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Horm Metab Res 2010; 42(12): 900-902
DOI: 10.1055/s-0030-1267171
Short Communication

© Georg Thieme Verlag KG Stuttgart · New York

Continuously Increasing Sensitivity over Three Generations of TSH Receptor Autoantibody Assays

K. Zöphel1 , [*] , D. Roggenbuck2 , [*] , G. Wunderlich1 , M. Schott3
  • 1Department of Nuclear Medicine, Medical Faculty “Carl Gustav Carus”, University of Technology Dresden, Germany
  • 2GA Generic Assays GmbH, Dahlewitz, Berlin, Germany
  • 3Department of Endocrinology, Diabetes and Rheumatology, University Hospital Duesseldorf, Duesseldorf, Germany
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Publikationsverlauf

received 03.07.2010

accepted 08.09.2010

Publikationsdatum:
05. Oktober 2010 (online)

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Abstract

Thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (TRAb) are the hallmarks in serological diagnosis of Graves’ disease (GD, autoimmune hyperthyroidism). In the 1980s, the first generation liquid-phase TRAb assay with detergent solubilized porcine TSHR was introduced into routine thyroid serology and proved to be highly specific for GD, albeit with moderate sensitivity. In the 1990s, second generation solid-phase TRAb assays with immobilized porcine or recombinant human TSHR became available, and were clearly more sensitive for Graves’ disease without loss of specificity. Recently, third generation TRAb assays have been developed, in which the human thyroid stimulating monoclonal antibody M22 replaces bovine TSH as the competing reagent for TRAb binding to TSHR. Again, an improvement in functional sensitivity was reported for this latest assay generation. To investigate the analytical (aas) and functional assay sensitivity (fas) over 3 generations of TRAb assays, pooled serum samples from patients with GD were measured 10-fold in different assay lots over a few months. The 20% inter-assay coefficients of variation (CV) were calculated and compared taking into account the different calibrations of the assay generations. The fas continuously increased from about 8 U/l of MRC B65/122 in liquid phase TRAb assays, to about 1.0 IU/l (NIBSC 90/672) in TSH based solid phase TRAb assays and to about 0.3 IU/l (NIBSC 90/672) in the M22 based TRAb assay finally. In conclusion, the fas of TRAb measurements has been improved continuously over the last 3 decades.

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1 KZ und DR contributed equally to this study.

Correspondence

K. ZöphelMD 

Department of Nuclear

Medicine

Carl Gustav Carus Medical

School

University of Technology

Dresden

Fetscherstraße 74

01307 Dresden

Germany

Telefon: +49/351/458 13879

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eMail: klaus.zoephel@uniklinikum-dresden.de