| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
Special Feature |
Division of Endocrinology (C.W., R.S.S.), Department of Medicine, Harbor-UCLA Medical Center and Research and Education Institute, Torrance, California 90502; UCLA-Olympic Analytical Laboratory (D.H.C., B.S.), Los Angeles, California 90025; and Department of Pathology and Medicine (L.M.D.), Pennsylvania State University College of Medicine, H. S. Hershey Medical Center, Hershey, Pennsylvania 17033
Address all correspondence and requests for reprints to: Christina Wang, M.D., UCLA School of Medicine, General Clinical Research Center, Box 16, 1000 West Carson Street, Torrance, California 90502.
The diagnosis of male hypogonadism requires the demonstration of a low serum testosterone (T) level. We examined serum T levels in pedigreed samples taken from 62 eugonadal and 60 hypogonadal males by four commonly used automated immunoassay instruments (Roche Elecsys, Bayer Centaur, Ortho Vitros ECi and DPC Immulite 2000) and two manual immunoassay methods (DPC-RIA, a coated tube commercial kit, and HUMC-RIA, a research laboratory assay) and compared results with measurements performed by liquid chromatography-tandem mass spectrometry (LC-MSMS). Deming’s regression analyses comparing each of the test results with LC-MSMS showed slopes that were between 0.881 and 1.217. The interclass correlation coefficients were between 0.92 and 0.97 for all methods. Compared with the serum T concentrations measured by LC-MSMS, the DPC Immulite results were biased toward lower values (mean difference, -90 ± 9 ng/dl) whereas the Bayer Centaur data were biased toward higher values (mean difference, +99 ± 11 ng/dl) over a wide range of serum T levels. At low serum T concentrations (<100 ng/dl or 3.47 nmol/liter), HUMC-RIA overestimated serum T, Ortho Vitros ECi underestimated the serum T concentration, whereas the other two methods (DPC-RIA and Roche Elecsys) showed differences in both directions compared with LC-MSMS. Over 60% of the samples (with T levels within the adult male range) measured by most automated and manual methods were within ± 20% of those reported by LC-MSMS. These immunoassays are capable of distinguishing eugonadal from hypogonadal males if adult male reference ranges have been established in each individual laboratory. The lack of precision and accuracy, together with bias of the immunoassay methods at low serum T concentrations, suggests that the current methods cannot be used to accurately measure T in females or serum from prepubertal subjects.
This work was supported by the Core Endocrine Laboratory at Penn State-Hershey Medical Center; National Institutes of Health (NIH) Grant MO1 RR00543 to the GCRC at Harbor-UCLA Medical Center; NIH Grants RO1 CA 71053 and RO1 DK 61006 (to C.W., D.H.C., and R.S.S.); and United States Anti-Doping Agency (to D.H.C.). The samples were collected by the nurses of the Harbor-UCLA GCRC, supported by NIH Grant MO1 RR00425.
Abbreviations: CV, Coefficient of variation; GC, gas chromatograph; HRP, horseradish peroxidase; HUMC, Harbor-UCLA Research and Education Institute Endocrine Research Laboratory; LC-MSMS, liquid chromatography-tandem mass spectrometry; LOQ, limit of quantification; MS, mass spectrometry; T, testosterone.
This article has been cited by other articles:
 |
|
 |
|
  L. M. Thienpont, K. Van Uytfanghe, S. Blincko, C. S. Ramsay, H. Xie, R. C. Doss, B. G. Keevil, L. J. Owen, A. L. Rockwood, M. M. Kushnir, et al. State-of-the-Art of Serum Testosterone Measurement by Isotope Dilution-Liquid Chromatography- Tandem Mass Spectrometry Clin. Chem., August 1, 2008; 54(8): 1290 - 1297. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. H Abbott, D. K Barnett, J. E Levine, V. Padmanabhan, D. A Dumesic, S. Jacoris, and A. F Tarantal Endocrine Antecedents of Polycystic Ovary Syndrome in Fetal and Infant Prenatally Androgenized Female Rhesus Monkeys Biol Reprod, July 1, 2008; 79(1): 154 - 163. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. A. Martin, R. J. Chang, D. A. Ehrmann, L. Ibanez, R. A. Lobo, R. L. Rosenfield, J. Shapiro, V. M. Montori, and B. A. Swiglo Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline J. Clin. Endocrinol. Metab., April 1, 2008; 93(4): 1105 - 1120. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. S. Swerdloff and C. Wang Free Testosterone Measurement by the Analog Displacement Direct Assay: Old Concerns and New Evidence Clin. Chem., March 1, 2008; 54(3): 458 - 460. [Full Text] [PDF]
|
|
|
|
 |
|
