Lab Matters Spring 2017 - Page 7

environmental health The PATH to Improved Hormone Testing by Robert Rej, PhD, director, Clinical Chemistry and Hematology, Laboratory of Molecular Diagnostics, Wadsworth Center, New York State Department of Health PATH Steering Committee members at the Endocrine Society Offices in February 2016 A ccurate test results for hormones are critically important for patient care and increasingly used in public health studies assessing environmental or chemical exposure. Some environmental pollutants can act as “endocrine disruptors” and potentially interfere with the function of the endocrine system. APHL's Environmental Health Committee supports the activities of the Partnership for the Accurate Testing of Hormones (PATH) to improve the reliability and quality of hormone measurements nationally. Established in 2010 to provide better hormone tests for use in healthcare and research to improve patient care, PATH is comprised of 14 clinical, medical and public health organizations dedicated to the improvement and appropriate use of hormone testing. PATH provides technical and scientific support to CDC’s Hormone Standardization (HoSt) Program, conducts educational activities on hormone measurement and advocates for the use of standardized hormone assays whenever they are available. disruptors is important, human studies sometimes require measuring the hormones themselves in serum or plasma to accurately assess health effects. Using well-standardized methods to quantitate hormones is key to obtaining comparable results from other laboratories. The two ISO standards applicable to analytical and medical laboratories (ISO 17025 and 15189) require laboratories to estimate their measurement uncertainty. Unfortunately, some laboratory measurement errors and bias—particularly between-laboratory differences—can be significant and can lead to a lack of comparability for hormone measurements. The Importance of Harmonization The “Disruptor” Link Some environmental pollutants can act as “endocrine disruptors”—disturbing the synthesis, circulating concentrations and/or the action of hormones on peripheral tissues—and potentially interfere with the regular function of the endocrine system. For example, dioxins are known to promote or antagonize the effects of estrogens—steroid hormones that regulate the function of reproductive tissues and other organs. While measuring the amount of endocrine Key to the poor performance of some hormone tests is the lack of standardization of generally accepted performance standards, and of systems to assess and monitor measurement performance. Exacerbating these technical problems is a general lack of awareness among physicians and researchers of the potential for poor quality results and lack of harmonization of these tests. Inadequate test performance prevents the implementation of patient treatment guidelines and research findings into the clinical setting, preventing optimal and cost-effective patient care. PATH’s current focus is largely diagnostic, but as the program evolves, APHL aims to raise awareness of environmental causes of alterations in hormone concentrations and the importance of accurate hormone measurements in public health research and surveillance. Resources: National Institute of Environmental Health Sciences (NIEHS) page on Endocrine Disruptors: http://www.niehs.nih.gov/health/topics/agents/endocrine/ Partnership for the Accurate Testing of Hormones: http://www.hormoneassays.org/ CDC Hormone Standardization Brochure: http://www.cdc.gov/labstandards/pdf/hs/HoSt_Brochure.pdf PublicHealthLabs @APHL APHL.org PATH and its participating partners have made tremendous advances in improving testosterone analyses. Many of the testosterone tests in use today have been certified by the CDC HoSt program, and patients, clinicians and researchers are reaping the benefits of accurate, reliable and comparable results. Broad engagement by stakeholders and a comprehensive approach to technical and policy-related barriers are important to PATH’s success. As it continues its work on testosterone, PATH is expanding its focus to include standardization of other hormone tests, and, in so doing, working toward improved health for all. PATH currently comprises 14 clinical, medical and public health organizations dedicated to the improvement and appropriate use of hormone testing. It provides technical and scientific support to the CDC Steroid Hormone Standardization Program, conducts educational activities on hormone measurement, and advocates for the use of standardized hormone assays whenever they are available. • American Association for Clinical Chemistry • American Society for Bone and Mineral Research • American Thyroid Association • American Urological Association • Androgen Excess/PCOS Society • APHL • College of American Pathologists • Endocrine Society • International Society of Andrology • LabCorp • National Association of Chronic Disease Directors • North American Menopause Society • Pediatric Endocrine Society • Quest Diagnostics Spring 2017 LAB MATTERS 5