Position statement: Utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position...

Area of Science:

• Endocrinology
• Clinical Chemistry
• Laboratory Medicine

Background:

• Clinical assays for testosterone are widely used for diagnosis and monitoring.
• Current methods may lack standardization, impacting accuracy and reliability.
• The Endocrine Society convened a committee to address these issues.

Purpose of the Study:

• To evaluate the current landscape of clinical assays for total and free testosterone.
• To identify areas for improvement in testosterone measurement standardization.
• To provide recommendations for future clinical assay development and implementation.

Main Methods:

• A literature review of published data was conducted using major scientific databases.
• Expert opinion from a committee appointed by The Endocrine Society was incorporated.
• Data from professional organizations like the College of American Pathologists were utilized.

Main Results:

• Proficiency testing for testosterone assays should prioritize accuracy and precision over method agreement.
• Standardization of testosterone measurements is essential for reliable clinical interpretation.
• There is a need for established normative values for total and free testosterone across different populations.

Conclusions:

• Laboratory proficiency testing must focus on accurate measurement of known testosterone concentrations.
• Standardization of testosterone assays will enable the establishment of reliable normative values.
• Future efforts should aim to establish gender- and age-specific reference ranges for testosterone, considering influencing factors.