三种促甲状腺素受体抗体检测方法在甲状腺相关性眼病中的敏感性
Sensitivity of three thyrotropin receptor antibody assays in thyroid-associated orbitopathy.
作者信息
Sarić-Matutinović Marija, Diana Tanja, Nedeljković-Beleslin Biljana, Ćirić Jasmina, Žarković Miloš, Perović-Blagojević Iva, Kahaly George J, Ignjatović Svetlana
机构信息
University of Belgrade, Faculty of Pharmacy, Belgrade.
Johannes Gutenberg University (JGU) Medical Center, Department of Medicine I, Molecular Thyroid Research Laboratory, Mainz, Germany.
出版信息
J Med Biochem. 2022 Apr 8;41(2):211-220. doi: 10.5937/jomb0-34718.
BACKGROUND
Thyrotropin receptor autoantibodies (TSH-RAb) 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) cellbased 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 (r=0.893, p<0.001), compared to the bioassay (r=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.
背景
促甲状腺素受体自身抗体（TSH-RAb）是甲状腺相关眼病（TAO）实验室评估中不可或缺的生物标志物。本研究评估了三种不同的TSH-R-Ab检测方法在TAO患者中的临床敏感性。
方法
连续纳入87例TAO患者，并采用三种检测方法对其血清样本进行平行分析。采用电化学发光免疫分析（ECLIA）竞争结合法和化学发光桥联免疫分析法检测总TSH-R-Ab和结合型TSH-R-Ab浓度，同时采用基于刺激型TSH-R-Ab（TSAb）的细胞生物分析法测定其功能活性。
结果
与两种结合法（ECLIA，p<0.001；桥联法，p=0.003）相比，TSAb生物分析法在TAO患者TSH-R-Ab阳性检测方面更敏感。ECLIA法和桥联法在灵敏度方面无差异（p=0.057）。所有活动期和/或中重度TAO患者的TSAb生物分析法检测均为阳性（分别为100%和100%），而活动期TAO患者桥联法和ECLIA结合法的阳性率分别为89.7%和82.1%，重度TAO患者分别为90.2%和86.3%。生物分析法、桥联法和ECLIA法对活动期TAO的阴性预测值分别为100%、75%和71%，对中重度TAO的阴性预测值分别为100%、86%和71%。生物分析法的优势在甲状腺功能正常（ET）的TAO患者中最为突出。非活动期TAO患者TSAb生物分析法、桥联法和ECLIA结合法的阳性率分别为89.6%、75%和64.6%；轻度TAO患者分别为86.1%、69.4%和52.8%；甲状腺功能正常的TAO患者分别为87.5%、62.5%和12.5%。与生物分析法（r=0.669，p<0.001）相比，桥联法与ECLIA结合法的相关性更好（r=0.893，p<0.001）。
结论
在不同活动度和严重程度的TAO患者中，TSAb生物分析法的临床性能优于ECLIA法和桥联结合法。
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