Estimating testosterone concentrations in adolescent girls: Comparison of two direct immunoassays to liquid chromatography-tandem mass spectrometry
Open accessAbstract
Context The appropriate role of direct total testosterone (T) immunoassays in reproductive research is controversial.Objective To assess the concordance between two direct immunoassays and a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for total T in adolescent girls with measured concentrations < 50 ng/dl.Design Cross-sectional analysis.Setting Academic medical center.Participants Adolescent girls (age 8.4-18.1 years) participating in clinical research protocols.Intervention Paired blood samples were obtained for total T by LC-MS/MS (n = 66; Mayo Clinic Laboratory) and by direct immunoassay (Center for Research in Reproduction)-either radioimmunoassay (RIA; n = 31) or chemiluminescence immunoassay (CLIA; n = 35). At the time of assay, laboratories were unaware that results would be compared.Main outcome measure Measurement agreement between immunoassay and LC-MS/MS.Results Measured T concentrations (LC-MS/MS) were <7 to 44 ng/dl. The average difference between RIA and LC-MS/MS was 0.84 [-0.89, 2.56] ng/dl (mean [95% confidence interval]). RIA correlated very strongly with LC-MS/MS (r = 0.899; p < 0.0001); and both Deming regression and Bland-Altman analysis suggested no bias. The average difference between chemiluminescence and LC-MS/MS was 1.39 [-0.83, 3.60] ng/dl. CLIA correlated strongly with LC-MS/MS (r = 0.806; p < 0.0001). While Bland-Altman analysis suggested no systematic bias, Deming regression analysis suggested that, as measured values increased, values obtained by CLIA tended to be progressively, albeit only modestly, higher than those obtained by LC-MS/MS.Conclusions These data support the use of rigorously-performed and carefully-validated direct T immunoassays in high-quality endocrine research in peripubertal adolescent girls.
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Testosterone concentrations measured by CLIA on the Immulite 2000 system tended to be higher than those obtained by LC-MS/MS.
“Testosterone concentrations measured by CLIA on the Immulite 2000 system (Siemens) tended to be higher than those obtained by LC-MS/MS [20].”
From Clinical Usefulness of Ultraperformance Liquid Chromatography-Tandem Mass Spectrometry Method for Low Serum Testosterone Measurement (2023) · cites this paper as [20]
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STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT
Martin Bland, J., & Altman, D. (1986) · The Lancet · doi:10.1016/s0140-6736(86)90837-8 · Cited by 47,965 · see citing works
Beckett, A. H., Rowland, M., & TURNER, P. (1965) · The Lancet · doi:10.1016/s0140-6736(65)91037-8 · Cited by 16,917 · see citing works
Understanding bland altman analysis
Giavarina, D. (2015) · Biochemia Medica · doi:10.11613/bm.2015.015 · Cited by 4,022 · see citing works
Rosner, W., Auchus, R. J., Azziz, R., Sluss, P. M., & Raff, H. (2007) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2006-1864 · Cited by 1,176 · see citing works
Taieb, J., Mathian, B., Millot, F., Patricot, M. C., Mathieu, E., Queyrel, N., Lacroix, I., Somma-Delpéro, C., & Boudou, P. (2003) · Clinical Chemistry · doi:10.1373/49.8.1381 · Cited by 638 · see citing works
Wang, C., Catlin, D. H., Demers, L. M., Starcevic, B., & Swerdloff, R. S. (2004) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2003-031287 · Cited by 580 · see citing works
Incorrect least-squares regression coefficients in method-comparison analysis.
Cornbleet, P. J., & Gochman, N. (1979) · Clinical Chemistry · doi:10.1093/clinchem/25.3.432 · Cited by 573 · see citing works
Handelsman, D. J., & Wartofsky, L. (2013) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2013-3375 · Cited by 368 · see citing works
Legro, R. S., Schlaff, W. D., Diamond, M. P., Coutifaris, C., Casson, P. R., Brzyski, R. G., Christman, G. M., Trussell, J. C., Krawetz, S. A., Snyder, P. J., et al. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2010-1123 · Cited by 213 · see citing works
Vesper, H. W., Bhasin, S., Wang, C., Tai, S. S., Dodge, L. A., Singh, R. J., Nelson, J., Ohorodnik, S., Clarke, N. J., Salameh, W. A., et al. (2009) · Steroids · doi:10.1016/j.steroids.2009.01.004 · Cited by 152 · see citing works
Steroid Assays and Endocrinology: Best Practices for Basic Scientists
Auchus, R. J. (2014) · Endocrinology · doi:10.1210/en.2014-7534 · Cited by 67 · see citing works
Mass spectrometry, immunoassay and valid steroid measurements in reproductive medicine and science
Handelsman, D. J. (2017) · Human Reproduction · doi:10.1093/humrep/dex078 · Cited by 58 · see citing works
