| Detecting TSH-receptor antibodies with the recombinant TBII assay: technical and clinical evaluation. | |
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MedLine Citation:
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PMID: 11069209 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We evaluated the technical robustness of the new commercial TBII assay using human recombinant TSH-R, and describe its use for the clinician in the routine laboratory. The human recombinant TSH-R assay (DYNOtest TRAK human) was compared to a conventional TBII assay (TSH-REZAK). Specificity was adjusted at 99.1% for both assays by ROC plot analysis including 113 healthy individuals. Sensitivity in 115 patients with active Graves' Disease (GD) was 98.2% for the DYNOtest TRAK human compared to 68.4% for the TSH-REZAK (p<0.0001). Comparison of the ROC-calculated cut off confirmed the recommended cut-off for the DYNOtest TRAK human, since 11% inhibition of tracer equals 1 IU/L, which is recommended as the grey zone. At the recommended cut-off (2 IU/L, 22% inhibition), the sensitivity is still 93.9% with 100% specificity. The ROC plot-derived cut-off of the TSH-REZAK (4.4%, 2 to 10 U/L) is below the grey zone of 10-15 U/L. At the recommended cut off of 15 U/L, the sensitivity is 43.0% with a specificity of 100%. Both assays showed a good correlation (r = 0.82, p < 0.0001); however, assay comparison revealed a constant bias in favour of the DYNOtest TRAK human. Applying the ROC plot-derived cut-off of 11 % inhibition (1 IU/L) for the DYNOtest TRAK human, we found 15 of 50 patients with autoimmune thyroiditis (AIT) and 6 of 23 patients with goitre (all < 1.5 IU/L). These patients would have been missed using the recommended 2 IU/L. The difference in sensitivity between the DYNOtest TRAK human and the TSH-REZAK was highly significant in the GD group, but not in other groups, indicating that the DYNOtest TRAK human has a higher sensitivity for GD without compromising specificity. In summary, the proposed high sensitivity of the new TBII assay using human recombinant TSH-R could be confirmed with the commercial product. This method offers a clear advantage over conventional TBII assays to confirm or exclude the diagnosis of GD. The recommended cut-off is very stringent, and until we have more information on the clinical relevance of low-level TBII between 1 and 1.5 IU/L, those patients should be monitored for the development of autoimmune thyroid disease. |
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Authors:
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M Schott; J Feldkamp; C Bathan; R Fritzen; W A Scherbaum; J Seissler |
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Publication Detail:
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Type: Clinical Trial; Evaluation Studies; Journal Article |
Journal Detail:
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Title: Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et métabolisme Volume: 32 ISSN: 0018-5043 ISO Abbreviation: Horm. Metab. Res. Publication Date: 2000 Oct |
Date Detail:
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Created Date: 2001-03-06 Completed Date: 2001-05-31 Revised Date: 2009-02-19 |
Medline Journal Info:
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Nlm Unique ID: 0177722 Medline TA: Horm Metab Res Country: GERMANY |
Other Details:
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Languages: eng Pagination: 429-35 Citation Subset: IM |
Affiliation:
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Department of Endocrinology, Heinrich-Heine-University, Düsseldorf, Germany. schottmt@uni-duesseldorf.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Autoantibodies
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analysis* Binding Sites / immunology Follow-Up Studies Graves Disease / diagnosis*, radiotherapy, surgery Humans Iodine Radioisotopes / therapeutic use Receptors, Thyrotropin / immunology* Recombinant Proteins / diagnostic use Reference Values Reproducibility of Results Thyroiditis, Autoimmune / diagnosis*, radiotherapy, surgery |
| Chemical | |
Reg. No./Substance:
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0/Autoantibodies; 0/Iodine Radioisotopes; 0/Receptors, Thyrotropin; 0/Recombinant Proteins |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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