Comparison of serum testosterone and estradiol measurements in 3174 European men using platform immunoassay and mass spectrometry; relevance for the diagnostics in aging men
BackgroundThe limitations of serum testosterone and estradiol (E2) measurements using non-extraction 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.Meth...
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Published in | European journal of endocrinology Vol. 166; no. 6; pp. 983 - 991 |
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Main Authors | , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Bristol
BioScientifica
01.06.2012
|
Subjects | |
Online Access | Get full text |
ISSN | 0804-4643 1479-683X 1479-683X |
DOI | 10.1530/EJE-11-1051 |
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Abstract | BackgroundThe limitations of serum testosterone and estradiol (E2) measurements using non-extraction 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.MethodsWe compared serum testosterone and E2 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 E2 were analyzed using established commercial platform IAs (Roche Diagnostics E170) and in-house GC–MS methods.ResultsOver 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 E2 measurements (R=0.32, P<0.001, at E2 <40.8 pmol/l, and R=0.74, P<0.001, at E2 >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 E2 (<40.7 pmol/l) were 13.3 and 99.3%, and for high E2 (>120 pmol/l) 88.4 and 88.6%.ConclusionA validated platform IA is sufficient to detect subnormal testosterone concentrations in the diagnosis of male hypogonadism. The IA used for E2 measurements showed poor correlation with MS and may only be suitable for the detection of high E2 in men. |
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AbstractList | 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 correlationwas 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. BackgroundThe limitations of serum testosterone and estradiol (E2) measurements using non-extraction 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.MethodsWe compared serum testosterone and E2 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 E2 were analyzed using established commercial platform IAs (Roche Diagnostics E170) and in-house GC–MS methods.ResultsOver 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 E2 measurements (R=0.32, P<0.001, at E2 <40.8 pmol/l, and R=0.74, P<0.001, at E2 >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 E2 (<40.7 pmol/l) were 13.3 and 99.3%, and for high E2 (>120 pmol/l) 88.4 and 88.6%.ConclusionA validated platform IA is sufficient to detect subnormal testosterone concentrations in the diagnosis of male hypogonadism. The IA used for E2 measurements showed poor correlation with MS and may only be suitable for the detection of high E2 in men. The limitations of serum testosterone and estradiol (E(2)) measurements using non-extraction 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.BACKGROUNDThe limitations of serum testosterone and estradiol (E(2)) measurements using non-extraction 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.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.METHODSWe 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.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%.RESULTSOver 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%.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.CONCLUSIONA 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. The limitations of serum testosterone and estradiol (E(2)) measurements using non-extraction 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. 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. 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%. 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 | Kula, Krzysztof Silman, Alan J Wu, Frederick C W Casanueva, Felipe F Huhtaniemi, Ilpo T O'Neill, Terence W Lean, Michael E J Labrie, Fernand Han, Thang S Bartfai, György Giwercman, Aleksander Vanderschueren, Dirk Lee, David M Pendleton, Neil Tajar, Abdelouahid Boonen, Steven Finn, Joseph D Punab, Margus Forti, Gianni |
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BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25986807$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22423144$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
Contributor | Kula, K Lage, Mary Corona, Giovanni Casanueva, F F Vanderschueren, D Jiang, Min Slowikowska-Hilczer, Jolanta Pye, Stephen O'Neill, T W Lee, D M Fejes, Imre Tajar, A Steer, Philip Finn, J D Boonen, S Punab, M Silman, A J Castro, Ana I Petrone, Luisa Borghs, Herman Wu, F C W Bartfai, G Huhtaniemi, I T Forti, G Walczak-Jedrzejowska, Renata Giwercman, A Földesi, Imre Korrovitz, Paul |
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Copyright | 2012 European Society of Endocrinology 2015 INIST-CNRS |
Copyright_xml | – notice: 2012 European Society of Endocrinology – notice: 2015 INIST-CNRS |
CorporateAuthor | EMAS Group Reproductive medicine, Malmö Faculty of Medicine Institutionen för translationell medicin Reproduktionsmedicin, Malmö Department of Translational Medicine Lunds universitet Medicinska fakulteten Lund University |
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DocumentTitleAlternate | Testosterone and estradiol assays |
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Keywords | Human Senescence Androgen Ageing Estrogen Exploration Male European Estradiol Ovarian hormone Immunological method Relevance Testosterone Serum Testicular hormone Diagnosis Sex steroid hormone Mass spectrometry Endocrinology Comparative study Public health |
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Snippet | BackgroundThe limitations of serum testosterone and estradiol (E2) measurements using non-extraction platform immunoassays (IAs) are widely recognized.... The limitations of serum testosterone and estradiol (E(2)) measurements using non-extraction platform immunoassays (IAs) are widely recognized. Switching to... Background: The limitations of serum testosterone and estradiol (E-2) measurements using nonextraction platform immunoassays (IAs) are widely recognized.... |
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SubjectTerms | Adult Aged Aging - blood Biological and medical sciences Clinical Medicine Clinical Study Cohort Studies Electrochemistry Endocrinology and Diabetes Endocrinopathies Endokrinologi och diabetes Estradiol - blood Europe Fundamental and applied biological sciences. Psychology Gas Chromatography-Mass Spectrometry Humans Hypogonadism - blood Hypogonadism - diagnosis Immunoassay - methods Klinisk medicin Luminescent Measurements Male Medical and Health Sciences Medical sciences Medicin och hälsovetenskap Middle Aged Miscellaneous Public health. Hygiene Public health. Hygiene-occupational medicine Sensitivity and Specificity Serum Albumin - metabolism Sex Hormone-Binding Globulin - metabolism Testosterone - blood Vertebrates: 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 |
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