Steroid Hormones Standardization Programs

At a glance

CDC Hormone Standardization Programs assesses the analytical accuracy and reliability of testosterone and estradiol tests performed in clinical, research and public health laboratories.

Decorative: Samples in laboratory

Standardization of steroid hormones

Estradiol and testosterone are steroid hormones responsible for human development. Both hormones influence several physiological processes, such as growth, bone and lipid metabolism, and cardiovascular function. Accurate and reliable laboratory tests for these hormones are needed to correctly assess patients for diseases such as polycystic ovary syndrome and androgen deficiency, and to monitor the treatment of patients. The need for improving the accuracy of testosterone and estradiol tests through standardization has been described by organizations such as the Endocrine Society.

CDC improves the detection, diagnosis, and treatment of chronic diseases such as cancers and bone diseases by ensuring that laboratory tests for steroid hormones are accurate and reliable.

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 Hormone standardization program. The reference materials are used to evaluate the analytical quality of routine methods used in research, public health, and patient care.

CDC’s hormone standardization programs work to:

  • Provide metrological reference measurements procedures. These procedures are internationally recognized and are used to assist with calibration (also called establishing metrological traceability). [Hormone Reference Laboratories]
  • Assess and certify the analytical performance of testosterone and estradiol tests used in patient care, research, and public health. This includes two independent phases, known respectively as, "HoSt Phase 1" and "HoSt Phase 2" (this process is also called verification of metrological traceability) [Improving Performance]
  • Monitor the accuracy of measurements performed in routine laboratories over time. In this program samples are analyzed along with regular patient or study samples. [Accuracy-based Monitoring Program (AMP)]. In addition, customized blinded quality control samples to monitor the accuracy of measurements conducted as part of research studies can be provided.

The more you know...‎

Standardization performed by CDC is an activity in which the analytical accuracy, precision, and other analytical performance parameters of a laboratory test are assessed against established, clinically relevant analytical performance goals. The accuracy, whenever possible, is assessed by comparing a test measurement against results obtained with a metrological reference method. Thus, a standardized laboratory test is a test that has demonstrated, through an assessment by CDC, an analytical performance (such as accuracy and precision), which consistently met specific analytical performance goals.

Contact the HoSt/VDSCP program

E-mail: standardization@cdc.gov

Phone: CDC Health Line - 1-800-CDC-INFO (1-800-232-4636)

Please note that CDC cannot respond to questions about individual medical cases, provide second opinions, or make specific recommendations regarding therapy. Those issues should be addressed directly with your health care provider.

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Content Source:
National Center for Environmental Health; Division of Laboratory Sciences