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Observational Study
. 2019 Apr 25;19(1):38.
doi: 10.1186/s12902-019-0363-6.

Comparison of Five TSH-Receptor Antibody Assays in Graves' disease: results from an observational pilot study

Tristan Struja  1 , Rebecca Jutzi  2 , Noemi Imahorn  2 , Marina Kaeslin  2 , Fabienne Boesiger  2 , Alexander Kutz  2 , Esther Mundwiler  3 , Andreas Huber  3 , Marius Kraenzlin  4 , Beat Mueller  2   5 , Christian Meier  5   4 , Luca Bernasconi  3 , Philipp Schuetz  2   5
Affiliations
Observational Study

Comparison of Five TSH-Receptor Antibody Assays in Graves' disease: results from an observational pilot study

Tristan Struja et al. BMC Endocr Disord. .

Abstract

Background: Early diagnosis and relapse prediction in Graves' disease influences treatment. We assessed the abilities of four TSH-receptor antibody tests [TRAb] and one cyclic adenosine monophosphate bioassay to predict relapse of Graves' disease.

Methods: Observational study investigating patients presenting with Graves' disease at a Swiss hospital endocrine referral center or an endocrine outpatient clinic. Main outcomes were diagnosis and relapse of Graves' disease after stop of anti-thyroid drugs. We used Cox regression to study associations of TRAb levels with relapse risk and calculated c-statistics [AUC] to assess discrimination. Blood draws took place as close as possible to treatment initiation.

Results: AUCs ranged from 0.90 (TSAb Biossay by RSR) to 0.97 (IMMULITE TSI by Siemens). Highest sensitivity (94.0%) was observed for IMMULITE TSI and RSR TRAb Fast, while the greatest specificity (97.9%) was found with the EliA anti-TSH-R (by Thermo Fisher). In Cox regression analysis comparing the highest versus the lower quartiles, the highest hazard ratio [HR] for relapse was found for BRAHMS TRAK (by Thermo Fisher) (2.98, 95% CI 1.13-7.84), IMMULITE TSI (2.40, 95% CI 0.91-6.35), EliA anti-TSH-R (2.05, 95% CI 0.82-5.10), RSR Fast TRAb (1.80, 95% CI 0.73-4.43), followed by RSR STIMULATION (1.18, 95% CI 0.46-2.99). Discrimination analyses showed respective AUCs of 0.68, 0.65, 0.64, 0.64, and 0.59.

Conclusion: The assays tested had good diagnostic power and relapse risk prediction with few differences among the new assays. Due to the small sample size and retrospective design with possible selection bias, our data need prospective validation.

Keywords: Bioassay; Graves’ disease; TRAb; Thyroid.

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Conflict of interest statement

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the local ethics committee (Ethikkommission Nordwest- und Zentralschweiz (EKNZ) Project No. 2015/227). Need for informed consent was waived by the local ethics committee due retrospective nature of analysis with no impact on health outcome.

Consent for publication

Not applicable.

Competing interests

BM and PS received research support by Thermo Fisher Scientific, Roche Diagnostics, Abbott and Siemens unrelated to this study. All authors confirm that they do not have a conflict of interest associated with this manuscript.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Distribution of TRAb levels in GD patients vs. diseased controls y-axis is on a logarithmic scale
Fig. 2
Fig. 2
Distribution of TRAb levels by diagnosis y-axes are on a logarithmic scale. 1, Graves’ disease. 2, Hashimoto’s thyroiditis. 3, Thyroiditis. 4, Toxic nodular goiter. 5, Other (i.e. amiodarone induced hyperthyroidism, euthyroid sick syndrome, postpartum thyroiditis,silent thyroiditis, euthyroid goiter, follicular and papillary carcinoma, functional TSH suppression after i.v. contrast agent). Panel a TRAb from Brahms. Panel b TRAb from Siemens. Panel c TRAb from Thermo Fisher Scientific. Panel d TRAb from RSR Limited. Panel e TSAb from RSR Limited
Fig. 3
Fig. 3
Distribution of TRAb levels at diagnosis according to relapse status. Median and IQR values according to the figure are presented in the first two columns of Table 1
Fig. 4
Fig. 4
Kaplan-Meier-Survival graphs of GREAT score with new TRAb assay instead of routine assay
See this image and copyright information in PMC

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