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
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