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Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism

Autoimmunity Highlights volume 1, pages95–100(2010)Cite this article

Abstract

Purpose

Specific autoantibodies acting as TSH receptor agonists (TRAb) are responsible for Graves’ disease (GD). In the last 30 years three generations of assay methods for the detection of TRAb have become available. The aim of this multicentre study was to evaluate the analytical sensitivity, precision and diagnostic accuracy of TRAb measurement using a new automated assay in comparison with a second-generation standard method.

Methods

Serum samples from patients with GD (n=82), autoimmune thyroiditis (AIT, n=57) or hyperthyroidism (HT, n=292), from 106 healthy subjects and from 57 patients with infectious diseases were analysed using a third-generation TRAb immunoassay (anti-TSHR, RAD 120; Radim, Italy) based on the human monoclonal TSH receptor antibody M22.

Results

Using a cut-off value of 1.25 mIU/l, established by ROC curve analysis, 80/82 GD patients (97.5%), 68/292 HT patients (23.2%), and 6/57 AIT patients (10.5%) were TRAb-positive with the M22-based automated assay. The percentages of TRAb positivity were lower in the same patients when the measurements were done with the second-generation method (95.1%, 18.9%, 7.0%, respectively).

Conclusion

The M22-based automated immunoassay shows high functional sensitivity (0.4 mIU/l) and high diagnostic specificity, is more sensitive than the standard second-generation method and is less time-consuming and labourintensive, and is therefore the up-to-date technology for TRAb detection in clinical practice.

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Author information

Affiliations

  1. Clinical Pathology Laboratory, Beata Vergine delle Grazie Hospital, Latisana, Italy

    Renato Tozzoli & Graziano Kodermaz

  2. Allergology and Immunology Unit, S. Maria degli Angeli Hospital, Pordenone, Italy

    Danilo Villalta

  3. Department of Internal Medicine, S. Martino Hospital, University of Genua, Genua, Italy

    Marcello Bagnasco & Giampaola Pesce

  4. Clinical Pathology Laboratory, S. Antonio Hospital, Tolmezzo, Italy

    Nicola Bizzaro

Authors
  1. Renato Tozzoli
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  2. Graziano Kodermaz
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  3. Danilo Villalta
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  4. Marcello Bagnasco
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  5. Giampaola Pesce
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  6. Nicola Bizzaro
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Corresponding author

Correspondence to Renato Tozzoli.

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Tozzoli, R., Kodermaz, G., Villalta, D. et al. Accuracy of receptor-based methods for detection of thyrotropin-receptor autoantibodies: a new automated third-generation immunoassay shows higher analytical and clinical sensitivity for the differential diagnosis of hyperthyroidism. Autoimmun Highlights 1, 95–100 (2010). https://doi.org/10.1007/s13317-010-0014-4

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Keywords

  • TSHR antibodies
  • Automated TRAb immunoassay
  • Graves’ disease
  • Hyperthyroidism
  • Sensitivity
  • Specificity

Autoimmunity Highlights

ISSN: 2038-3274

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