Clinical performance of automated chemiluminescent methods for anticardiolipin and anti-beta 2-glycoprotein I antibodies detection in a large cohort of Chinese patients with antiphospholipid syndrome
Clinical performance of automated chemiluminescent methods for anticardiolipin and anti-beta 2-glycoprotein I antibodies detection in a large cohort of Chinese patients with antiphospholipid syndrome
复制标题
自动化学发光方法检测抗心磷脂和抗 β2-糖蛋白 I 抗体在大型中国抗磷脂综合征患者中的临床表现
DOI：
10.1111/ijlh.13156
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发表时间：
2020
影响因子：
3
通讯作者：
Shi Hui
中科院分区：
文献类型：
--
作者：
Wan Li-yan;Gu Jie-yu;Liu Ting-ting;Hu Qiong-yi;Jia Jin-chao;Teng Jia-lin;Sun Yue;Liu Hong-lei;Cheng Xiao-bing;Ye Jun-na;Su Yu-tong;Wu Xin-yao;Chi Hui-hui;Zhou Zhuo-chao;Wang Zhi-hong;Zhou Jin-feng;Norman Gary L.;Dai Jing;Yang Cheng-de;Shi Hui
目的评价自动化学发光法（CIA）和酶联免疫吸附法（ELISA）检测抗磷脂（aPL）抗体诊断抗磷脂综合征（APS）的临床性能和相关性。方法本研究招募了505名受试者，包括192名APS患者，193名非APS结缔组织疾病患者和120名健康供体。我们测量抗心磷脂（aCL）和抗β2-糖蛋白I（抗β2GPI）抗体IgG，IgM和伊加在所有样本使用CIA和ELISA。结果两种方法之间的总符合率范围从83.50%的抗β 2GPI IgG抗体的92.76%的抗β2GPI IgM抗体。抗β 2 GPI和aCL IgG检测显示最高的斯皮尔曼rho系数（抗β 2 GPI IgG = 0.742，aCL IgG = 0.715）。抗β2GPI IgG CIA诊断APS的敏感性最高，为80.21%，显著高于抗β2GPI IgG ELISA的敏感性（52.08%）。对于APS的诊断，抗β2GPI IgG CIA具有最佳区分能力，曲线下面积（AUC）为0.922，其次是aCL IgG CIA（AUC为0.905）。虽然CIA AUC略高，在所有情况下，差异不具有统计学意义。ConclusionCIA测量有一个很好的协议和相关性比较ELISA检测。然而，CIA抗β2GPI IgG对APS诊断的敏感性显著更高。两种检测方法显示出相当的预测能力，并支持CIA方法用于改善APS患者诊断和管理的价值。
IntroductionTo assess the clinical performance and correlations of automated chemiluminescence assay (CIA) and enzyme‐linked immunosorbent assay (ELISA) for detecting antiphospholipid (aPL) antibodies in the diagnosis of antiphospholipid syndrome (APS).MethodsThe study recruited 505 subjects, including 192 with APS, 193 with connective tissue diseases other than APS, and 120 healthy donors. We measured anticardiolipin (aCL) and anti‐β2‐glycoprotein I (anti‐β2GPI) antibodies IgG, IgM, and IgA in all the samples using both CIA and ELISA.ResultsTotal agreement between the two methods ranged from 83.50% for anti‐β2GPI IgG antibodies to 92.76% for anti‐β2GPI IgM antibodies in all the groups. Anti‐β2GPI and aCL IgG assays showed the highest Spearman's rho coefficients (anti‐β2GPI IgG = 0.742, aCL IgG = 0.715). Anti‐β2GPI IgG CIA showed the highest sensitivity for diagnosis of APS at 80.21%, which was significantly higher than the sensitivity of anti‐β2GPI IgG ELISA (52.08%). For diagnosis of APS, anti‐β2GPI IgG CIA had the best discrimination power with the area under the curves (AUC) of 0.922, followed by aCL IgG CIA (AUC of 0.905). While the CIA AUC was slightly higher in all cases, the difference was not statistically significant.ConclusionCIA measurements had a good agreement and correlation with comparative ELISA assays. The CIA anti‐β2GPI IgG however was significantly more sensitive for APS diagnosis. The two assay methodologies showed comparable predictive powers and support the value of the CIA method for improved diagnosis and management of patients with APS.