Editorial:The New Instructions to Authors for the Reporting of Steroid Hormone Measurements
Wierman, M. E., Auchus, R. J., Haisenleder, D. J., Hall, J. E., Handelsman, D. J., Hankinson, S. E., Rosner, W., Singh, R., Sluss, P. M., & Stanczyk, F. Z. (2014) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2014-3424 · Cited by 46 · see citing works
Self-citationEditorial: The New Instructions to Authors for the Reporting of Steroid Hormone Measurements
Wierman, M. E., Auchus, R. J., Haisenleder, D. J., Hall, J. E., Handelsman, D. J., Hankinson, S. E., Rosner, W., Singh, R., Sluss, P. M., & Stanczyk, F. Z. (2014) · Endocrine Reviews · doi:10.1210/er.2014-1067 · Cited by 38 · see citing works
Self-citationPre-analytical issues for testosterone and estradiol assays
Raff, H., & Sluss, P. M. (2008) · Steroids · doi:10.1016/j.steroids.2008.05.005 · Cited by 34 · see citing works
Ankarberg‐Lindgren, C., & Norjavaara, E. (2015) · Scandinavian Journal of Clinical and Laboratory Investigation · doi:10.3109/00365513.2014.942694 · Cited by 32 · see citing works
Mouritsen, A., Søeborg, T., Johannsen, T. H., Aksglæde, L., Sørensen, K., Hagen, C. P., Mieritz, M. G., Frederiksen, H. W., Andersson, A., & Juul, A. (2014) · Hormone Research in Paediatrics · doi:10.1159/000358560 · Cited by 31 · see citing works
Kim, S., Lundgren, J. A., Bhabhra, R., Collins, J. S., Patrie, J., Burt-Solorzano, C. M., Marshall, J., & McCartney, C. (2018) · Journal of Clinical Endocrinology and Metabolism · doi:10.1210/jc.2017-02299 · Cited by 13 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Reproductive Endocrinology Reference Intervals for Transgender Women on Stable Hormone Therapy
Greene, D. N., Schmidt, R. L., Winston‐McPherson, G. N., Rongitsch, J., Imborek, K. L., Dickerson, J. A., Drees, J. C., Humble, R. M., Nisly, N. L., Dole, N. J., et al. (2020) · The Journal of Applied Laboratory Medicine · doi:10.1093/jalm/jfaa028 · Cited by 36 · see citing works
Shiraishi, K., Oka, S., & Matsuyama, H. (2020) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaa860 · Cited by 26 · see citing works
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Esquivel-Zuniga, M. R., Kirschner, C. K., McCartney, C. R., & Solorzano, C. M. B. (2022) · Seminars in Reproductive Medicine · doi:10.1055/s-0041-1742259 · Cited by 23 · see citing works
Self-citationWagner, I. V., Savchuk, I., Sahlin, L., Kulle, A. E., Klöting, N., Dietrich, A., Holterhus, P.-M., Dötsch, J., Blüher, M., & Söder, O. (2022) · Obesity Facts · doi:10.1159/000521571 · Cited by 20 · see citing works
Huang, S., & Feng, R. (2024) · Alexandria Engineering Journal · doi:10.1016/j.aej.2024.04.054 · Cited by 17 · see citing works
Martínez-Escribano, A., Maroto-García, J., Ruiz-Galdón, M., Barrios-Rodríguez, R., Álvarez-Millán, J. J., Cabezas-Sánchez, P., Plaza-Andrades, I., Molina-Vega, M., Tinahones, F. J., Queipo-Ortuño, M. I., et al. (2020) · Biomolecules · doi:10.3390/biom10121697 · Cited by 11 · see citing works
Cho, S.-E., Han, J., Park, J.-H., Park, E., Kim, G. Y., Lee, J. H., Yi, A., Lee, S. G., Lee, E. H., & Yun, Y.-M. (2023) · Annals of Laboratory Medicine · doi:10.3343/alm.2023.43.1.19 · Cited by 3 · see citing works
Houghton, M. A., McCartney, C. R., Kim, S. H., Patrie, J. T., Marshall, J. C., & Solorzano, C. M. B. (2025) · Journal of the Endocrine Society · doi:10.1210/jendso/bvaf154 · Cited by 1 · see citing works
Self-citationAndrogen-Secreting Adrenal Adenoma in a Postmenopausal Woman as a Cause of Hirsutism
Bermúdez-Silva, L. N., Buell‐Acosta, J. D., León-Cárdenas, L. A., & Franco, J. J. P. (2025) · JCEM Case Reports · doi:10.1210/jcemcr/luaf250
- Authors
- McCartney, C. R., Burt Solorzano, C. M., Patrie, J. T., Marshall, J. C., & Haisenleder, D. J.
- Affiliations
- University of Virginia Medical Center (US)
- University of Virginia (US)
- University of Virginia Health System (US)
- Corresponding author
- McCartney, Christopher R.
- Venue
- Steroids
- Publisher
- Elsevier BV
- Published
- 2018-12
- Volume
- 140
- Pages
- 62-69
- ISSN
- 0039-128X (ISSN-L)
- PMC
- PMC7017602
- OpenAlex
- W2890337318
- Cited by
- 9
- References
- 18
- Citations by year
- 2025: 2 · 2024: 1 · 2022: 3 · 2020: 3
- FWCI
- 0.51
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Steroids (acceptedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
- Keywords
- total testosterone, direct immunoassay, radioimmunoassay, chemiluminescence immunoassay, liquid chromatography-tandem mass spectrometry, assay agreement, adolescent girls, peripubertal girls, androgen deficiency, endocrine research
- MeSH terms
- Adolescent, Child, Chromatography, Liquid, Female, Humans, Immunoassay, Testosterone, Tandem Mass Spectrometry
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