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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

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Abstract

Background

Both thyroid-stimulating immunoglobulins immunoassay (TSI IA) and thyrotrophin receptor antibody immunoassay (TRAb IA) are commonly used for the diagnosis of Graves’ disease (GD). The aim of the present study was to compare the clinical diagnostic performance of these two methods.

Methods

Sera were obtained from 1103 subjects presenting a variety of clinical conditions from three centers: 100 subjects with untreated GD, 200 with treated GD, 62 with autoimmune thyroid disease(AIT), 216 with other thyroid diseases (OTHER-T), 214 with non-thyroid autoimmune diseases (NTAD), 191 with other diseases (OD), and 120 healthy subjects (HS). Both TSI and TRAb IAs were performed for all 1013 serum samples. Bioassay was performed for 86 samples whose TSI results were inconsistent the TRAb assay results.

Results

Comparing untreated GD patients with the control groups (AIT, NTAD, OTHER-T, OD, and HS) resulted in an area under the curve (AUC) of 0.992 for the TSI IA and 0.989 for the TRAb IA with no statistically significant difference observed between these AUC values (P = 0.2733). The best TSI CDP (clinical decision point) value was 0.42 IU/L. The differences in sensitivity (100% vs. 95%, P = 0.7991) and specificity (97.1% vs. 97.6%, P = 0.9426) between the TSI and TRAb IA were not statistically significant. TSI IA had a higher agreement with the TSI bioassay than TRAb IA.

Conclusion

The clinical diagnostic performance of the TSI IA for diagnosing Graves’ disease was very similar to that of the TRAb IA. TSI IA can be used to diagnose GD in the Chinese.

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Abbreviations

TSHR:

Thyroid-stimulating hormone receptor

TRAb:

Thyrotrophin receptor antibody

TSI:

Thyroid-stimulating immunoglobulin

GD:

Graves’ disease

TSBAb:

Thyroid-stimulating blocking antibody

IA:

Immunoassay

BA:

Bioassay

M22:

Human TSHR-stimulating antibody

GD-UT:

Untreated Graves’ disease

GD-T:

Treated Graves’ disease

AIT:

Autoimmune thyroiditis

OTHER-T:

Other thyroid diseases

NTAD:

Non-thyroid autoimmune diseases

OD:

Other diseases

HS:

Healthy subjects

ROC:

Receiver operating characteristic

hTSHR:

Human thyroid-stimulating hormone receptor

TG-Ab:

Thyroglobulin antibody

TPO-Ab:

Thyroid peroxidase antibody

TSH:

Thyroid stimulating hormone

FT4:

Free thyroxine

FT3:

Free triiodothyronine

TT4:

Total thyroxine

TT3:

Total triiodothyrogen

CV:

Coefficient of variation

SE:

Sensitivity

SP:

Specificity

ICC:

Interclass correlation coefficient

CDP:

Clinical decision point

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Acknowledgements

The authors are grateful to Siemens (China) Co., Ltd, for providing technical support.

Author contributions

XC, XL, and LQ designed the study. CM, XC, and LQ analyzed the data. XL and XC were responsible for patient enrollment QJ, HZ, ZD, ZZ, YH, AS, and GY contributed materials and analyte detection. CM and XC contributed manuscript writing. All authors reviewed the manuscript.

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Authors and Affiliations

  1. Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China

    Xinqi Cheng, Chaochao Ma, Yingying Hu, Ailing Song, Guohua Yang & Ling Qiu

  2. Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China

    Xiaofeng Chai & Xiaolan Lian

  3. Nuclear Medicine Department, Tianjin Medical University General Hospital, Tianjin, 300052, China

    Qiang Jia

  4. Nuclear Medicine Department, The Second Hospital of Tianjin Medical University, Tianjin, 300211, China

    Honggang Zhao & Zuncheng Zhang

  5. Department of Clinical Laboratory, Tianjin Medical University General Hospital, Tianjin, 300052, China

    Zuoliang Dong

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  1. Xinqi Cheng
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Correspondence to Ling Qiu or Xiaolan Lian.

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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.

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Informed consent was obtained from all individual participants included in the study.

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These authors contributed equally: Xinqi Cheng, Xiaofeng Chai, Chaochao Ma, Qiang Jia, Honggang Zhao

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Cheng, X., Chai, X., Ma, C. et al. Clinical diagnostic performance of a fully automated TSI immunoassay vs. that of an automated anti‑TSHR immunoassay for Graves’ disease: a Chinese multicenter study. Endocrine 71, 139–148 (2021). https://doi.org/10.1007/s12020-020-02386-2

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