AI Article Synopsis
- A new automated electrochemiluminescence immunoassay has been developed to quickly measure TSH receptor autoantibodies (TRAb) in patients.
- This assay was tested in a multicenter international trial involving various thyroid conditions and showed high sensitivity and specificity, particularly for Graves' disease.
- The study concludes that this assay could become the standard for fast and accurate TRAb detection, distinguishing it effectively from other thyroid diseases.
Article Abstract
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.
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| http://dx.doi.org/10.1111/j.1365-2265.2008.03512.x | DOI Listing |
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