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Clinical efficacy of thyroid-stimulating immunoglobulin detection for diagnosing Graves’ disease and predictors of responsiveness to methimazole
Institution:1. Department of Endocrinology and Metabolism, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China;2. Department of Nuclear Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China;3. Department of Critical Care Medicine, Nanjing Hospital Affiliated to Nanjing University of Chinese Medicine, Nanjing 210003, China;1. Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, United States;2. Division of Cardiology, Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States;3. Division of Emergency Medicine, McMaster University, Hamilton, ON, Canada;4. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada;1. NICHE Research Group, Faculty of Computer Science, Dalhousie University, Halifax, NS, Canada;2. Department of Pathology and Laboratory Medicine, Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada;3. Division of Neurosurgery, Dalhousie University, Halifax, NS Canada;4. Division of Endocrinology, Dalhousie University, Halifax, NS Canada;1. Department of Pathology, University of Utah, Salt Lake City, UT, United States;2. ARUP Laboratories, Salt Lake City, UT, United States;3. ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States;1. Department of Pathology, University of Utah, Salt Lake City, UT, USA;2. ARUP Laboratories, Salt Lake City, UT, USA;3. ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA;1. Department of Endocrinology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan, China;2. Department of Hematology, West China Hospital of Sichuan University, West China School of Nursing, Sichuan University, Chengdu 610041, Sichuan, China;3. Hematology Research Laboratory, Department of Hematology, West China Hospital of Sichuan University, Chengdu 610041, Sichuan, China;1. Beaumont Eye Institute, 3535 West 13 Mile Road #555, Royal Oak, MI, USA;2. Consultants in Ophthalmic and Facial Plastic Surgery, 29201 Telegraph Road, Suite 324, Southfield, MI, USA
Abstract:BackgroundAs thyroid-stimulating immunoglobulins (TSI) are a sign of Graves' disease (GD), measuring TSI titers is becoming increasingly important for GD diagnosis. This study evaluated the diagnostic accuracy of a new fully automated TSI immunoassay (Immulite? TSI assay) in GD patients and compared it to the third generation thyroid-stimulating hormone receptor antibody (TRAb) electrochemiluminescence assay (Elecsys Anti-TSHR assay). Additionally, clinical characteristics associated with responsiveness to methimazole in patients with newly diagnosed GD were preliminarily explored.MethodsThis study involved 324 subjects, comprising patients with untreated GD (GD-UT), Graves’ ophthalmopathy (GO) patients, GD patients who had been treated for > 12 months (GD-T), autoimmune thyroiditis (AIT) patients, and healthy subjects (HS). The Immulite? TSI and Elecsys Anti-TSHR assay were performed on all samples. According to their responsiveness to methimazole, the GD-UT patients were divided into rapid and slow responder groups, and their clinical characteristics were compared.ResultsA receiver operating characteristic (ROC) curve analysis of GD-UT patients showed that the optimal TSI cut-off value was 0.57 IU/L. Logistic regression revealed that age and initial FT4 and TSI levels in the middle-dose methimazole group were related to a rapid response, while the initial FT4 level, but not TSI, in the high-dose group was also associated with a rapid response.ConclusionsThe clinical diagnostic performance of the Immulite? TSI assay for diagnosing GD was comparable to that of the Elecsys Anti-TSHR assay. The initial FT4 and TSI levels can be used as predictors of the responsiveness to methimazole in patients with newly diagnosed GD.
Keywords:Graves’ disease  Diagnostic efficacy  Methimazole  Responsiveness  Thyroid-stimulating immunoglobulin
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