Measurement of Free Testosterone in Normal Women and Women with Androgen Deficiency: Comparison of Methods (original) (raw)

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1Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School (K.K.M., J.H., G.S., A.K.) Boston, Massachusetts 02114

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2College of Physicians and Surgeons, Columbia University and St. Luke’s-Roosevelt Hospital Center (W.R.), New York, New York 10019

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3MGH Biostatistics Center and the Clinical Research Center, Massachusetts General Hospital and Harvard Medical School (H.L., D.S.), Boston, Massachusetts 02114

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1Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School (K.K.M., J.H., G.S., A.K.) Boston, Massachusetts 02114

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1Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School (K.K.M., J.H., G.S., A.K.) Boston, Massachusetts 02114

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3MGH Biostatistics Center and the Clinical Research Center, Massachusetts General Hospital and Harvard Medical School (H.L., D.S.), Boston, Massachusetts 02114

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4General Clinical Research Center, Massachusetts General Hospital and Harvard Medical School (G.N.), Boston, Massachusetts 02114

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1Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School (K.K.M., J.H., G.S., A.K.) Boston, Massachusetts 02114

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Accepted:

29 October 2003

Published:

01 February 2004

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Karen K. Miller, William Rosner, Hang Lee, Joan Hier, Gemma Sesmilo, David Schoenfeld, Gregory Neubauer, Anne Klibanski, Measurement of Free Testosterone in Normal Women and Women with Androgen Deficiency: Comparison of Methods, The Journal of Clinical Endocrinology & Metabolism, Volume 89, Issue 2, 1 February 2004, Pages 525–533, https://doi.org/10.1210/jc.2003-030680
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Androgen deficiency in women is increasingly recognized as a new clinical syndrome and has raised our awareness of the importance of accurate and well-validated measurements of serum free testosterone (T) concentrations in women. Therefore, we compared serum free T levels measured by equilibrium dialysis to those measured by a direct RIA (analog method) and to those calculated from the law of mass action (requires the measurement of total T and SHBG). We also calculated the free androgen index, 100 × T/SHBG, as a simple index known to correlate with free T. Subjects were 147 women with variable androgen and estrogen statuses. All were studied three times in 1 month and included women 1) with regular menses (estrogen positive, T positive), 2) more than 50 yr old and not receiving estrogen (estrogen negative, T positive), 3) receiving estrogen (estrogen positive, T negative), and 4) with severe androgen deficiency secondary to hypopituitarism (estrogen negative, T negative). Calculated values for free T using the laws of mass action correlated well with those obtained from equilibrium dialysis (r = 0.99; P < 0.0001). However, the agreement depended strongly on the specific assays used for total T and SHBG. In contrast, the direct RIA method had unacceptably high systematic bias and random variability and did not correlate as well with equilibrium dialysis values (r = 0.81; P < 0.0001). In addition, the lower limit of detection was higher for the direct RIA than for equilibrium dialysis or calculated free T. Free androgen index correlates well with free T by equilibrium dialysis (r = 0.93; P < 0.0001), but is a unitless number without reference to the physical reality of free T. We conclude that the mass action equation and equilibrium dialysis are the preferred methods for use in diagnosing androgen deficiency in women.

Copyright © 2004 by The Endocrine Society

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