Villalta Danilo, D'Aurizio Federica, Da Re Mirella, Ricci Debora, Latrofa Francesco, Tozzoli Renato
Immunology and Allergy Unit, S. Maria degli Angeli Hospital, Pordenone, Italy.
Clinical Pathology Laboratory, University Hospital, Udine, Italy.
Auto Immun Highlights. 2018 Feb 12;9(1):3. doi: 10.1007/s13317-018-0102-4.
Thyrotropin receptor (TSHR) autoantibodies (TRAbs) are a hallmark of Graves' disease (GD). The aim of this study was to evaluate the diagnostic accuracy of a new third generation automatic fluorescence enzyme immunoassay for TRAb measurement in GD, in comparison with two current IMAs.
Sera of 439 subjects (57 patients with untreated GD, 34 with treated GD, 15 with GD and Graves' orbitopathy, 52 with multinodular non-toxic goiter, 86 with Hashimoto's thyroiditis, 20 with toxic adenoma or toxic multinodular goiter, 55 with non-thyroid autoimmune diseases and 120 normal controls) were tested for TRAbs with the ELiA anti-TSH-R assay (ThermoFischer Scientific, Uppsala, Sweden), the TRAK RIA, Brahms (Thermo Scientific, Hennigsdorf, Germany) and the Immulite TSI assay (Siemens Healthcare, Llanberis, UK).
Sensitivity and specificity of the ELiA™ anti-TSH-R assay, TRAK™ RIA and Immulite™ TSI assay were 94.7% and 99.6, 100 and 98.2%, 100 and 98.2%, respectively. Spearman's coefficient and Passing-Bablok regression showed a satisfactory correlation between EliA™ and TRAK™ [rho: 0.925; 95% CI: 0.883-0-953. Intercept: - 0.875 (95% CI: - 2.411 to 0.194); slope: 1.086 (95% CI: 0.941 to 1.248)], and between ELiA and TSI [rho: 0.947; 95% CI: 0.912 0.969. intercept: 1.085 (95% CI: 0.665 to 2.116); slope 1.315 (95% CI:1.116 to 1.700)].
The diagnostic performance of ELiA-TSH-R assay is comparable to that of some current TRAb assays. It may be adopted into clinical practice for the differential diagnosis of hyperthyroidism, to screen for transient hyperthyroidism, and to monitor disease activity and treatment effects.
促甲状腺激素受体（TSHR）自身抗体（TRAbs）是格雷夫斯病（GD）的一个标志。本研究的目的是评估一种新型第三代自动荧光酶免疫分析法在检测GD患者TRAbs方面的诊断准确性，并与两种当前的免疫分析方法进行比较。
对439名受试者的血清进行检测（57例未经治疗的GD患者、34例接受治疗的GD患者、15例患有GD和格雷夫斯眼病的患者、52例多结节性非毒性甲状腺肿患者、86例桥本甲状腺炎患者、20例毒性腺瘤或毒性多结节性甲状腺肿患者、55例非甲状腺自身免疫性疾病患者和120名正常对照），使用ELiA抗TSH-R检测法（赛默飞世尔科技公司，瑞典乌普萨拉）、TRAK放射免疫分析法（德国耶拿分析仪器股份公司，德国亨尼希斯多夫）和Immulite促甲状腺素受体抗体检测法（西门子医疗公司，英国兰贝里斯）检测TRAbs。
ELiA™抗TSH-R检测法、TRAK™放射免疫分析法和Immulite™促甲状腺素受体抗体检测法的灵敏度和特异性分别为94.7%和99.6%、100%和98.2%、100%和98.2%。Spearman系数和Passing-Bablok回归显示ELiA™和TRAK™之间具有良好的相关性[rho：0.925；95%可信区间：0.883 - 0.953。截距：-0.875（95%可信区间：-2.411至0.194）；斜率：1.086（95%可信区间：0.941至1.248）]，以及ELiA和促甲状腺素受体抗体之间具有良好的相关性[rho：0.947；95%可信区间：0.912 - 0.969。截距：1.085（95%可信区间：0.665至2.116）；斜率1.315（95%可信区间：1.116至1.700）]。
ELiA-TSH-R检测法的诊断性能与一些当前的TRAbs检测法相当。它可用于临床实践中甲状腺功能亢进症的鉴别诊断、筛查短暂性甲状腺功能亢进症以及监测疾病活动和治疗效果。
