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Endocrinology and Metabolism |
1 Hormonology Laboratory, A. Béclère Hospital, 92141 Clamart, France.
2 Hormonology Laboratory, Lyon Sud Hospital, 69495 Lyon, France.
3 Biochemistry and Hormonology Laboratory, Tenon Hospital, 75020 Paris, France.
4 Biochemistry and Molecular Biology Laboratory, Angers Hospital, 49003 Angers, France.
5 Biochemistry Laboratory, Versailles Hospital, 78150 Le Chesnay, France.
6 CERBA Laboratory, 95066 Cergy Pontoise, France.
7 Nuclear Medicine Laboratory, Timone Hospital, 13385 Marseille, France.
8 Unit of Hormonal Biochemistry, St Louis Hospital, 75010 Paris, France.
aAddress correspondence to this author at: Unit of Hormonal Biochemistry, St Louis Hospital, Assistance-Publique-Hôpitaux de Paris, 1 avenue Claude Vellefaux 75010 Paris, France. Fax 33-1-42-49-42-80; e-mail philippe.boudou{at}sls.ap-hop-paris.fr.
Background: Commercially available testosterone immunoassays give divergent results, especially at the low concentrations seen in women. We compared immunoassays and a nonimmunochemical method that could quantify low testosterone concentrations.
Methods: We measured serum testosterone in 50 men, 55 women, and 11 children with use of eight nonisotopic immunoassays, two isotopic immunoassays, and isotope-dilution gas chromatography–mass spectrometry (ID/GC-MS).
Results: Compared with ID/GC-MS, 7 of the 10 immunoassays tested overestimated testosterone concentrations in samples from women; mean immunoassay results were 46% above those obtained by ID/GC-MS. The immunoassays underestimated testosterone concentrations in samples from men, giving mean results 12% below those obtained by ID/GC-MS. In women, at concentrations of 0.6–7.2 nmol/L, 3 of the 10 immunoassays gave positive mean differences >2.0 nmol/L (range, -0.7 to 3.3 nmol/L) compared with ID/GC-MS; in men at concentrations of 8.2–58 nmol/L, 3 of the 10 immunoassays tested gave mean differences >4.0 nmol/L (range, -4.8 to 2.6 nmol/L).
Conclusion: None of the immunoassays tested was sufficiently reliable for the investigation of sera from children and women, in whom very low (0.17 nmol/L) and low (<1.7 nmol/L) testosterone concentrations are expected.
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D. A. Herold and R. L. Fitzgerald Drs. Herold and Fitzgerald respond: Clin. Chem., November 1, 2004; 50(11): 2220 - 2221. [Full Text] [PDF]
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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]
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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]
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U.-H. Stenman Standardization of Assays for Human Chorionic Gonadotropin Clin. Chem., May 1, 2004; 50(5): 798 - 800. [Full Text] [PDF]
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F. Z. Stanczyk Reliability of Extraction/Chromatography RIAs Clin. Chem., April 1, 2004; 50(4): 778 - 778. [Full Text] [PDF]
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D. A. Herold and R. L. Fitzgerald Reliability of Extraction/Chromatography RIAs: Response Clin. Chem., April 1, 2004; 50(4): 778 - 778. [Full Text] [PDF]
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P. A. Torjesen, L. Sandnes, and P. Boudou Serum Testosterone in Women as Measured by an Automated Immunoassay and a RIA * Dr. Boudou responds for the authors of the article cited above: Clin. Chem., March 1, 2004; 50(3): 678 - 679. [Full Text] [PDF]
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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]
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C. Wang, D. H. Catlin, L. M. Demers, B. Starcevic, and R. S. Swerdloff Measurement of Total Serum Testosterone in Adult Men: Comparison of Current Laboratory Methods Versus Liquid Chromatography-Tandem Mass Spectrometry J. Clin. Endocrinol. Metab., February 1, 2004; 89(2): 534 - 543. [Abstract] [Full Text] [PDF]
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