| Performance of a third generation TSH-receptor antibody (TRAb) in a UK clinic. | |
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MedLine Citation:
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PMID: 21521291 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background: UK national guidelines recommend the measurement of TSH receptor antibodies (TRAb) in certain clinical scenarios. A commercial third generation TRAb autoantibody M22-biotin ELISA assay was introduced in May 2008 in our centre. Objective: To evaluate the diagnostic performance of a TRAb assay in a retrospective and subsequently a prospective cohort in a UK centre. Design: A retrospective review of patients with thyroid disease followed by a prospective observational study in consecutive patients with newly found suppressed serum thyrotrophin (TSH). Patients and measurements: Medical records of 200 consecutive patients with thyroid disorders who had TRAb measured since the introduction of the assay. In a prospective study 44 patients with newly identified hyperthyroidism (TSH <0.02 mIU/L) had sera assayed for TRAb prior to their clinic appointment at which a final diagnosis was sought. Results: In the retrospective cohort, the manufacturer's cut-off point of TRAb ≥0.4 u/L resulted in a positive predictive value (PPV) of 95%, sensitivity 85%, specificity 94% and negative predictive value (NVP) 79%to diagnose Graves' disease using defined criteria. Receiver operating characteristic (ROC) analysis determined an optimal cut-off point of TRAb ≥3.5 u/L with a 100% specificity to exclude patients without Graves' disease at the cost though of a lower sensitivity (43%). In the prospective study, the sensitivity, PPV, specificity and NPV were all 96% using the ≥0.4 u/L cut-off. When combining hyperthyroid patients from both cohorts the assay sensitivity and specificity at ≥0.4 u/L cut-off were 95% and 92% respectively. A positive TRAb result increased the probability of Graves' disease for a particular patient by 25-35% and only 6 (2.5%) patients had a diagnosis of hyperthyroidism of uncertain aetiology after TRAb testing. Conclusions: The assay studied specifically identifies patients with Graves' disease. It is a reliable tool in the initial clinical assessment to determine the aetiology of hyperthyroidism and has the potential for cost-savings. |
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Authors:
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A Theodoraki; G Jones; J Parker; E Woolman; N Martin; S Perera; M Thomas; C Bunn; B Khoo; Pm Bouloux; Mpj Vanderpump |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-2-19 |
Journal Detail:
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Title: Clinical endocrinology Volume: - ISSN: 1365-2265 ISO Abbreviation: - Publication Date: 2011 Feb |
Date Detail:
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Created Date: 2011-4-27 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0346653 Medline TA: Clin Endocrinol (Oxf) Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 Blackwell Publishing Ltd. |
Affiliation:
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Department of Endocrinology Department of Clinical Immunology Department of Clinical Biochemistry, Royal Free Hampstead NHS Trust, London, United Kingdom. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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