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Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe

Thomas G Travison, Hubert W Vesper, Eric Orwoll, Frederick Wu, Jean Kaufman UGent, Ying Wang, Bruno Lapauw UGent, TOM FIERS, Alvin M Matsumoto and Shalender Bhasin (2017) JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM. 102(4). p.1161-1173
abstract
Background: Reference ranges for testosterone are essential for making a diagnosis of hypogonadism in men. Objective: To establish harmonized reference ranges for total testosterone in men that can be applied across laboratories by cross-calibrating assays to a reference method and standard. Population: The 9054 community-dwelling men in cohort studies in the United States and Europe: Framingham Heart Study; European Male Aging Study; Osteoporotic Fractures in Men Study; and Male Sibling Study of Osteoporosis. Methods: Testosterone concentrations in 100 participants in each of the four cohorts were measured using a reference method at Centers for Disease Control and Prevention (CDC). Generalized additive models and Bland-Altman analyses supported the use of normalizing equations for transformation between cohort-specific and CDC values. Normalizing equations, generated using Passing-Bablok regression, were used to generate harmonized values, which were used to derive standardized, age-specific reference ranges. Results: Harmonization procedure reduced intercohort variation between testosterone measurements in men of similar ages. In healthy nonobese men, 19 to 39 years, harmonized 2.5th, 5th, 50th, 95th, and 97.5th percentile values were 264, 303, 531, 852, and 916 ng/dL, respectively. Age-specific harmonized testosterone concentrations in nonobese men were similar across cohorts and greater than in all men. Conclusion: Harmonized normal range in a healthy nonobese population of European and American men, 19 to 39 years, is 264 to 916 ng/dL. A substantial proportion of intercohort variation in testosterone levels is due to assay differences. These data demonstrate the feasibility of generating harmonized reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
TANDEM MASS-SPECTROMETRY, OLDER MEN, SERUM TESTOSTERONE, STANDARDIZATION PROGRAM, OSTEOPOROTIC FRACTURES, REFERENCE INTERVALS, NATIONAL-HEART, RISK-FACTORS, LIFE-STYLE, YOUNG MEN
journal title
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
J. Clin. Endocrinol. Metab.
volume
102
issue
4
pages
1161 - 1173
Web of Science type
Article
Web of Science id
000402195300008
ISSN
0021-972X
1945-7197
DOI
10.1210/jc.2016-2935
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
8525279
handle
http://hdl.handle.net/1854/LU-8525279
date created
2017-06-27 08:37:07
date last changed
2017-07-13 11:44:56
@article{8525279,
  abstract     = {Background: Reference ranges for testosterone are essential for making a diagnosis of hypogonadism in men. 
Objective: To establish harmonized reference ranges for total testosterone in men that can be applied across laboratories by cross-calibrating assays to a reference method and standard. 
Population: The 9054 community-dwelling men in cohort studies in the United States and Europe: Framingham Heart Study; European Male Aging Study; Osteoporotic Fractures in Men Study; and Male Sibling Study of Osteoporosis. 
Methods: Testosterone concentrations in 100 participants in each of the four cohorts were measured using a reference method at Centers for Disease Control and Prevention (CDC). Generalized additive models and Bland-Altman analyses supported the use of normalizing equations for transformation between cohort-specific and CDC values. Normalizing equations, generated using Passing-Bablok regression, were used to generate harmonized values, which were used to derive standardized, age-specific reference ranges. 
Results: Harmonization procedure reduced intercohort variation between testosterone measurements in men of similar ages. In healthy nonobese men, 19 to 39 years, harmonized 2.5th, 5th, 50th, 95th, and 97.5th percentile values were 264, 303, 531, 852, and 916 ng/dL, respectively. Age-specific harmonized testosterone concentrations in nonobese men were similar across cohorts and greater than in all men. 
Conclusion: Harmonized normal range in a healthy nonobese population of European and American men, 19 to 39 years, is 264 to 916 ng/dL. A substantial proportion of intercohort variation in testosterone levels is due to assay differences. These data demonstrate the feasibility of generating harmonized reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator.},
  author       = {Travison, Thomas G and Vesper, Hubert W and Orwoll, Eric and Wu, Frederick and Kaufman, Jean and Wang, Ying and Lapauw, Bruno and FIERS, TOM and Matsumoto, Alvin M and Bhasin, Shalender},
  issn         = {0021-972X},
  journal      = {JOURNAL OF CLINICAL ENDOCRINOLOGY \& METABOLISM},
  keyword      = {TANDEM MASS-SPECTROMETRY,OLDER MEN,SERUM TESTOSTERONE,STANDARDIZATION PROGRAM,OSTEOPOROTIC FRACTURES,REFERENCE INTERVALS,NATIONAL-HEART,RISK-FACTORS,LIFE-STYLE,YOUNG MEN},
  language     = {eng},
  number       = {4},
  pages        = {1161--1173},
  title        = {Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe},
  url          = {http://dx.doi.org/10.1210/jc.2016-2935},
  volume       = {102},
  year         = {2017},
}

Chicago
Travison, Thomas G, Hubert W Vesper, Eric Orwoll, Frederick Wu, Jean Kaufman, Ying Wang, Bruno Lapauw, TOM FIERS, Alvin M Matsumoto, and Shalender Bhasin. 2017. “Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe.” Journal of Clinical Endocrinology & Metabolism 102 (4): 1161–1173.
APA
Travison, T. G., Vesper, H. W., Orwoll, E., Wu, F., Kaufman, J., Wang, Y., Lapauw, B., et al. (2017). Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe. JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 102(4), 1161–1173.
Vancouver
1.
Travison TG, Vesper HW, Orwoll E, Wu F, Kaufman J, Wang Y, et al. Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in the United States and Europe. JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM. 2017;102(4):1161–73.
MLA
Travison, Thomas G, Hubert W Vesper, Eric Orwoll, et al. “Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe.” JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM 102.4 (2017): 1161–1173. Print.