Diana Tanja, Wüster Christian, Olivo Paul D, Unterrainer Angelica, König Jochem, Kanitz Michael, Bossowski Artur, Decallonne Brigitte, Kahaly George J
Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.
Endocrine Laboratory Prof. Wüster, Mainz, Germany.
Eur Thyroid J. 2017 Sep;6(5):243-249. doi: 10.1159/000478522. Epub 2017 Aug 8.
The measurement of TSH receptor (TSHR) antibodies is warranted for diagnosis of Graves' disease (GD).
The performance, detection sensitivity, and specificity of 6 TSHR immunoassays were compared.
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.
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 ( < 0.002 vs. bioassay) and Kronus ELISA ( = 0.039) assays, and 1:27 in the Kryptor and Dynex ELISA ( < 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.
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.
促甲状腺激素受体（TSHR）抗体检测对于格雷夫斯病（GD）的诊断很有必要。
比较6种TSHR免疫测定方法的性能、检测灵敏度和特异性。
在自身免疫性甲状腺疾病患者中进行稀释研究，比较两种生物测定法和4种结合测定法（Kronus、Immulite、Kryptor、Dynex）。将两种生物测定法与使用刺激（M22）和阻断（K1-70）单克隆抗体（MAb）混合物的两种结合测定法进行比较。
对30例来自刺激（TSAb）阳性/阻断（TBAb）阴性的GD患者的样本进行连续稀释，并在所有测定中进行检测。在TSAb生物测定法中，样本稀释至1:2187仍呈阳性，在Immulite（<0.002 vs生物测定法）和Kronus ELISA（=0.039）测定法中稀释至1:81仍呈阳性，在Kryptor和Dynex ELISA测定法中稀释至1:27仍呈阳性（<0.001 vs生物测定法）。10例来自TBAb阳性/TSAb阴性的GD或桥本甲状腺炎患者的样本在所有结合测定中均呈阳性。没有一种结合测定法能区分TSAb和TBAb。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和100% M22（20 ng/mL）的混合物在Immulite（26.4、20.2、15.2、10.5、6.3、2.00 IU/L）和Kronus测定法（27.1、23.3、19.3、12.0、5.7、2.2 IU/L）中均呈阳性。这些MAb混合物在TBAb生物测定法中进行检测，分别显示出82%、61%、24%（阴性）、-26%（阴性）、-77%（阴性）和-95%（阴性）的抑制率。
样本稀释研究显示TSAb生物测定法具有更高的检测灵敏度，抗体混合物研究表明生物测定法相对于所有自动化和ELISA结合测定法具有独特的特异性。
