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Comparison of serum testosterone and estradiol measurements in 3174 European men using platform immunoassay and mass spectrometry; relevance for the diagnostics in aging men

Huhtaniemi, Ilpo T.; Tajar, Abdelouahid; Lee, David M.; O'Neill, Terence W.; Finn, Joseph D.; Bartfai, Gyoergy; Boonen, Steven; Casanueva, Felipe F.; Giwercman, Aleksander LU and Han, Thang S., et al. (2012) In European Journal of Endocrinology 166(6). p.983-991
Abstract
Background: The limitations of serum testosterone and estradiol (E-2) measurements using nonextraction platform immunoassays (IAs) are widely recognized. Switching to more specific mass spectrometry (MS)-based methods has been advocated, but directly comparative data on the two methods are scarce. Methods: We compared serum testosterone and E-2 measurements in a large sample of middle-aged/elderly men using a common platform IA and a gas chromatography (GC)-MS method, in order to assess their limitations and advantages, and to diagnose male hypogonadism. Of subjects from the European Male Aging Study (n = 3174; age 40-79 years), peripheral serum testosterone and E-2 were analyzed using established commercial platform IAs (Roche Diagnostics... (More)
Background: The limitations of serum testosterone and estradiol (E-2) measurements using nonextraction platform immunoassays (IAs) are widely recognized. Switching to more specific mass spectrometry (MS)-based methods has been advocated, but directly comparative data on the two methods are scarce. Methods: We compared serum testosterone and E-2 measurements in a large sample of middle-aged/elderly men using a common platform IA and a gas chromatography (GC)-MS method, in order to assess their limitations and advantages, and to diagnose male hypogonadism. Of subjects from the European Male Aging Study (n = 3174; age 40-79 years), peripheral serum testosterone and E-2 were analyzed using established commercial platform IAs (Roche Diagnostics E170) and in-house GC MS methods. Results: Over a broad concentration range, serum testosterone concentration measured by IA and MS showed high correlation (R=0.93, P<0.001), which was less robust in the hypogonadal range (<11 nmol/l; R=0.72, P<0.001). The IA/MS correlation was weaker in E-2 measurements (R=0.32, P<0.001, at E-2 <40.8 pmol/l, and R=0.74, P<0.001, at E-2 >40.8 pmol/l). Using MS as the comparator method, IA ascertained low testosterone compatible with hypogonadism (<11 nmol/l), with 75% sensitivity and 96.3% specificity. The same parameters with IA for the detection of low E-2 (<40.7 pmol/l) were 13.3 and 99.3%, and for high E-2 (>120 pmol/l) 88.4 and 88.6%. Conclusion: A validated platform IA is sufficient to detect subnormal testosterone concentrations in the diagnosis of male hypogonadism. The IA used for E-2 measurements showed poor correlation with MS and may only be suitable for the detection of high E-2 in men. (Less)
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European Journal of Endocrinology
volume
166
issue
6
pages
983 - 991
publisher
Society of the European Journal of Endocrinology
external identifiers
  • wos:000304541100004
  • scopus:84861331756
ISSN
1479-683X
DOI
10.1530/EJE-11-1051
language
English
LU publication?
yes
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b6d2a25a-36e6-41bc-8212-1b53f7a154c3 (old id 2890556)
date added to LUP
2012-08-01 09:39:32
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2017-10-22 03:30:50
@article{b6d2a25a-36e6-41bc-8212-1b53f7a154c3,
  abstract     = {Background: The limitations of serum testosterone and estradiol (E-2) measurements using nonextraction platform immunoassays (IAs) are widely recognized. Switching to more specific mass spectrometry (MS)-based methods has been advocated, but directly comparative data on the two methods are scarce. Methods: We compared serum testosterone and E-2 measurements in a large sample of middle-aged/elderly men using a common platform IA and a gas chromatography (GC)-MS method, in order to assess their limitations and advantages, and to diagnose male hypogonadism. Of subjects from the European Male Aging Study (n = 3174; age 40-79 years), peripheral serum testosterone and E-2 were analyzed using established commercial platform IAs (Roche Diagnostics E170) and in-house GC MS methods. Results: Over a broad concentration range, serum testosterone concentration measured by IA and MS showed high correlation (R=0.93, P&lt;0.001), which was less robust in the hypogonadal range (&lt;11 nmol/l; R=0.72, P&lt;0.001). The IA/MS correlation was weaker in E-2 measurements (R=0.32, P&lt;0.001, at E-2 &lt;40.8 pmol/l, and R=0.74, P&lt;0.001, at E-2 &gt;40.8 pmol/l). Using MS as the comparator method, IA ascertained low testosterone compatible with hypogonadism (&lt;11 nmol/l), with 75% sensitivity and 96.3% specificity. The same parameters with IA for the detection of low E-2 (&lt;40.7 pmol/l) were 13.3 and 99.3%, and for high E-2 (&gt;120 pmol/l) 88.4 and 88.6%. Conclusion: A validated platform IA is sufficient to detect subnormal testosterone concentrations in the diagnosis of male hypogonadism. The IA used for E-2 measurements showed poor correlation with MS and may only be suitable for the detection of high E-2 in men.},
  author       = {Huhtaniemi, Ilpo T. and Tajar, Abdelouahid and Lee, David M. and O'Neill, Terence W. and Finn, Joseph D. and Bartfai, Gyoergy and Boonen, Steven and Casanueva, Felipe F. and Giwercman, Aleksander and Han, Thang S. and Kula, Krzysztof and Labrie, Fernand and Lean, Michael E. J. and Pendleton, Neil and Punab, Margus and Silman, Alan J. and Vanderschueren, Dirk and Forti, Gianni and Wu, Frederick C. W.},
  issn         = {1479-683X},
  language     = {eng},
  number       = {6},
  pages        = {983--991},
  publisher    = {Society of the European Journal of Endocrinology},
  series       = {European Journal of Endocrinology},
  title        = {Comparison of serum testosterone and estradiol measurements in 3174 European men using platform immunoassay and mass spectrometry; relevance for the diagnostics in aging men},
  url          = {http://dx.doi.org/10.1530/EJE-11-1051},
  volume       = {166},
  year         = {2012},
}