Amsterdam UMC, Vrije Universiteit Amsterdam, Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam Gastroenterology & Metabolism, Amsterdam, Netherlands.
Centers of Disease Control and Prevention, 4770 Buford Highway, NE F25, Atlanta 30341-3724, Georgia.
Clin Chim Acta. 2019 Aug;495:198-204. doi: 10.1016/j.cca.2019.04.062. Epub 2019 Apr 11.
For optimal medical decision-making, harmonized reference intervals for estradiol for different ages and both sexes are needed. Our aim was to establish reference intervals using a highly accurate and traceable LC-MS/MS method and to compare these with reference intervals in literature.
Estradiol was measured in serum obtained daily during the menstrual cycle of 30 healthy premenopausal women and in serum of 64 men and 33 postmenopausal women. The accuracy of our LC-MS/MS method was demonstrated by a method comparison with the CDC reference method.
Our LC-MS/MS method was traceable to the reference method. Estradiol reference interval during the early follicular phase (days -15 to -6) was 31-771 pmol/L; during the late follicular phase (days -5 to -1) 104-1742 pmol/L; during the LH peak (day 0) 275-2864 pmol/L; during the early luteal phase (days +1 to +4) 95-1188 pmol/L; during mid luteal phase (days +5 to +9) 151-1941 pmol/L; during late luteal phase (days +10 to +14) 39-1769 pmol/L. The reference interval for men was 12-136 pmol/L and for postmenopausal women <26 pmol/L.
The established estradiol reference intervals can be used for all traceable LC-MS/MS methods for medical-decision making.
为了做出最佳的医学决策，需要针对不同年龄和性别制定协调一致的雌二醇参考区间。我们的目的是使用高度准确且可溯源的 LC-MS/MS 方法建立参考区间，并与文献中的参考区间进行比较。
我们在 30 名健康绝经前女性的月经周期期间每天采集血清，并在 64 名男性和 33 名绝经后女性的血清中测量雌二醇。我们的 LC-MS/MS 方法的准确性通过与 CDC 参考方法的方法比较得到证明。
我们的 LC-MS/MS 方法可溯源至参考方法。卵泡早期（-15 至-6 天）的雌二醇参考区间为 31-771 pmol/L；卵泡晚期（-5 至-1 天）为 104-1742 pmol/L；LH 峰（第 0 天）时为 275-2864 pmol/L；黄体早期（+1 至+4 天）为 95-1188 pmol/L；黄体中期（+5 至+9 天）为 151-1941 pmol/L；黄体晚期（+10 至+14 天）为 39-1769 pmol/L。男性的参考区间为 12-136 pmol/L，绝经后女性<26 pmol/L。
所建立的雌二醇参考区间可用于所有可溯源的 LC-MS/MS 方法进行医学决策。
