Experts Call for Improved Estrogen Testing Accuracy

 Commentary by   Hubert Vesper, PhD

Unreliable estrogen measurements negatively impact the treatment of and research into many hormone-related cancers and chronic conditions. To improve patient care, a panel of medical experts has called for accurate, standardized estrogen testing methods in a statement published in the June issue of the Journal of Clinical Endocrinology & Metabolism (JCEM).

The panel recommendations were developed based on discussions at an estrogen measurement workshop hosted by the Endocrine Society, American Association for Clinical Chemistry, and the Partnership for Accurate Testing of Hormones (PATH).

“Accurate data on patients’ estrogen levels are needed to ensure appropriate and effective patient care, reduce the need for retesting, and enable clinicians to implement the latest research in patient care,” said statement authors and co-chair of the PATH Steering Committee, Hubert Vesper, PhD. “Research studies, however, found high inaccuracies among different estrogen tests, especially when the test is measuring low estrogen levels in postmenopausal women, men and children.”

Recommendations Call for Standardization of Estrogen Measurement The expert panel called for improving the accuracy of measurements through standardization, and recommended supporting standardization programs like the Centers for Disease Control and Prevention’s Hormone Standardization (HoSt) Program and other efforts to ensure that estrogen measurement is accurate and consistent.

The panel advised clinicians and researchers to consider the purpose of the test when selecting an estrogen measurement method. The panel agreed that mass spectrometry and immunoassays are both valid assays for estrogens and their metabolites, but that one may be more effective than the other depending on the patient. For instance, mass spectrometry—the more expensive, but also more sensitive testing method—may be appropriate in people who tend to have low estrogen levels, including men, postmenopausal women, patients taking aromatase inhibitors, and children beginning puberty.

The panel recommended that a study be conducted to evaluate the different approaches for validating assay accuracy in order to assess the general applicability of these approaches as well as to gain insight into the strengths and limitations of each approach. In addition, the panel highlighted the need to establish age- and puberty stage-specific reference ranges for estradiol in postmenopausal women and in prepubertal/postpubertal boys and girls using validated, standardized assays.

Additionally, the experts recommended that medical journals require authors to report assay precision, accuracy, and sensitivity over the time period that the samples were tested. Furthermore, the panel recommended that the Standards of Reporting Diagnostic Accuracy (STARD) criteria used in publications dealing with the diagnostic accuracy of clinical laboratory tests should be updated to require data on a clinical assay’s analytical accuracy or bias compared to an accepted reference method.

July 14, 2015

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