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Cited by 35Clinical Laboratory Practices and Quality ControlOvarian function and disordersHormonal and reproductive studies

Utilization of commercial laboratory results in management of hyperandrogenism in women

Steinberger, Emil, Ayala, Carma, Hsi, Bartholomew, Smith, Keith D., Rodriguez-Rigau, Luis J., Weidman, E. Russell, Reimondo, Gerold G.·1998·Endocrine Practice
DOI 10.4158/ep.4.1.1
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Abstract

Objective To compare results from testosterone radioimmunoassay kits commonly used by commercial laboratories as well as their reference ranges and to analyze the scientific literature for ranges of serum testosterone levels in normal women and those with hyperandrogenism.Methods We reviewed quality assurance reports of various testosterone ligand challenges from four groups of laboratories and summarized testosterone data from 17 published reports about normal women and 14 studies of hyperandrogenic women.Results A significant variability was demonstrated between the radioimmunoassay kits at all concentrations (for example, a sample with a mean testosterone level of 96.1 ng/dL was reported by some laboratories as containing 71.8 ng/dL and by others as 123.4 ng/dL). All laboratories provide essentially the same "reference range" (approximately 10 to 90 ng/dL) but do not report how the range was established. The scientific literature clearly shows a significant separation in serum testosterone levels between normal (that is, not hyperandrogenic) and hyperandrogenic women. Most hyperandrogenic women had testosterone levels >50 ng/dL, whereas most normal control subjects had levels <40 ng/dL. Thus, most of these women with hyperandrogenism would have been considered to have normal testosterone levels if the reference ranges of commercial laboratories were used.Conclusion These data illustrate the difficulty that physicians face when they are required to use different commercial laboratories to measure serum testosterone levels. We propose that (1) reference ranges be established on a clinically defined population for each hormone and method used, (2) laboratory reports include information about method and reference range population, and (3) physicians be allowed to choose which laboratories are used for their patients' hormone determinations, for consistency of results.

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Authors
Steinberger, E., Ayala, C., Hsi, B., Smith, K. D., Rodriguez-Rigau, L. J., Weidman, E. R., & Reimondo, G. G.
Affiliations
The University of Texas Health Science Center at Houston (US)
Corresponding author
Steinberger, Emil
ORCID
Ayala, Carma
Venue
Endocrine Practice
Publisher
Elsevier BV
Published
1998-01
Volume
4
Issue
1
Pages
1-10
ISSN
1530-891X (ISSN-L)
DOI
10.4158/ep.4.1.1
OpenAlex
W2076369526
Cited by
35
References
36
Citations by year
2023: 1 · 2022: 1 · 2020: 1 · 2019: 3 · 2017: 2 · 2016: 3 · 2015: 5 · 2014: 1 · 2013: 2 · 2012: 1
FWCI
1.27
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Endocrine Practice (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Keywords
hyperandrogenism, serum testosterone, assay variability, laboratory quality assurance, women

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