Hormone Standardization Program for Testosterone and Estradiol

Estradiol and testosterone are sex hormones responsible for human development. Both hormones influence several physiological processes, such as growth, bone and lipid metabolism, and cardiovascular function. The need for improving the accuracy of testosterone and estradiol tests through standardization has been described by organizations such as the Endocrine Society.

To measure total testosterone and estradiol in serum, CDC uses highly precise and accurate laboratory methods that employ High Performance Liquid Chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS). These methods characterize reference materials used in the HoSt program. The reference materials are used to evaluate the analytical quality of routine methods used in research, public health, and patient care.

The HoSt program assists in these areas:

• Assessment of accuracy and precision
  HoSt provides individual donor sera with reference values, which participants use to assess and improve their measurement accuracy and quality of the method. This assessment is referred to as “HoSt Phase 1.”
• Certification of analytical performance
  HoSt provides individual donor sera without reference values. Participants measure steroid hormones in these sera and report results to CDC, which compares results to actual reference values and evaluates measurement bias and imprecision. Participants meeting criteria for analytical bias and imprecision receive a certificate. This assessment is referred to as “HoSt Phase 2.”
• Monitoring accuracy
  HoSt provides serum samples that can be used to monitor the accuracy of laboratories over time. Serum samples can be provided to researchers conducting studies to monitor the accuracy of laboratory measurements for the duration of the study. Serum samples can also be provided to laboratories to monitor the accuracy of the measurements performed in the laboratory over time. This program is called the “Accuracy-based Monitoring Program” (AMP).