An analytical method for assessing serum estradiol could allow for the development of generally recognized normal ranges of estradiol in postmenopausal women, men, and children, according to recent results presented at the American Academy of Cancer Research (AACR) 2019 Annual Meeting in Atlanta, Georgia.

Although postmenopausal women with elevated levels of estradiol are at increased risk of developing certain cancers, including breast cancer, treatment with exogenous estradiol is often used to address the symptoms of menopause. In addition, highly variable data on serum levels of estradiol, particularly in postmenopausal women, impedes establishing normal ranges and consistent treatment approaches for postmenopausal women.

Part of the variability in the data is due to a dearth of appropriate analytical methods, so researchers developed a new analytical method for measuring serum estradiol in postmenopausal and premenopausal women, men, and children. They standardized this method to the Centers for Disease Control and Prevention (CDC) Hormone Standardization Program (HoSt), a program that supports calibration of lab-developed tests by assessing assay bias and imprecision across 1 year.

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In this analytical method, adjustments for pH and polarity prior to liquid chromatography (LC)-mass spectrometry (MS) or LC analysis optimize 2 liquid-liquid extractions of serum estradiol. Automation with 96-well plates is used for sample management and extraction.

The average biases for this method ranged between –1.3% and –1.7% and were not significant. In addition, no significant differences between this method and established metrological reference methods were observed.

The sensitivity of this approach was suitable for evaluating serum estradiol in postmenopausal women, men, and children. Data from this method can be compared to other data produced by different methods standardized to CDC HoSt. Researchers are using this analytical method to measure serum estradiol in postmenopausal women in the CDC’s National Health and Nutrition Examination Survey 2013-2014.

Reference

1. Duke L, Kim PH, Cook Botelho J, Zhou H, Ulmer CZ, Vesper HW. Highly sensitive and accurate method for measuring serum estradiol in postmenopausal women and other population subgroups. Poster presented at: American Association for Cancer Research 2019 Annual Meeting; March 29-April 3, 2019; Atlanta, GA. Abstract 587/1.