagent, r=-0.319 for FT4 P < 0.001; for Roche reagent, r=-0.352 for FT4, P <0.001).
Accurate evaluation of TFT in pregnant women should be based on the gestational-related reference intervals in Chinese population, and different detection reagents should also establish their own reference intervals.
甲状腺功能障碍的诊断在怀孕期间非常重要，这一点已经得到广泛认可。我们的研究旨在比较 Abbott 和 Roche 两种不同的检测试剂，并建立中国女性甲状腺功能检测（TFT）的妊娠相关参考区间，并与美国甲状腺协会推荐的标准进行检测。
收集 693 名正常妊娠的中国女性的血清样本，并根据其妊娠周数分为五组：9-13 周、16-20 周、24-28 周、32-34 周和 37-40 周。采用两种不同的检测试剂 Abbott Architect I 2000 和 Roche Cobas Elecsys 600 测定甲状腺刺激激素（TSH）和游离甲状腺素（FT4）水平。根据全国临床生化学会（NACB）计算 TFT 指标的参考范围。计算每个阶段的第 2.5 百分位数和第 97.5 百分位数，并通过单向方差分析、t 检验和 Spearman 相关分析进行分析。
不同妊娠阶段甲状腺激素水平差异较大。两种不同的 TSH ELISA 试剂盒检测的 TSH 水平在怀孕期间呈一致的变化趋势，且呈线性相关（P < 0.001）。在 9-13 周妊娠时，TSH 水平明显低于其他组；而在 37-40 周妊娠时，TSH 水平高于其他组（均 P < 0.001）。Roche 检测试剂在每个组中的 TSH 参考范围均高于 Abbott 检测试剂（P < 0.01）。在 9-13 周妊娠时，FT4 水平高于其他组（P < 0.001）。在 9-13 周妊娠时，Roche 试剂测定的 FT4 水平高于 Abbott 试剂（P < 0.001），而在 24-28 周和 37-40 周妊娠时则较低（P < 0.001 和 P = 0.016）。用两种检测试剂检测，9-13 周妊娠时 TSH 水平与 FT4 水平呈负相关（Abbott 试剂，r =-0.319，FT4，P < 0.001；Roche 试剂，r =-0.352，FT4，P < 0.001）。
准确评估孕妇的 TFT 应基于中国人群的妊娠相关参考区间，不同的检测试剂也应建立自己的参考区间。
