SENSITIVITY OF THREE THYROTROPIN RECEPTOR ANTIBODY ASSAYS IN THYROID-ASSOCIATED ORBITOPATHY

Sensitivity of TSH-R-Ab assays in TAO

  • Marija Sarić Matutinović
  • Tania Diana Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany
  • Biljana Nedeljković Beleslin Clinic for Endocrinology, Diabetes and Metabolic Disorders, University Clinical Center of Serbia, Belgrade, Serbia, University of Belgrade, Medical Faculty, Belgrade, Serbia
  • Jasmina Ćirić Clinic for Endocrinology, Diabetes and Metabolic Disorders, University Clinical Center of Serbia, Belgrade, Serbia; University of Belgrade, Medical Faculty, Belgrade, Serbia
  • Miloš Žarković Clinic for Endocrinology, Diabetes and Metabolic Disorders, University Clinical Center of Serbia, Belgrade, Serbia, University of Belgrade, Medical Faculty, Belgrade, Serbia
  • Iva Perović Blagojević Service for laboratory diagnostics, Clinical Hospital Center “Dr Dragiša Mišović-Dedinje”, Belgrade, Serbia
  • George J. Kahaly Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany
  • Svetlana Ignjatović University of Belgrade, Faculty of Pharmacy, Belgrade, Serbia; Center for Medical Biochemistry, University Clinical Center of Serbia, Belgrade, Serbia
DOI: https://doi.org/10.5937/jomb0-34718
Keywords: thyroid-associated orbitopathy, thyrotropin receptor antibodies, bioassay, bridge binding assay, ECLIA binding assay

Abstract


Background: Thyrotropin receptor autoantibodies (TSH-R-Ab) are indispensable biomarkers in the laboratory assessment of thyroid-associated orbitopathy (TAO). Clinical sensitivity of three different assays for TSH-R-Ab determination was evaluated in patients with TAO.

Methods: 87 consecutive TAO patients were enrolled and their serum samples analyzed in parallel with three assays. An ECLIA competitive binding and a chemiluminescent bridge immunoassay were used to measure total and binding TSH-R-Ab concentration, while their functional activity was determined using a stimulatory TSH-R-Ab (TSAb) cell-based bioassay.

Results: Compared to the two binding assays (ECLIA p<0.001, bridge p=0.003), the TSAb bioassay was more sensitive pertaining to the positive detection of TSH-R-Ab in TAO patients. No difference (p=0.057) was noted between the ECLIA and bridge assays regarding sensitivity rate. All patients with active and/or moderate-to-severe TAO tested positive in the TSAb bioassay (100% and 100%, respectively), while the positivity rates for bridge and ECLIA binding assays were 89.7% and 82.1% for active TAO, and 90.2% and 86.3% for severe TAO, respectively. Negative predictive values of the bioassay, bridge, and ECLIA assays were 100%, 75%, and 71%, respectively for active TAO, and 100%, 86%, and 71%, respectively for moderate-to-severe TAO. The superiority of the bioassay was most prominent in euthyroid (ET) TAO. Positivity rates of the TSAb bioassay, bridge and ECLIA binding assays were 89.6%, 75%, and 64.6%, respectively for inactive TAO; 86.1%, 69.4%, and 52.8%, respectively for mild TAO; 87.5%, 62.5%, and 12.5%, respectively for euthyroid TAO. The bridge assay correlated better with the ECLIA binding assay (ρ=0.893, p<0.001), compared to the bioassay (ρ=0.669, p<0.001).

Conclusions: In patients with TAO of various activity and severity, the TSAb bioassay demonstrates a superior clinical performance compared to both ECLIA and bridge binding assays.

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Published
2021/12/06
Issue
Vol. 41 No. 2 (2022): Journal of Medical Biochemistry
Section
Original paper

Copyright (c) 2021 Marija Sarić Matutinović, Tania Diana, Biljana Nedeljković Beleslin, Jasmina Ćirić, Miloš Žarković, Iva Perović Blagojević, George J. Kahaly, Svetlana Ignjatović

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