Testosterone Measured by 10 Immunoassays and by Isotope-Dilution Gas Chromatography–Mass Spectrometry in Sera from 116 Men, Women, and Children

Author:

Taieb Joëlle1,Mathian Bruno2,Millot Françoise3,Patricot Marie-Claude2,Mathieu Elisabeth4,Queyrel Nicole5,Lacroix Isabelle6,Somma-Delpero Claude7,Boudou Philippe8

Affiliation:

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

Abstract

Abstract 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.

Publisher

Oxford University Press (OUP)

Subject

Biochemistry, medical,Clinical Biochemistry

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