Accurate Measurement and Harmonized Reference Ranges for Total and Free Testosterone Levels

Endocrinol Metab Clin North Am. 2022 Mar;51(1):63-75. doi: 10.1016/j.ecl.2021.11.002.

Abstract

Diagnosing testosterone deficiency requires accurate and precise measurement of total testosterone levels by an accurate method, such as liquid chromatography-tandem mass spectrometry in a laboratory certified by an accuracy-based program (eg, Centers for Disease Control and Prevention's Hormone Standardization (HoST) Program), and, if needed, free testosterone level. Free testosterone level should ideally be measured by equilibrium dialysis method. Testosterone levels should be measured in 2 or more fasting samples obtained in the morning. Harmonized reference ranges for total testosterone can be applied to laboratories that certified by the HoST Program.

Keywords: Ensemble ALlstery Model; Equilibrium dialysis; Free testosterone; Harmonized reference ranges for testosterone; Hypogonadism; Testosterone assays; Testosterone deficiency; Total testosterone.

Publication types

  • Review

MeSH terms

  • Chromatography, Liquid / methods
  • Humans
  • Reference Standards
  • Reference Values
  • Tandem Mass Spectrometry* / methods
  • Testosterone*

Substances

  • Testosterone