Men and women of any age can be affected by hormone issues. Excesses and deficiencies in hormones are to blame for many health conditions. Hormone assays help detect these imbalances and determine if an individual’s hormone levels are optimal for good health.

In women, hormone imbalances may result in infertility, premenstrual syndrome, mood swings, anxiety, sleep disturbances, and painful periods as well as weight gain, depression, bone loss, and breast cancer.

The issues that affect men are imbalances in growth hormone and testosterone. The most common symptoms of male hormone imbalances are erectile dysfunction, low libido, mood fluctuations, muscle loss or weakness, increased body fat, hair loss, memory loss, heart palpitations, insomnia, and gynecomastia (overly large breasts in men).

Since 1970, immunoassays have become the routine method of hormone testing and the non-radioactive enzyme-linked immunosorbent assay (ELISA) is considered reliable and quite sensitive. However, one of the most important challenges of hormone assay testing is the variability of the results. The Centers for Disease Control and Prevention (CDC) point out that test variability can affect patient care and leads to several issues:

  • Different laboratories adopting different criteria for “normal” and “abnormal” test values
  • Differing clinical interpretations of test results on the same patient
  • Misdiagnoses, delayed diagnoses, or suboptimal patient care
  • Repeat testing when patients change doctors or when doctors change laboratories

Inaccurate test results affect patients and also escalate research and healthcare costs. To resolve test result variability issues, the CDC began a project to standardize hormone measurements in 2007. The aim is to ensure accurate and comparable testing results across assays, across clinical laboratories and over time. The project aims to

  • Developing and implementing reference methods
  • Establishing an assay and laboratory calibration program for assay manufacturers and labs with calibration to ensure that calibration does not change over time
  • Developing lab surveys to assess and improve the measurement of testosterone and estradiol
  • Working in sync with professional organizations and institutions to develop training and education materials for goal-specific assay selection by end users, improving the assay testing process, and enhancing related documentation procedures.

Measurement of the output of endocrine glands and the concentrations of hormone in target tissue is the foundation basis of modern endocrinology. Improving the reliability of hormone assays is the key to meaningful clinical decisions and public health actions.