Performance of a third-generation TSH-receptor antibody in a UK clinic.
| Title: | Performance of a third-generation TSH-receptor antibody in a UK clinic. |
|---|---|
| Authors: | Theodoraki A; Departments of EndocrinologyClinical ImmunologyClinical Biochemistry, Royal Free Hampstead NHS Trust, London, UK.; Jones G; Parker J; Woolman E; Martin N; Perera S; Thomas M; Bunn C; Khoo B; Bouloux PM; Vanderpump MP |
| Source: | Clinical endocrinology [Clin Endocrinol (Oxf)] 2011 Jul; Vol. 75 (1), pp. 127-33. |
| Publication Type: | Evaluation Study; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Blackwell Publishing Country of Publication: England NLM ID: 0346653 Publication Model: Print Cited Medium: Internet ISSN: 1365-2265 (Electronic) Linking ISSN: 03000664 NLM ISO Abbreviation: Clin Endocrinol (Oxf) Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Oxford : Blackwell Publishing; Original Publication: Oxford, Blackwell Scientific Publications. |
| MeSH Terms: | Immunoglobulins, Thyroid-Stimulating* ; Sensitivity and Specificity*; Receptors, Thyrotropin/*immunology ; Thyroid Diseases/*diagnosis; Enzyme-Linked Immunosorbent Assay/standards ; Graves Disease/diagnosis ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal ; Child ; Female ; Humans ; Male ; Middle Aged ; United Kingdom ; Young Adult |
| Abstract: | 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 six (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.; (© 2011 Blackwell Publishing Ltd.) |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal); 0 (Immunoglobulins, Thyroid-Stimulating); 0 (Receptors, Thyrotropin) |
| Entry Date(s): | Date Created: 20110428 Date Completed: 20150209 Latest Revision: 20220316 |
| Update Code: | 20260130 |
| DOI: | 10.1111/j.1365-2265.2011.04022.x |
| PMID: | 21521291 |
| Database: | MEDLINE |
Evaluation Study; Journal Article