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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

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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

Marijke Reynders1 / Ellen Anckaert2 / Johan Schiettecatte3 / Johan Smitz4

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

Citation Information: Clinical Chemical Laboratory Medicine. Volume 43, Issue 1, Pages 86–89, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2005.013, January 2005

Publication History

Received:
April 22, 2004
Accepted:
October 7, 2004

Abstract

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 0.74 nmol/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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