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Thrombotic risk assessment and analytical performance of the chemiluminescent analyzer IDS-iSYS for the detection of anti-cardiolipin and anti-beta 2 glycoprotein I autoantibodies
Clinical Immunology ( IF 8.6 ) Pub Date : 2018-07-11 , DOI: 10.1016/j.clim.2018.07.006
Nafai Salma , Lemerle Julie , Bendaoud Boutahar , Le Nuz Sylvie , Bettacchioli Eleonore , Le Ny Fabien , Pasquier Elisabeth , Jousse-Joulin Sandrine , Couturaud Francis , Hillion Sophie , Renaudineau Yves

Patients with antiphospholipid antibodies (APLA) are predisposed to develop thrombosis, however the standardization of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein I (β2-GPI) Ab assays are challenging. Therefore we decided to test the performance of a new chemiluminescent assay (CLIA), and assayed aCL and aβ2-GPI IgG/M in serum from 120 healthy individuals, 108 patients with idiopathic venous thrombosis, 78 patients with antiphospholipid syndrome (APS), and 64 non-thrombotic APLA-carriers using CLIA IDS-iSYS. Very good (aCL/aβ2-GPI IgG) to moderate (aCL/aβ2-GPI IgM) agreement with a commercial and an in house ELISA assay were observed and, in particular, CLIA demonstrated the highest sensitivity in aβ2-GPI IgG detection. Finally, aCL/aβ2-GPI Ab capacity to predict the thrombotic risk was tested showing for CLIA a significant odds ratio (OR) when considering double positivity for aCL/aβ2-GPI IgG, aCL IgG at high levels, and aβ2-GPI IgG at high levels. In conclusion, CLIA improves aβ2-GPI IgG detection and thrombotic risk assessment.



中文翻译:

化学发光分析仪IDS-iSYS用于检测抗心磷脂和抗β2糖蛋白I自身抗体的血栓风险评估和分析性能

具有抗磷脂抗体(APLA)的患者易患血栓形成,但是抗心磷脂(aCL)和抗β2糖蛋白I(β2-GPI)Ab检测的标准化具有挑战性。因此,我们决定测试一种新的化学发光测定(CLIA)的性能,并测定了120例健康个体,108例特发性静脉血栓形成,78例抗磷脂综合征(APS)和使用CLIA IDS-iSYS的64种非血栓性APLA载体。观察到与商业和内部ELISA测定的非常好(aCL /aβ2-GPIIgG)到中度(aCL /aβ2-GPIIgG)一致性,尤其是CLIA在aβ2-GPIIgG检测中表现出最高的灵敏度。最后,当考虑对aCL /aβ2-GPIIgG,高水平的aCL IgG和高水平的aβ2-GPIIgG的双重阳性时,测试了aCL /aβ2-GPI的Ab预测血栓风险的能力,从而显示CLIA的显着优势比(OR)。 。总之,CLIA可改善aβ2-GPIIgG检测和血栓形成风险评估。

更新日期:2018-07-11
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