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Clinical value of the first automated TSH receptor autoantibody assay for the diagnosis of Graves’ disease (GD): an international multicentre trial

2008; Wiley; Volume: 71; Issue: 4 Linguagem: Inglês

10.1111/j.1365-2265.2008.03512.x

1365-2265

M. Schott, Derik Hermsen, Martina Broecker-Preuß, Marco Casati, Jordi Càmara, Anja Eckstein, Dieter Gassner, Ruth Golla, Claudia Graeber, Josef van Helden, Keiko Inomata, Jochen Jarausch, Jürgen Kratzsch, Naoko Miyazaki, Miguel Ángel Navarro Moreno, Tsukasa Murakami, Heinz Jürgen Roth, Werner Stock, Jaeduk Yoshimura Noh, Werner A. Scherbaum, Klaus Mann,

Ophthalmology and Eye Disorders

Summary Background Most recently, a new rapid and fully automated electrochemiluminescence immunoassay for the determination of TSH receptor autoantibodies (TRAb) based on the ability of TRAb to inhibit the binding of a human thyroid‐stimulating monoclonal antibody (M22) has been established. Objective To evaluate this assay system in clinical routine based on an international multicentre trial and to compare the results with other established TRAb assays. Patients and measurements Totally 508 Graves’ disease (GD), 142 autoimmune thyroiditis, 107 subacute thyroiditis, 109 nonautoimmune nodular goitre, 23 thyroid cancer patients and 446 normal controls were retrospectively evaluated. Results ROC plot analysis revealed an area under curve of 0·99 (95% CI: 0·99–1·0) indicating a high assay sensitivity and specificity. The highest sensitivity (99%) and specificity (99%) was seen at a cut‐off level of 1·75 IU/l. Here, the calculated positive predictive value was 95%, whereas the negative predictive value was 100%. Applying the ROC plot‐derived cut‐off of 1·75 IU/l we found a sensitivity for TRAb positivity within the group of newly diagnosed GD patients of 97% which is in accordance to the sum of different nonautomated porcine TSH receptor‐based assays with a sensitivity of 94% indicating an excellent analytical performance of the new assay format. Detailed comparison of the automated and the sum of manual assays revealed a near identical specificity. Conclusion Our results demonstrate that this new assay system has a high sensitivity for detecting GD and specificity for discriminating from other thyroid diseases. This assay may represent the future technology for rapid fully automated TRAb detection.