Analytical Performance and Clinical Utility of a Bioassay for Thyroid-Stimulating Immunoglobulins
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- Johannes J. Leschik
- 1Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany
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- Tanja Diana
- 1Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany
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- Paul D. Olivo
- 2Diagnostic Hybrids, a Quidel Company, Athens, OH
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- Jochem König
- 3Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), Division Medical Biometry, Johannes Gutenberg University Medical Center, Mainz, Germany
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- Ulrike Krahn
- 3Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), Division Medical Biometry, Johannes Gutenberg University Medical Center, Mainz, Germany
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- Yunsheng Li
- 2Diagnostic Hybrids, a Quidel Company, Athens, OH
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- Michael Kanitz
- 1Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany
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- George J. Kahaly
- 1Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany
抄録
<jats:title>Abstract</jats:title> <jats:p>The analytical performance and the clinical utility of a thyrotropin receptor (TSHR)–stimulating immunoglobulin (TSI) bioassay were compared with those of a TSHR-binding inhibitory immunoglobulin (TBII) assay. Limits of detection (LoD) and quantitation (LoQ), assay cutoff, and the half-maximal effective concentration (EC50) were measured. Dilution analysis was performed in sera of hyperthyroid patients with Graves disease (GD) during antithyroid treatment (ATD). Titer was defined as the first dilution step at which measurement of TSI or TBII fell below the assay cutoff. The LoD, LoQ, cutoff, and EC50 of the bioassay were 251-, 298-, 814-, and 827-fold lower than for the TBII assay. There were 22%, 42%, 23%, and 14% more positive samples in the TSI bioassay at dilutions of 1:3, 1:9, 1:27, and 1:81 (P < .0001), respectively. Responders to ATD demonstrated marked differences in titers compared with nonresponders. The bioassay detected lower levels of TSHR autoantibodies, and the dilution analysis provided similar predictive values of both assays in GD.</jats:p>
収録刊行物
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- American Journal of Clinical Pathology
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American Journal of Clinical Pathology 139 (2), 192-200, 2013-02-01
Oxford University Press (OUP)
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キーワード
詳細情報 詳細情報について
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- CRID
- 1363670318609496832
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- ISSN
- 19437722
- 00029173
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- データソース種別
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- Crossref