Clinical diagnostic performance of a fully automated TSI immunoassay vs. that of an automated anti‑TSHR immunoassay for Graves’ disease: a Chinese multicenter study

Cheng, Xinqi; Chai, Xiangping; Ma, Chaochao; Jia, Qiang; Zhao, Heng; Zhao, Dong; Zhang, Zuncheng; Hu, Yingying; Song, Ailing; Yang, Guohua; Qiu, Ling; Lian, Xiaolan

doi:10.1007/s12020-020-02386-2

Cited by 8 publications

(20 citation statements)

References 24 publications

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“…In this way, TSI showed high diagnostic Se and Sp for GD diagnosis, of 98.9% and 100%, respectively. These data agree with previous data that show high TSI Se and Sp for GD diagnosis [1,6,11,24].…”

Section: Discussionsupporting

confidence: 93%

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A higher cut-off for Thyroid-stimulating immunoglobulin (TSI) could better predict relapse in Graves’ disease?

Fontes¹,

Negri²,

Marui³

et al. 2021

JCLR

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Background: TSH receptor (TSHr)-stimulating immunoglobulins (Igs) can be used as diagnostic markers of Graves’ disease (GD). Thyroid-stimulating immunoglobulin (TSI) assays exclusively detect these specific Igs. Materials and Methods: This was a prospective longitudinal study in which hyperthyroid patients with GD and toxic nodular goitres were evaluated at diagnosis. GD patients were also evaluated at antithyroid drug (ATD) withdrawal. An automated chemiluminescent assay measured TSI. According to the manufacturer TSI less than 0.55 IU/L was a non-reactive result. The authors evaluated the Se and Sp of the cutoff point provided by the TSI assay manufacturer, and tested other cutting points through a ROC curve, to assess relapse risk of Graves’ disease. Results: At diagnosis, were evaluated 92 (85.2%) GD patients aged 41.2 ± 2.0 years, and 16 patients (14.8%) with toxic multinodular goiter (TMNG) or toxic adenoma (TA), aged 60.8 ± 4.8 years. They were re-evaluated after 18 ± 4 months with methimazole (MMI) treatment. The follow-up after treatment suspension was of 20 ± 6 months. At diagnosis, the TSI (Se) and (Sp) were 98.9% and 100%, respectively. At ATD withdrawal, despite a high Se (95.5%), Sp was low (59.6%). By adjusting the cut-off to 1.11 (TSI <1.11 IU/L non-reactive), TSI presented the best Sp (89.4%) with a small decrease in Se (93.3%) in predicting GD relapse. Conclusions: TSI had high Se and Sp in GD differential diagnosis with nodular goiters. In the assessment for GD relapse, by raising the cutting point to 1.11 IU/L, a better Sp was obtained at the expense of a small drop in Se. A larger sample is needed to support a higher TSI cut-off point in the clinical routine to assess GD relapse after ATD.

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Section: Discussionsupporting

confidence: 93%

“…After ATD withdrawal GD patients had a follow-up 20 ± 6 months (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30). Laboratory data before treatment are in Table 1.…”

Section: Resultsmentioning

confidence: 99%

A higher cut-off for Thyroid-stimulating immunoglobulin (TSI) could better predict relapse in Graves’ disease?

Fontes¹,

Negri²,

Marui³

et al. 2021

JCLR

View full text Add to dashboard Cite

show abstract

“…The accurate diagnostic efficacy of TSI in patients with GD was also reported in previous literature. 2 , 8 – 10 , 23 , 24 …”

Section: Discussionmentioning

confidence: 99%

“…It was documented that the clinical diagnostic performance of thyroid-stimulating immunoglobulin (TSI) showed high and similar clinical effectiveness to that of TBII for diagnosing GD. 9 , 10 …”

Section: Introductionmentioning

confidence: 99%

The prognostic value of thyroid-stimulating immunoglobulin in the management of Graves’ disease

Zhou

et al. 2021

Therapeutic Advances in Endocrinology

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Background: The bioassay of thyroid-stimulating immunoglobulin was reported to have a similar performance to the commonly used thyroid-stimulating hormone binding inhibition assay, also known as thyroid receptor antibody assay. The normal reference range of thyroid receptor antibody levels indicates the withdrawal of anti-thyroid drugs in the recent clinical guidelines. Methods: A prospective, longitudinal observational study was conducted to evaluate the prognostic value of thyroid-stimulating immunoglobulin in patients with Graves’ disease. Results: A total of 77 patients with Graves’ disease treated with anti-thyroid drugs were in a continuous follow-up until 1 year after anti-thyroid drugs discontinuation. Commercial kits of thyroid-stimulating immunoglobulin and M22-thyroid-stimulating hormone binding inhibition assay were used and compared. Thyroid-stimulating immunoglobulin was all negative in healthy controls, Hashimoto thyroiditis, and subacute thyroiditis. Thyroid-stimulating immunoglobulin value was highest in untreated patients with Graves’ disease ( p < 0.001). Under anti-thyroid drugs treatment, thyroid-stimulating immunoglobulin value decreased gradually. A total of 21 patients had positive thyroid-stimulating immunoglobulin at the end of treatment. According to clinical fate of patients with Graves’ disease after withdrawal of anti-thyroid drugs, thyroid-stimulating immunoglobulin value and positivity in patients with relapse were significantly higher than that reported in patients with remission ( p = 0.001, p < 0.001). After adjustment for age, gender, initial thyroid receptor antibody, initial thyroid-stimulating immunoglobulin, and thyroid receptor antibody at the end of treatment, the odds ratio of positive thyroid-stimulating immunoglobulin for the risk of relapse was 33.271 (95% confidence interval: 4.741–233.458, p < 0.001) and odds ratio of quantitative thyroid-stimulating immunoglobulin was 1.009 (95% confidence interval: 1.002–1.015, p < 0.001). Conclusion: Thyroid-stimulating immunoglobulin is a good predictor of relapse in patients with Graves’ disease treated with anti-thyroid drugs. It might be safer to discontinue anti-thyroid drugs when thyroid-stimulating immunoglobulin and thyroid receptor antibody were both negative.

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“…21 also reported a significantly higher clinical decision point of 2.68 IU/L than 1.75 IU/L for Anti-TSHR assay based on Chinese populations.According to the reference interval of the two methods, 234 samples of 559 patients with suspected thyroid disease showed positive results in the two tests, which had good consistency. The main problem of TRAbs detection is the possibility of false-positive results in cases with chronic thyroiditis and hypothyroidism.…”

mentioning

confidence: 97%

Evaluation of analytic and clinical performance of two immunoassays for detecting thyroid‐stimulating receptor antibody in the diagnosis of Graves’ disease

Cen

et al. 2021

Clinical Laboratory Analysis

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Clinical diagnostic performance of a fully automated TSI immunoassay vs. that of an automated anti‑TSHR immunoassay for Graves’ disease: a Chinese multicenter study

Cited by 8 publications

References 24 publications

A higher cut-off for Thyroid-stimulating immunoglobulin (TSI) could better predict relapse in Graves’ disease?

A higher cut-off for Thyroid-stimulating immunoglobulin (TSI) could better predict relapse in Graves’ disease?

The prognostic value of thyroid-stimulating immunoglobulin in the management of Graves’ disease

Evaluation of analytic and clinical performance of two immunoassays for detecting thyroid‐stimulating receptor antibody in the diagnosis of Graves’ disease

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