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Background: The measurement of TSH receptor (TSHR) antibodies is warranted for diagnosis of Graves’ disease (GD). Objective: The performance, detection sensitivity, and specificity of 6 TSHR immunoassays were compared. Methods: Two bioassays and 4 binding assays (Kronus, Immulite, Kryptor, Dynex) were compared in a dilution study performed in patients with autoimmune thyroid disease. Both bioassays were compared to 2 binding assays using stimulatory (M22) and blocking (K1–70) monoclonal antibody (MAb) mixtures. Results: Thirty samples from stimulatory (TSAb)-positive/blocking (TBAb)-negative patients with GD were diluted serially and measured in all assays. Samples were positive until dilution 1:2,187 in the TSAb bioassay, 1:81 in the Immulite (p < 0.002 vs. bioassay) and Kronus ELISA (p = 0.039) assays, and 1:27 in the Kryptor and Dynex ELISA (p < 0.001 vs. bioassay). Ten samples from TBAb-positive/TSAb-negative patients with GD or Hashimoto’s thyroiditis were positive in all binding assays. None of the binding assays differentiated between TSAb and TBAb. Mixtures of 100% K1–70 (200 ng/mL), 80% K1–70 + 20% M22, 60% K1–70 + 40% M22, 40% K1–70 + 60% M22, 20% K1–70 + 80% M22, and 100% M22 (20 ng/mL) tested positive in both Immulite (26.4, 20.2, 15.2, 10.5, 6.3, 2.00 IU/L) and Kronus assays (27.1, 23.3, 19.3, 12.0, 5.7, 2.2 IU/L). These MAb mixtures were tested in the TBAb bioassay and showed 82, 61, 24 (negative), –26 (negative), –77 (negative), and –95% (negative) inhibition, respectively. Conclusions: The sample dilution study showed higher detection sensitivity for the TSAb bioassay, and the antibody mixture study demonstrated exclusive specificity of the bioassays over all automated and ELISA binding assays.
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-blocking antibodies; TSAbs, TSH receptor-stimulating antibodies. Discussion In this case, the discovery of congenital hypothyroidism in a neonate led to the diagnosis of maternal hypothyroidism. No fetal goiter was observed during pregnancy even though
Department of Clinical Sciences, Lund University, Lund, Sweden
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Department of Clinical Sciences, Lund University, Lund, Sweden
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Department of Clinical Sciences, Lund University, Lund, Sweden
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positive for TSH receptor blocking antibodies, followed by hyperthyroidism positive for TSH receptor-stimulating antibodies, after an episode of SAT. This was similar to our patient who developed TSH receptor antibodies and hypothyroidism, which remained
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, which contains components such as protein-bound hormones. The replacement with albumin solution brings new binding sites for free thyroid hormones leading, to a decrease in fT3 and fT4 levels [ 13 ]. In the case of GD, a reduction in TSH receptor-stimulating
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module (Roche Diagnostics). Anti-TSH receptor-stimulating antibodies were measured by 2000/2000 Immulite Xpi immunoassay (Siemens Medical Solutions, negative threshold <0.55 U/L). Ultrasound All US examinations were performed in Hôpital Erasme by
