The laboratory diagnosis of testosterone deficiency

Darius A. Paduch, Robert E. Brannigan, Eugene Fuchs, Edward D. Kim, Joel L. Marmar, Jay I. Sandlow

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

The evaluation and treatment of hypogonadal men has become an important part of urologic practice. Fatigue, loss of libido, and erectile dysfunction are commonly reported, but nonspecific symptoms and laboratory verification of low testosterone (T) are an important part of evaluation in addition to a detailed history and physical examination. Significant intraindividual fluctuations in serum T levels, biologic variation of T action on end organs, the wide range of T levels in human serum samples, and technical limitations of currently available assays have led to poor reliability of T measurements in the clinical laboratory setting. There is no universally accepted threshold of T concentration that distinguishes eugonadal from hypogonadal men; thus, laboratory results have to be interpreted in the appropriate clinical setting. This review focuses on clinical, biological, and technological challenges that affect serum T measurements to educate clinicians regarding technological advances and limitations of the currently available laboratory methods to diagnose hypogonadism. A collaborative effort led by the American Urological Association between practicing clinicians, patient advocacy groups, government regulatory agencies, industry, and professional societies is underway to provide optimized assay platforms and evidence-based normal assay ranges to guide clinical decision making. Until such standardization is commonplace in clinical laboratories, the decision to treat should be based on the presence of signs and symptoms in addition to serum T measurements. Rigid interpretation of T ranges should not dictate clinical decision making or define coverage of treatment by third party payers.

Original languageEnglish (US)
Pages (from-to)980-988
Number of pages9
JournalUrology
Volume83
Issue number5
DOIs
StatePublished - 2014

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Clinical Laboratory Techniques
Testosterone
Serum
Health Insurance Reimbursement
Patient Advocacy
Government Agencies
Libido
Hypogonadism
Erectile Dysfunction
Signs and Symptoms
Physical Examination
Fatigue
Industry
Reference Values
History
Therapeutics
Clinical Decision-Making

ASJC Scopus subject areas

  • Urology

Cite this

Paduch, D. A., Brannigan, R. E., Fuchs, E., Kim, E. D., Marmar, J. L., & Sandlow, J. I. (2014). The laboratory diagnosis of testosterone deficiency. Urology, 83(5), 980-988. https://doi.org/10.1016/j.urology.2013.12.024

The laboratory diagnosis of testosterone deficiency. / Paduch, Darius A.; Brannigan, Robert E.; Fuchs, Eugene; Kim, Edward D.; Marmar, Joel L.; Sandlow, Jay I.

In: Urology, Vol. 83, No. 5, 2014, p. 980-988.

Research output: Contribution to journalArticle

Paduch, DA, Brannigan, RE, Fuchs, E, Kim, ED, Marmar, JL & Sandlow, JI 2014, 'The laboratory diagnosis of testosterone deficiency', Urology, vol. 83, no. 5, pp. 980-988. https://doi.org/10.1016/j.urology.2013.12.024
Paduch DA, Brannigan RE, Fuchs E, Kim ED, Marmar JL, Sandlow JI. The laboratory diagnosis of testosterone deficiency. Urology. 2014;83(5):980-988. https://doi.org/10.1016/j.urology.2013.12.024
Paduch, Darius A. ; Brannigan, Robert E. ; Fuchs, Eugene ; Kim, Edward D. ; Marmar, Joel L. ; Sandlow, Jay I. / The laboratory diagnosis of testosterone deficiency. In: Urology. 2014 ; Vol. 83, No. 5. pp. 980-988.
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