AI Article Synopsis
- Graves' disease (GD) is linked to autoantibodies that target the TSH receptor, and this study aimed to assess a new automated immunoassay (Elecsys Anti-TSHR) for detecting these antibodies.
- The test showed acceptable levels of precision with a functional sensitivity of 0.73 IU/L and strong correlation with existing TRAb immunoassays, indicating its effectiveness.
- The new automated assay demonstrated high sensitivity (97%) and specificity (99%) for diagnosing GD, marking a significant improvement in thyroid testing practices.
Article Abstract
Background: Graves' disease (GD) is mediated by autoantibodies which bind to the TSH receptor (TRAb). The aim of the present study was to evaluate the technical performance of the first fully automated immunoassay for TRAb detection.
Methods: The Elecsys Anti-TSHR immunoassay utilizes a porcine TSH receptor (TSHR) and the human thyroid stimulating monoclonal TSHR autoantibody M22.
Results: Intraassay and total imprecision CV were determined between 1.4%-14.9%, and 2.4%-28.8%, respectively. Using the 20% CV criteria the functional sensitivity was found at 0.73 IU/L. The median CV at the cut-off (1.75 IU/L) was found to be 11%. Comparison studies with five TRAb immunoassays yielded slopes and intercepts between 1.02-1.48, and -0.74-0.56, respectively. Correlation coefficients were determined between 0.895 and 0.978. ROC plot analysis of patients with GD, patients with other thyroid disorders and healthy controls revealed an AUC of 0.99 resulting in a sensitivity of 97% and a specificity of 99% at a TRAb level of 1.75 IU/L.
Conclusion: The evaluation of the TRAb immunoassay generated homogeneous performance data and demonstrated a high degree of comparability to established TRAb assays. The automated TRAb assay represents a major improvement of thyroid testing in clinical practice.
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| http://dx.doi.org/10.1016/j.cca.2008.11.025 | DOI Listing |
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- Recent guidelines from experienced endocrinologists emphasize the importance of TRAbs in GD management to improve effectiveness and decision-making for healthcare providers, particularly in South Asia.
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