US-based, Prospective, Blinded Study of Thyrotropin Receptor Antibody in Autoimmune Thyroid Disease
Authors' conclusion
Binding TSH-R-Ab assays are less sensitive than TSI bioassays and are not specific for stimulating antibodies. Measuring the function of TSH-R-Ab in a bioassay can provide useful information to clinicians.
Study context
- Population
- Unselected, consecutive, well-documented patients with various thyroid diseases and healthy controls, US endocrinology clinic
- Participants
- 162 participants
- Comparison
- Cobas and Immulite binding TSH-R-Ab assays vs thyroid-stimulating immunoglobin (TSI) bioassay
- Outcome
- Sensitivity and specificity of 4 TSH-R-Ab assays
Methodological detailsprospective, blinded, single-centre
- Prospective
- Blinded
- Single-centre
Performance
As reported in the abstract
TSH-R-Ab positivity in GD (n=104), irrespective of disease duration
TSI vs Immulite: P < 0.0025 · TSI vs Cobas: P < 0.0009
- All 4 TSH-R-Ab assays negative in patients without autoimmune thyroid disease (AITD)
- 42 of 42
Further findings
Positivity in newly diagnosed Graves' disease (GD) (n=15)
- Positive in TSI bioassay
- all 15
- Positive in Cobas and Immulite binding assays
- 11 (73%)
GD with biochemical subclinical hyperthyroidism
- TSI-positive but Immulite- and Cobas-negative
- 9 patients
Thyroid-blocking immunoglobin (TBI)-positive GD
- TBI-positive and TSI-negative; Immulite and Cobas positive in both
- 2 patients
Additional AITD samples (30 TBI-positive, 10 TSI-positive) tested blindly in binding assays
- TSI-positive samples positive in both binding assays
- 6 of 10
- TBI-positive samples positive in Cobas
- 30
- TBI-positive samples positive in Immulite
- 28
Original publication
US-based, Prospective, Blinded Study of Thyrotropin Receptor Antibody in Autoimmune Thyroid Disease. J Clin Endocrinol Metab. Published 19 July 2024. doi:10.
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