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Updated: Aug 5, 2026

Trans-vivo Delayed Type Hypersensitivity Assay for Antigen Specific Regulation
Published on: May 2, 2013
Clinical diagnosis of Graves' or non-Graves' hyperthyroidism compared to TSH receptor antibody test
Lauren Bell1,2, Ann Louise Hunter3,2, Angelos Kyriacou2,4
1Faculty of BiologyMedicine and Health, University of Manchester, Manchester, UK.
Background:
TSH receptor antibody (TRAb) is considered the gold standard diagnostic test for the autoimmunity of Graves' disease (GD), which is commonly diagnosed clinically.
Aim:
To evaluate the true positive (sensitivity) and true negative (specificity) rates of clinical diagnosis of GD or non-GD hyperthyroidism compared to the TRAb test.
Setting:
University teaching hospital in North West England.
Participants:
Patients in the Endocrinology service who had a TRAb measurement between December 2009 and October 2015.
Methods:
Electronic patient records were studied retrospectively for a pre-TRAb clinical diagnosis of GD or non-GD hyperthyroidism. We examined descriptive statistics and binary classification tests; Fisher exact test was used to analyse contingency tables.
Results:
We identified 316 patients with a mean age of 45 (range, 17-89) years; 247 (78%) were women. Compared to the TRAb result, clinical diagnosis had a sensitivity of 88%, specificity 66%, positive predictive value 72%, negative predictive value 84%, false negative rate 12%, false positive rate 34%, positive likelihood ratio 2.6 and negative likelihood ratio 0.2 (P < 0.0001).
Conclusions:
Clinicians were liable to both over- and under-diagnose GD. The TRAb test can help reduce the number of incorrect or unknown diagnoses in the initial clinical assessment of patients presenting with hyperthyroidism.

