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Tanja Diana Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Christian Wüster Endocrine Laboratory Prof. Wüster, Mainz, Germany

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Paul D. Olivo Department of Microbiology, Washington University, St. Louis, Missouri, USA

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Angelica Unterrainer Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Jochem König Endocrine Laboratory Prof. Wüster, Mainz, Germany

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Michael Kanitz Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Artur Bossowski Department of Pediatrics, Endocrinology, and Diabetology, Medical University of Byalistok, Bialystok, Poland

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Brigitte Decallonne Division of Clinical and Experimental Endocrinology, UZ Leuven, Leuven, Belgium

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George J. Kahaly Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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hypothyroidism [ 10 , 12 ]. TSHR Ab can be measured with either a bioassay or a binding assay. However, bioassays have the advantage of indicating not only the presence of Ab but also their functional activity and potency. Since no studies that compare the

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Tanja Diana Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Paul D. Olivo Department of Molecular Microbiology, Washington University Medical School, St. Louis, Missouri, USA

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Yie-Hwa Chang Mediomics, LLC, St. Louis, Missouri, USA

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Christian Wüster Endocrine Laboratory and Practice Prof. Wüster, Mainz, Germany

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Michael Kanitz Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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George J. Kahaly Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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yielded similar results. All samples were also measured with the Cobas binding assay and were TBII positive Fig. 2. Correlation of results of the luciferase and cAMP TSAb bioassays using serum from 33 untreated patients with GD. The Bridge-It cAMP

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George J. Kahaly Johannes Gutenberg University Medical Center, Mainz, Germany

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either via competitive-binding immunoassays or with bioassays [ 4 ]. Antibody-binding assays only report the presence or absence of TSHR-Ab and their concentrations, but do not indicate their functional activity. Bioassays, in contrast, indicate whether

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Inge Bülow Pedersen Department of Endocrinology and Medicine, Aalborg University Hospital, Aalborg, Denmark

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Peter Laurberg Department of Endocrinology and Medicine, Aalborg University Hospital, Aalborg, Denmark

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(Roche Modular System) used to test thyroid function in the newborn and how biotin in the sample may interfere. Fig. 1 Principles of the immunometric assay used for TSH measurement (upper panel), and the competitive binding assay used for the

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Tanja Diana Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Hans-Peter Holthoff AdvanceCor GmbH, Martinsried, Germany

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Julia Fassbender AdvanceCor GmbH, Martinsried, Germany

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Christian Wüster Endocrine Laboratory and Practice Prof. Wüster, Mainz, Germany

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Michael Kanitz Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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George J. Kahaly Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Martin Ungerer AdvanceCor GmbH, Martinsried, Germany

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the TSAb luciferase bioassay exhibits a higher sensitivity than the cAMP assay. We also demonstrated the relevance and clinical utility of measuring functional TSHR-Ab. The bridge immunoassay is a purely binding assay that utilizes a pair of

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Naohiro Araki Diagnostic Division, Otsuka Pharmaceutical Co. Ltd., Tokushima, Japan

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Mitsuru Iida Diagnostic Division, Otsuka Pharmaceutical Co. Ltd., Tokushima, Japan

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Nobuyuki Amino Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Shinji Morita Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Akane Ide Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Eijun Nishihara Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Mitsuru Ito Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Jun Saito Department of Medicine, Yokohama Rosai Hospital, Yokohama, Japan

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Tetsuo Nishikawa Department of Medicine, Yokohama Rosai Hospital, Yokohama, Japan

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Kiyonori Katsuragi Diagnostic Division, Otsuka Pharmaceutical Co. Ltd., Tokushima, Japan

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Akira Miyauchi Department of Internal Medicine, Kuma Hospital, Kobe, Japan

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Hashimoto's thyroiditis [ 3 ]. The amount of TSHR antibodies can be measured with competitive binding assays, the so-called thyrotropin-binding inhibitory immunoglobulin/TSHR antibodies (TRAb) assay, using either labeled thyroid-stimulating hormone (TSH

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Hirosuke Danno Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Eijun Nishihara Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Kazuyoshi Kousaka Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Tomohiko Nakamura Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Toshihiko Kasahara Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Takumi Kudo Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Mitsuru Ito Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Shuji Fukata Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Mitsushige Nishikawa Division of Internal Medicine, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Akira Miyauchi Division of Surgery and Director, Center for Excellence in Thyroid Care, Kuma Hospital, Kobe, Japan

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Graves’ disease and multinodular toxic goitre: a comparison of two competitive binding assays . Clin Endocrinol . 2001 Sep ; 55 ( 3 ): 381 – 90 . http://dx.doi.org/10.1046/j.1365-2265.2001.01347.x 36 Hiraiwa T , Ito M , Imagawa A

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Daniel Rathmann Institut für Experimentelle Endokrinologie, Charité-Universitätsmedizin Berlin, Berlin, Germany

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Eddy Rijntjes Institut für Experimentelle Endokrinologie, Charité-Universitätsmedizin Berlin, Berlin, Germany

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Julika Lietzow Institut für Experimentelle Endokrinologie, Charité-Universitätsmedizin Berlin, Berlin, Germany

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Josef Köhrle Institut für Experimentelle Endokrinologie, Charité-Universitätsmedizin Berlin, Berlin, Germany

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://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf. 18 Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R: Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding

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George J. Kahaly Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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Luigi Bartalena Department of Medicine and Surgery, University of Insubria, Varese, Italy

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Lazlo Hegedüs Department of Endocrinology and Metabolism, Odense University Hospital, Odense, Denmark

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Laurence Leenhardt Thyroid and Endocrine Tumors Unit, Pitié Salpêtrière Hospital, Sorbonne University, Paris, France

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Kris Poppe Endocrine Unit, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium

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Simon H. Pearce Department of Endocrinology, Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom

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with suspected Graves’ hyperthyroidism. TSH-R-Ab are specific biomarkers for GD [ 2 , 22 ]. Most immunoassays today use a competitive-binding assay and measure what are referred to as TSH-R binding inhibitory immunoglobulins (TBII). Binding

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Tomasz Bednarczuk Department of Internal Medicine and Endocrinology, Medical University of Warsaw, Warsaw, Poland

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Thomas H. Brix Department of Endocrinology and Metabolism, Odense University Hospital, Odense, Denmark

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Wolfgang Schima Department of Diagnostic and Interventional Radiology, Goettlicher Heiland Krankenhaus, Barmherzige Schwestern Krankenhaus, and Sankt Josef Krankenhaus, Vienna, Austria

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Georg Zettinig Schilddruesenpraxis Josefstadt, Vienna, Austria

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George J. Kahaly Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany

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.1400264 . 61 Pedersen IB , Knudsen N , Perrild H , Ovesen L , Laurberg P . TSH-receptor antibody measurement for differentiation of hyperthyroidism into Graves’ disease and multinodular toxic goitre: a comparison of two competitive binding

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