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Clinical Chemistry 50: 778-a, 2004; 10.1373/clinchem.2004.032128
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(Clinical Chemistry. 2004;50:778.)
© 2004 American Association for Clinical Chemistry, Inc.

Letters to the Editor

Reliability of Extraction/Chromatography RIAs: Response

David A. Herold1,a and Robert L. Fitzgerald1

1 VA San Diego Healthcare System and University of California, San Diego, San Diego, CA

aAuthor for correspondence. E-mail dherold{at}ucsd.edu.


To the Editor:

It is clear from the above letter by Stanczyk that he agrees with Taieb et al. (1) and Herold and Fitzgerald (2)(3) that commercially available immunoassays cannot be used for the determination of serum testosterone in women. Nonetheless, based on his comparison with four direct testosterone immunoassay methods, Stanczyk proposes that a RIA, rehabilitated with organic solvent extraction and Celite column partition chromatography, could be used as a "gold standard" (4).

Stanczyk misses our point. We have pointed out previously the fallacy of validating an immunoassay with an immunoassay (5). Stanczyk shows no data comparing the extraction/chromatography RIA with an independent chemical technique (4). The message of our editorial is that any immunoassay, with or without an extraction and a purification step, requires validation by a definitive or reference method before being considered a gold standard (2).

We have not made an arbitrary statement that extraction/chromatography RIAs for testosterone do not work. Our point is that there are no convincing data showing that they do work. The only existing reports, from two independent sources (1)(5), that compared extraction/chromatography RIA with gas chromatography–mass spectrometry show that there are considerable problems with these analyses. Until an extraction/chromatography RIA has been properly validated the results generated from such tests are subject to question.

We appreciate the opportunity to further emphasize the need for proper validation of steroid immunoassays.


References

  1. Taieb J, Mathian B, Millot F, Patricot M-C, Mathieu E, Queyrel N, et al. Testosterone measured by 10 immunoassays and by isotope-dilution gas chromatography–mass spectrometry in sera from 116 men, women and children. Clin Chem 2003;49:1381-1395.[Abstract/Free Full Text]
  2. Herold DA, Fitzgerald RL. Immunoassays for testosterone in women: better than a guess?. Clin Chem 2003;49:1250-1251.[Free Full Text]
  3. Fitzgerald RL, Herold DA. Serum total testosterone. Immunoassay compared with negative chemical ionization gas chromatography-mass spectrometry. Clin Chem 1996;42:749-755.[Abstract/Free Full Text]
  4. Stanczyk FZ, Cho MM, Endres DB, Morrison JL, Patel S, Paulson RJ. Limitations of direct estradiol and testosterone immunoassay kits. Steroids 2003;68:1173-8.[CrossRef][Web of Science][Medline] [Order article via Infotrieve]
  5. Wians FH, Jr, Stuart J, Fitzgerald RL, Herold DA. Ciba Corning ACS:180 Direct total testosterone assay can be used on female sera. Clin Chem 1997;43:1466-1468.[Free Full Text]



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F. Z. Stanczyk
Extraction/Chromatographic Testosterone RIA Can Be Used as the "Gold Standard" for Determining the Reliability of Direct Testosterone Immunoassay Measurements
Clin. Chem., November 1, 2004; 50(11): 2219 - 2220.
[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]

This Article
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Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Web of Science (3)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Herold, D. A.
Right arrow Articles by Fitzgerald, R. L.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Herold, D. A.
Right arrow Articles by Fitzgerald, R. L.
Related Collections
Right arrow Current Issues in Laboratory Medicine
Right arrow Endocrinology and Metabolism

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