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Updated: Jun 27, 2026
Generation of a Mouse Spontaneous Autoimmune Thyroiditis Model
Published on: March 17, 2023
Technical evaluation of the first fully automated assay for the detection of TSH receptor autoantibodies
Derik Hermsen1, Martina Broecker-Preuss, Marco Casati
1Central Institute for Clinical Chemistry and Laboratory Medicine, University Hospital Duesseldorf, Germany. hermsen@med.uni-duesseldorf.de
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.