 P. Roy, M. Alevizaki, and I. Huhtaniemi In vitro bioassays for androgens and their diagnostic applications Hum. Reprod. Update, January 1, 2008; 14(1): 73 - 82. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. B. Araujo, G. R. Esche, V. Kupelian, A. B. O'Donnell, T. G. Travison, R. E. Williams, R. V. Clark, and J. B. McKinlay Prevalence of Symptomatic Androgen Deficiency in Men J. Clin. Endocrinol. Metab., November 1, 2007; 92(11): 4241 - 4247. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. Wang, P. Christenson, and R. Swerdloff Clinical Relevance of Racial and Ethnic Differences in Sex Steroids J. Clin. Endocrinol. Metab., July 1, 2007; 92(7): 2433 - 2435. [Full Text] [PDF]
|
|
|
|
|
|
T. L. Nielsen, C. Hagen, K. Wraae, K. Brixen, P. H. Petersen, E. Haug, R. Larsen, and M. Andersen Visceral and Subcutaneous Adipose Tissue Assessed by Magnetic Resonance Imaging in Relation to Circulating Androgens, Sex Hormone-Binding Globulin, and Luteinizing Hormone in Young Men J. Clin. Endocrinol. Metab., July 1, 2007; 92(7): 2696 - 2705. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. J Santen, N. F Boyd, R. T Chlebowski, S. Cummings, J. Cuzick, M. Dowsett, D. Easton, J. F Forbes, T. Key, S. E Hankinson, et al. Critical assessment of new risk factors for breast cancer: considerations for development of an improved risk prediction model Endocr. Relat. Cancer, June 1, 2007; 14(2): 169 - 187. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. B Yeap, O. P Almeida, Z. Hyde, P. E Norman, S A P. Chubb, K. Jamrozik, and L. Flicker In men older than 70 years, total testosterone remains stable while free testosterone declines with age. The Health in Men Study Eur. J. Endocrinol., May 1, 2007; 156(5): 585 - 594. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. K. Miller, E. A. Lawson, V. Mathur, T. L. Wexler, E. Meenaghan, M. Misra, D. B. Herzog, and A. Klibanski Androgens in Women with Anorexia Nervosa and Normal-Weight Women with Hypothalamic Amenorrhea J. Clin. Endocrinol. Metab., April 1, 2007; 92(4): 1334 - 1339. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. S. Legro A 27-Year-Old Woman With a Diagnosis of Polycystic Ovary Syndrome JAMA, February 7, 2007; 297(5): 509 - 519. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. Rosner, R. J. Auchus, R. Azziz, P. M. Sluss, and H. Raff Utility, Limitations, and Pitfalls in Measuring Testosterone: An Endocrine Society Position Statement J. Clin. Endocrinol. Metab., February 1, 2007; 92(2): 405 - 413. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R.I. McLachlan, E. Rajpert-De Meyts, C.E. Hoei-Hansen, D.M. de Kretser, and N.E. Skakkebaek Histological evaluation of the human testis--approaches to optimizing the clinical value of the assessment: Mini Review Hum. Reprod., January 1, 2007; 22(1): 2 - 16. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Chen, M. R. Sowers, F. M. Moran, D. S. McConnell, N. A. Gee, G. A. Greendale, C. Whitehead, S. E. Kasim-Karakas, and B. L. Lasley Circulating Bioactive Androgens in Midlife Women J. Clin. Endocrinol. Metab., November 1, 2006; 91(11): 4387 - 4394. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. E. Wierman, R. Basson, S. R. Davis, S. Khosla, K. K. Miller, W. Rosner, and N. Santoro Androgen Therapy in Women: An Endocrine Society Clinical Practice Guideline J. Clin. Endocrinol. Metab., October 1, 2006; 91(10): 3697 - 3710. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. de Ronde, Y. T. van der Schouw, H. A.P. Pols, L. J.G. Gooren, M. Muller, D. E. Grobbee, and F. H. de Jong Calculation of Bioavailable and Free Testosterone in Men: A Comparison of 5 Published Algorithms Clin. Chem., September 1, 2006; 52(9): 1777 - 1784. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Bhasin, G. R. Cunningham, F. J. Hayes, A. M. Matsumoto, P. J. Snyder, R. S. Swerdloff, and V. M. Montori Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline J. Clin. Endocrinol. Metab., June 1, 2006; 91(6): 1995 - 2010. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Tucker Cost Savings and Luteinizing Hormone-Releasing Hormone Agonist J. Oncol. Pract, May 1, 2006; 2(3): 103 - 103. [Full Text] [PDF]
|
|
|
|
|
|
