Reproducibility of Elecsys® Anti-TSHR Test Results in a Lot-to-Lot Comparison

D. Hermsen; A. Eckstein; S. Schinner; H. S. Willenberg; A. Thiel; W. A. Scherbaum; M. Schott

doi:10.1055/s-0029-1246188

Hormone and Metabolic Research, Table of Contents

Horm Metab Res 2010; 42(4): 295-297
DOI: 10.1055/s-0029-1246188

Short Communication

Reproducibility of Elecsys^® Anti-TSHR Test Results in a Lot-to-Lot Comparison

D. Hermsen¹ , A. Eckstein² , S. Schinner³ , H. S. Willenberg³ , A. Thiel³ , W. A. Scherbaum³ , M. Schott³

¹Institute for Clinical Chemistry and Laboratory Diagnostics, University Hospital Düsseldorf, Germany
²Department of Ophthalmology, University Hospital Essen, Germany
³Department of Endocrinology, Diabetes and Rheumatology, University Hospital Düsseldorf, Germany

Abstract

Most recently, a new rapid and fully-automated TSH receptor autoantibody (TRAb) assay has been established. This assay system uses the M22 human monoclonal antibody for competing against the patient's TSH receptor autoantibodies (TRAb) to be detected. The aim of our present study was to compare the reproducibility of TRAb values based on measurements with different TSH receptor preparations in a lot-to-lot comparison. For TRAb values > 2 IU/l the relative differences ranged from −9.0 to +10.0%. The mean difference was 0.28 ± 8%. For TRAb values around the cutoff for positivity (1.75 IU/l) a higher range of relative differences from −20 up to +15% was obtained. The overall mean of differences was −0.8±14%. The data clearly demonstrate that the automated TRAb assay has a high stability in regard to TSH receptor preparations.

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Correspondence

M. SchottMD

Department of Endocrinology Diabetes and Rheumatology

University Hospital Düsseldorf

Moorenstraße 5

40225 Düsseldorf

Germany

Phone: +49 211 8117810

Fax: +49 211 8117860

Email: matthias.schott@med.uni-duesseldorf.de