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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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Volume 43, Issue 1 (Jan 2005)


Evaluation of a new automated electrochemiluminescent sex hormone-binding globulin (SHBG) immunoassay

Marijke Reynders / Ellen Anckaert / Johan Schiettecatte / Johan Smitz
Published Online: 2011-09-21 | DOI: https://doi.org/10.1515/CCLM.2005.013


Serum sex hormone-binding globulin (SHBG) regulates the cellular bioavailability of SHBG-bound steroid hormones. Since variations in SHBG levels may affect the concentration of free, i.e., biologically active testosterone in serum, SHBG levels are commonly measured as a supplement to total testosterone determination. The recently developed electrochemiluminescence Elecsys ® SHBG immunoassay was evaluated analytically on a Modular E170 (Roche Diagnostics, Mannheim, Germany) immunoanalyzer. Major differences in SHBG concentrations have been described among the commercially available methods; we therefore compared the new method with an established SHBG immunoradiometric assay (IRMA) in 99 routine serum samples. To provide reference values to clinicians, SHBG concentration was measured by Elecsys ® in 304 serum samples from healthy volunteers and several relevant clinical subgroups. The within-run and total imprecision coefficients of variation were ≤2.9% and ≤3.3%, respectively. Functional sensitivity was at least 0.74nmol/L. Recoveries after dilution of high-concentration samples in low-titer human serum or in assay diluent were within the range of 85–110%. The Elecsys ® SHBG assay correlated well (r=0.98) with the SHBG immunoradiometric assay, but values were higher for the Elecsys ® assay (Passing Bablok regression analysis: slope 1.14, intercept +2.5). In healthy subjects and clinical subgroups, we confirmed the differences in SHBG values reported in the literature. The Elecsys ® SHBG immunoassay provides precision and reliability in combination with reduced turnaround time.

Keywords: immunoassay; sex hormone-binding globulin


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About the article

Corresponding author: Ellen Anckaert, RIA Laboratorium, Laarbeeklaan 101, 1090 Brussels, Belgium Phone: +32-2-4775057, Fax: +32-2-4775060,

Received: 2004-04-22

Accepted: 2004-10-07

Published Online: 2011-09-21

Published in Print: 2005-01-01

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2005.013.

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©2005 by Walter de Gruyter Berlin New York. Copyright Clearance Center

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