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Clinical Chemistry, Vol 42, 749-755, Copyright © 1996 by American Association for Clinical Chemistry
RL Fitzgerald and DA Herold
VA Medical Center, San Diego, CA 92161, USA. rlfitzgerald@vapop.ucsd.edu
We have developed an electron capture negative chemical ionization gas chromatography-mass spectrometry (GC-MS) procedure to quantify serum testosterone in the clinically relevant range 0.69-69.3 nmol/L and used this procedure to assess Ciba Corning Diagnostics ACS:180 testosterone immunoassay. The GC-MS method involves liquid-liquid extraction of serum samples and synthesis of a pentafluorobenzyloxime/silyl ether derivative of testosterone with excellent chromatographic and electron capturing properties. The ACS testosterone assay is the first fully automated nonradioactive testosterone immunoassay approved by the US Food and Drug Administration. Patients' specimens (101, 57 males, 44 females) were analyzed by both techniques. A plot of the GC-MS (x) vs ACS (y) testosterone concentrations for men was linear (y = 1.07x + 0.19 nmol/L), showing excellent correlation (r2 = 0.98) between the two assays. Agreement of the two assays for female specimens was poor (y = 0.72x + 1.2 nmol/L), with a poor correlation (r2 = 0.31).
The following articles in journals at HighWire Press have cited this article:
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P. Y. Liu, P. Y. Takahashi, P. D. Roebuck, and J. D. Veldhuis Age or Factors Associated with Aging Attenuate Testosterone's Concentration-Dependent Enhancement of the Regularity of Luteinizing Hormone Secretion in Healthy Men J. Clin. Endocrinol. Metab., October 1, 2006; 91(10): 4077 - 4084. [Abstract] [Full Text] [PDF]
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M. M. Kushnir, A. L. Rockwood, W. L. Roberts, E. G. Pattison, A. M. Bunker, R. L. Fitzgerald, and A. W. Meikle Performance Characteristics of a Novel Tandem Mass Spectrometry Assay For Serum Testosterone Clin. Chem., January 1, 2006; 52(1): 120 - 128. [Abstract] [Full Text] [PDF]
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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]
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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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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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D. A. Herold and R. L. Fitzgerald Immunoassays for Testosterone in Women: Better than a Guess? Clin. Chem., August 1, 2003; 49(8): 1250 - 1251. [Full Text] [PDF]
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J. Taieb, B. Mathian, F. Millot, M.-C. Patricot, E. Mathieu, N. Queyrel, I. Lacroix, C. Somma-Delpero, and P. Boudou Testosterone Measured by 10 Immunoassays and by Isotope-Dilution Gas Chromatography-Mass Spectrometry in Sera from 116 Men, Women, and Children Clin. Chem., August 1, 2003; 49(8): 1381 - 1395. [Abstract] [Full Text] [PDF]
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 P. C. Kao, D. A. Machacek, M. J. Magera, J. M. Lacey, and P. Rinaldo Diagnosis of Adrenal Cortical Dysfunction by Liquid Chromatography-Tandem Mass Spectrometry Ann. Clin. Lab. Sci., April 1, 2001; 31(2): 199 - 204. [Abstract] [Full Text] [PDF]
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M. Sanchez-Carbayo, M. Mauri, R. Alfayate, C. Miralles, and F. Soria Elecsys Testosterone Assay Evaluated Clin. Chem., August 1, 1998; 44(8): 1744 - 1746. [Full Text] [PDF]
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P. Luppa, C. Bruckner, I. Schwab, S. Hauck, S. Schmidmayr, C. Birkmayer, B. Paulus, and H. Hauptmann 7{alpha}-Biotinylated testosterone derivatives as tracers for a competitive chemiluminescence immunoassay of testosterone in serum Clin. Chem., December 1, 1997; 43(12): 2345 - 2352. [Abstract] [Full Text] [PDF]
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F. H. Wians Jr., J. Stuart, R. L. Fitzgerald, and D. A. Herold Ciba Corning ACS:180 Direct Total Testosterone Assay Can Be Used on Female Sera • The authors of the report referred to reply: Clin. Chem., August 1, 1997; 43(8): 1466 - 1468. [Full Text]
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Y.-S. Leung, K. Dees, R. Cyr, I. Schloegel, and P. C. Kao Falsely Increased Serum Estradiol Results Reported in Direct Estradiol Assays Clin. Chem., July 1, 1997; 43(7): 1250 - 1251. [Full Text]
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