D. J. Handelsman The Rationale for Banning Human Chorionic Gonadotropin and Estrogen Blockers in Sport J. Clin. Endocrinol. Metab., May 1, 2006; 91(5): 1646 - 1653. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. L. Ding, Y. Song, V. S. Malik, and S. Liu Sex Differences of Endogenous Sex Hormones and Risk of Type 2 Diabetes: A Systematic Review and Meta-analysis JAMA, March 15, 2006; 295(11): 1288 - 1299. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. C. Y. Tong, C.-S. Ho, V. T. F. Yeung, M. C. Y. Ng, W.-Y. So, R. Ozaki, G. T. C. Ko, R. C. W. Ma, E. Poon, N. N. Chan, et al. Association of Testosterone, Insulin-Like Growth Factor-I, and C-Reactive Protein with Metabolic Syndrome in Chinese Middle-Aged Men with a Family History of Type 2 Diabetes J. Clin. Endocrinol. Metab., December 1, 2005; 90(12): 6418 - 6423. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Sikaris, R. I. McLachlan, R. Kazlauskas, D. de Kretser, C. A. Holden, and D. J. Handelsman Reproductive Hormone Reference Intervals for Healthy Fertile Young Men: Evaluation of Automated Platform Assays J. Clin. Endocrinol. Metab., November 1, 2005; 90(11): 5928 - 5936. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. M. Kaufman and A. Vermeulen The Decline of Androgen Levels in Elderly Men and Its Clinical and Therapeutic Implications Endocr. Rev., October 1, 2005; 26(6): 833 - 876. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Bhasin Female Androgen Deficiency Syndrome--An Unproven Hypothesis J. Clin. Endocrinol. Metab., August 1, 2005; 90(8): 4970 - 4972. [Full Text] [PDF]
|
|
|
|
|
|
M. L. Cawood, H. P. Field, C. G. Ford, S. Gillingwater, A. Kicman, D. Cowan, and J. H. Barth Testosterone Measurement by Isotope-Dilution Liquid Chromatography-Tandem Mass Spectrometry: Validation of a Method for Routine Clinical Practice Clin. Chem., August 1, 2005; 51(8): 1472 - 1479. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. Pitteloud, V. K. Mootha, A. A. Dwyer, M. Hardin, H. Lee, K.-F. Eriksson, D. Tripathy, M. Yialamas, L. Groop, D. Elahi, et al. Relationship Between Testosterone Levels, Insulin Sensitivity, and Mitochondrial Function in Men Diabetes Care, July 1, 2005; 28(7): 1636 - 1642. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. A. Titus, M. J. Schell, F. B. Lih, K. B. Tomer, and J. L. Mohler Testosterone and Dihydrotestosterone Tissue Levels in Recurrent Prostate Cancer Clin. Cancer Res., July 1, 2005; 11(13): 4653 - 4657. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. P Ly and D. J Handelsman Empirical estimation of free testosterone from testosterone and sex hormone-binding globulin immunoassays Eur. J. Endocrinol., March 1, 2005; 152(3): 471 - 478. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. I. McLachlan and C. A. Allan Defining the Prevalence and Incidence of Androgen Deficiency in Aging Men: Where Are the Goal Posts? J. Clin. Endocrinol. Metab., December 1, 2004; 89(12): 5916 - 5919. [Full Text] [PDF]
|
|
|
|
|
|
T. Bassindale, D. A. Cowan, S. Dale, A. J. Hutt, A. R. Leeds, M. J. Wheeler, and A. T. Kicman Effects of Oral Administration of Androstenedione on Plasma Androgens in Young Women Using Hormonal Contraception J. Clin. Endocrinol. Metab., December 1, 2004; 89(12): 6030 - 6038. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C.A. Williams, M.R. Wallace, K.C. Drury, S. Kipersztok, R.K. Edwards, R.S. Williams, M.J. Haller, D.A. Schatz, J.H. Silverstein, B.A. Gray, et al. Blood lymphocyte chimerism associated with IVF and monochorionic dizygous twinning: Case report Hum. Reprod., December 1, 2004; 19(12): 2816 - 2821. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Van Uytfanghe, D. Stockl, J. M. Kaufman, T. Fiers, H. A. Ross, A. P. De Leenheer, and L. M. Thienpont Evaluation of a Candidate Reference Measurement Procedure for Serum Free Testosterone Based on Ultrafiltration and Isotope Dilution-Gas Chromatography-Mass Spectrometry Clin. Chem., November 1, 2004; 50(11): 2101 - 2110. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. M. Adams, A. E. Taylor, W. F. Crowley Jr., and J. E. Hall Polycystic Ovarian Morphology with Regular Ovulatory Cycles: Insights into the Pathophysiology of Polycystic Ovarian Syndrome J. Clin. Endocrinol. Metab., September 1, 2004; 89(9): 4343 - 4350. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. M. de Kretser Is Spermatogenic Damage Associated with Leydig Cell Dysfunction? J. Clin. Endocrinol. Metab., July 1, 2004; 89(7): 3158 - 3160. [Full Text] [PDF]
|
|
|
|
 |
|
 Testosterone in Older Men: Replay of the Estrogen Story? Journal Watch Gastroenterology, April 27, 2004; 2004(427): 6 - 6. [Full Text]
|
|
|
|
 |
|
 Testosterone in Older Men: Replay of the Estrogen Story? Journal Watch Psychiatry, April 7, 2004; 2004(407): 8 - 8. [Full Text]
|
|
|
|
 |
|
 Testosterone in Older Men: Replay of the Estrogen Story? Journal Watch (General), March 5, 2004; 2004(305): 2 - 2. [Full Text]
|
|
|
|
|
|
A. M. Matsumoto and W. J. Bremner Serum Testosterone Assays--Accuracy Matters J. Clin. Endocrinol. Metab., February 1, 2004; 89(2): 520 - 524. [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| Endocrinology | Endocrine Reviews | J. Clin. End. & Metab. |
| Molecular Endocrinology | Recent Prog. Horm. Res. | All Endocrine Journals |
