Anckaert Ellen, Jank Alexander, Petzold Julia, Rohsmann Felix, Paris Rhonda, Renggli Martin, Schönfeld Kathrin, Schiettecatte Johan, Kriner Monika
Laboratory of Hormonology and Tumour Markers, University Hospital Brussels (UZ Brussel), Free University of Brussels, Laarbeeklaan 101, B-1090, Brussels, Belgium.
University Hospital Leipzig, Liebigstraße 20, 04103, Leipzig, Germany.
Pract Lab Med. 2021 Mar 13;25:e00211. doi: 10.1016/j.plabm.2021.e00211. eCollection 2021 May.
Expected values for estradiol (E2), luteinizing hormone (LH), and progesterone determined in serum allow accurate assessment of menstrual cycle phase. Automated immunoassays demonstrate variable degrees of bias, emphasizing the need to establish method-specific reference values. We therefore established method-specific reference intervals for the Elecsys® LH assay and new generation Elecsys Estradiol III and Progesterone III assays (cobas e 801 analyzer) in 85 apparently healthy women aged 22-37 (US)/18-37 (EU) years over one natural menstrual cycle. Cycle length and day of ovulation were standardized; phases were defined by LH surge and/or progesterone/E2 levels. Median (5th-95th percentile) concentrations (follicular/ovulation/luteal) were E2: 198 pmol/L (114-332), 757 pmol/L (222-1959) and 412 pmol/L (222-854); LH: 7.14 IU/L (4.78-13.2), 22.6 IU/L (8.11-72.7) and 6.24 IU/L (2.73-13.1); progesterone: 0.212 nmol/L (0.159-0.616), 1.81 nmol/L (0.175-13.2) and 28.8 nmol/L (13.1-46.3). Sub-phase (early/intermediate/late) reference values were also determined for follicular and luteal phases. This multicenter study established reliable, method-specific E2, LH and progesterone reference values that could assist clinical decision-making in women with fertility disorders and monitoring of natural cycles in assisted reproductive treatment.
血清中雌二醇（E2）、促黄体生成素（LH）和孕酮的预期值可用于准确评估月经周期阶段。自动化免疫分析显示出不同程度的偏差，这凸显了建立特定方法参考值的必要性。因此，我们在85名年龄在22 - 37岁（美国）/18 - 37岁（欧盟）的明显健康女性中，针对Elecsys® LH检测以及新一代Elecsys雌二醇III和孕酮III检测（cobas e 801分析仪），在一个自然月经周期内建立了特定方法的参考区间。月经周期长度和排卵日被标准化；各阶段通过LH峰和/或孕酮/E2水平来定义。中位数（第5 - 95百分位数）浓度（卵泡期/排卵期/黄体期）分别为：E2：198皮摩尔/升（114 - 332）、757皮摩尔/升（222 - 1959）和412皮摩尔/升（222 - 854）；LH：7.14国际单位/升（4.78 - 13.2）、22.6国际单位/升（8.11 - 72.7）和6.24国际单位/升（2.73 - 13.1）；孕酮：0.212纳摩尔/升（0.159 - 0.616）、1.81纳摩尔/升（0.175 - 13.2）和28.8纳摩尔/升（13.1 - 46.3）。还确定了卵泡期和黄体期亚阶段（早期/中期/晚期）的参考值。这项多中心研究建立了可靠的、特定方法的E2、LH和孕酮参考值，可协助对患有生育障碍的女性进行临床决策以及在辅助生殖治疗中监测自然周期。
