The aim of the study was to investigate the use of serial measurements of TSH-receptor autoantibodies (TRAb) with the newest available assay technology to predict the course of Graves’ Orbitopathy (GO) during the first 24 months from disease onset. Serial serum samples from patients with GO (103 mild/135 severe) were collected between 2007 and 2017 and retrospectively analyzed. The course of GO were classified into mild/severe 12 months after manifestation (severe: NOSPECS≥5; mild<5). TRAb were measured with automated binding immunoassays (IU/l): TRAb Elecsys (Cobas, Roche), TRAb bridge assay (IMMULITE, Siemens), and a cell-based bioassay (percent of specimen to reference ratio - SRR%) (Thyretain, Quidel). Variable cut off levels of measured TRAb were calculated at specificity of 90% from receiver operator curve (ROC) analysis for several timepoints during the course of GO. To select one: 5–8 months after first GO symptoms, which is the timepoint for usual referals for treatment mild course could be predicted at cut offs of 1.5 IU/l (Elecsys), 0.8 IU/l (Immulite) and 402% SRR (Thyretain) and the risc of severe course has to be anticipated if TRAb are above 11.6 IU/l (Elecsys), 6.5 IU/l (Thyretain), and 714% SRR (Thyretain). The Thyretain bioassay showed the highest diagnostic sensitivity (using the commercial cut off’s) over the entire follow up period. TRAb measurements during the 24-month follow up of GO provide added value to the GO clinical activity and severity scores and should be used especially in the event of an unclear decision-taking situation with regard to therapy.

中文翻译：

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通过自动结合免疫测定和功能生物测定，使用连续测量的 TSH 受体自身抗体预测 Graves 眼眶病的进程

该研究的目的是调查使用最新的可用检测技术连续测量 TSH 受体自身抗体 (TRAb) 来预测疾病发作后前 24 个月内格雷夫斯眼眶病 (GO) 的病程。在 2007 年至 2017 年期间收集了 GO 患者（103 名轻度/135 名重度）的系列血清样本并进行了回顾性分析。GO病程在表现后12个月分为轻度/重度（重度：NOSPECS≥5；轻度<5）。使用自动结合免疫测定 (IU/l) 测量 TRAb：TRAb Elecsys（Cobas，Roche）、TRAb 桥测定（IMMULITE，Siemens）和基于细胞的生物测定（样本与参考比率的百分比 - SRR%）（Thyretain，奎德尔）。在 GO 过程中的几个时间点，根据受试者工作曲线 (ROC) 分析，以 90% 的特异性计算了测量的 TRAb 的可变截止水平。选择一个：在首次出现 GO 症状后 5-8 个月，这是通常转诊治疗轻度病程的时间点，可以在 1.5 IU/l (Elecsys)、0.8 IU/l (Immulite) 和 402% SRR 的临界值处进行预测如果 TRAb 高于 11.6 IU/l (Elecsys)、6.5 IU/l (Thyretain) 和 714% SRR (Thyretain)，则必须预测 (Thyretain) 和严重病程的风险。在整个随访期间，Thyretain 生物测定显示出最高的诊断灵敏度（使用商业临界值）。