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Need More Than Lab Test to Determine Low T

Lizard King

Lizard King

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Sep 9, 2010
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Decent article:

Need More Than Lab Test to Determine Low T

Need More Than Lab Test to Determine Low T

Published: Mar 7, 2014
small_Charles_Bankhead_2013.jpg

By Charles Bankhead, Staff Writer, MedPage Today



A Limitations of current laboratory tests for testosterone deficiency have led to poor reliability that preclude use of any test as the sole basis for diagnosis, authors of a review concluded.

Performance characteristics and diagnostic parameters of the tests lack standardization. Combined with inherent fluctuations in testosterone levels, the limitations mandate a diagnostic approach that relies on clinical signs and symptoms of hypogonadism as much as it does laboratory results, according to an article published online in Urology.
"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 testosterone measurements," Darius A. Paduch, MD, of Weill Cornell Medical College in New York City, and co-authors concluded.
"Rigid interpretation of testosterone ranges should not dictate clinical decision making or define coverage of treatment by third-party payers."
The American Urological Association has initiated a collaborative effort to improve standardization and reliability of testosterone assessment, involving physicians, patient advocacy groups, government agencies, industry, and professional societies, the authors added.
The problematic state of testosterone assessment begins with a lack of consensus about the definition of "low" testosterone among endocrinologists, urologists, and clinical pathologists. Published ranges for normal are based primarily on measurements in older men and are not designed to establish ranges in men with normal sexual and reproductive function, the authors noted.
Normal ranges should be based on testosterone levels derived from a predefined health index population, they added.
Furthermore, multiple obstacles stand in the way of standardized and reliable assessment of testosterone levels, including:

  • Variation in serum levels. Influences include aging, obesity, thyroid dysfunction, diabetes, estrogens, and certain other diseases and drugs.
  • What to measure. Sex-hormone binding globulin-bound testosterone accounts for 44% of the total but is unavailable to cells and affected by multiple conditions. Albumin-bound testosterone accounts for about 50% of the total and is weakly bound. Corticosteroid binding globulin-bound testosterone accounts for about 4% and is weakly bound. Free testosterone represents only 2% to 3% of the total.
  • One size does not fit all. Serum testosterone concentrations can vary by more than three orders of magnitude, depending on age, health, and other factors. No test might accurately capture the variation.
  • Test technology. Radioimmunoassays, immunoassays, and liquid chromatography-mass spectrometry employ different principles to assess testosterone levels, and all have limitations
  • Lack of standardization. Includes definitions, parameters assessed, and reporting; there is no mandatory quality-control program
"At this point, no specific assay can be recommended as superior, but each assay should be compared with minimum standards of accuracy on the basis of biologic variation," the authors noted.
The review led to a position statement that reflects the authors' findings and concerns about the current state of laboratory assessment of serum testosterone. The statement comprises two basic principles: 1) Give equivalent weight to signs and symptoms of hypogonadism and to laboratory assessment; 2) No patient should be denied coverage of testosterone testing, given the limitations of current tests.
 
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