The Problem and The Solution

Hormone Test Standardization is Needed and Possible

With precise, universally accepted measurements and ranges for “normal” and “abnormal” hormone levels, physicians determine the appropriate care for their patients, and researchers will have reliable information that furthers our understanding of disease.

Yet today, standardized measurements exist only for two of the human body’s many hormones—and not all healthcare providers are working with (or even aware of) labs that provide these tests.

What happens when test variability isn’t controlled by standardization?

  • Misdiagnoses lead to suboptimal care.
  • Tests need to be repeated when patients change doctors or doctors change laboratories, incurring unnecessary costs and delaying diagnoses.
  • Researchers aren’t able to compare test results across studies, pool data or build new research on existing data.

All of this hinders our ability as a nation to practice evidence-based medicine, understand the hormone-related conditions that affect millions and use hormone research to improve clinical practice and public health.

The PATH to a healthier tomorrow

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Awareness: Knowledge is power. When policymakers, the medical community and the public grasp the prevalence of hormone testing and the importance of standardized measurements, change will happen.

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Incentives: Despite the costs of misdiagnoses, delays in care and unnecessary retests, most health plans and insurance providers currently do not educate physicians about standardized testing or encourage them to work with labs that offer it. More reliable hormone measurements depend on sound policy, and a system that rewards smart choices.

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Resources: CDC has successfully standardized tests for testosterone and estradiol through work in the four areas outlined below. But dozens more hormones lack standardized measurements.

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Reference methods: Using "pure compound" hormones, researchers assign precise values to the hormone concentration in blood samples for test calibration. This provides a highly accurate standard for comparing test results.

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Assay and laboratory calibration: CDC’s Reference Laboratory works with testing laboratories to test serum samples—and considers a laboratory "standardized" when its results meet predefined criteria.

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Laboratory surveys: Surveys allow laboratories to be sure their test results continue to meet performance standards.

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Training and education materials: These provide researchers and doctors with appropriate reference ranges for specific hormones, guidance on selecting the specific method used to measure a hormone and ways to improve the testing process.