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首页> 外文期刊>Medicine. >Evaluation of the Clinical Performance of a Novel Chemiluminescent Immunoassay for Detection of Anticardiolipin and Anti-Beta2-Glycoprotein 1 Antibodies in the Diagnosis of Antiphospholipid Syndrome
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Evaluation of the Clinical Performance of a Novel Chemiluminescent Immunoassay for Detection of Anticardiolipin and Anti-Beta2-Glycoprotein 1 Antibodies in the Diagnosis of Antiphospholipid Syndrome

机译：评价新型化学发光免疫测定的临床表现，用于检测抗磷脂和抗β2-糖蛋白1抗体的抗磷脂综合征诊断中的1抗体

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摘要

Detection of antiphospholipid antibodies represents the first-line approach for diagnosis of antiphospholipid syndrome (APS). In this study, we evaluated the clinical performance of a novel chemiluminescence assay (CIA) in detection of IgG/IgM/IgA anti-cardiolipin (aCL) and IgG/IgM/IgA anti-2 glycoprotein 1 (a2GP1) antibodies and to compare it with commercial enzyme-linked immunosorbent assay (ELISA) kits from the same manufacturer.A total of 227 sera were tested in this study, including 84 samples from patients with APS, 104 samples from patients with non-APS diseases as disease controls, and 39 healthy controls. Serum IgG/IgM/IgA aCL and IgG/IgM/IgA a2GP1 were determined by both ELISA (QUANTA Lite ELISA) and CIA (QUANTA Flash (R) assays).Significant quantitative correlations were identified between ELISA and CIA in IgG/IgM/IgA aCL and IgG/IgM/IgA a2GP1 autoantibodies detection (P<0.001), with the rho value ranging from 0.51 to 0.87. In addition, ELISA and CIA demonstrated good qualitative agreements in IgG/IgM/IgA aCL and IgM/IgA a2GP1 autoantibodies determination with kappa coefficient ranged from 0.52 to 0.77. In contrast, ELISA and CIA showed a moderate qualitative agreement in IgG a2GP1 detection with a kappa value of 0.2. Notably, significantly higher IgG a2GP1 positive sera were detected by CIA, compared to those detected by ELISA in both primary APS (52.9% vs. 8.8%) and APS associated to other diseases sera (70.0% vs. 8.0%). For diagnosis of APS, IgG a2GP1 detection by CIA (IgG a2GP1 CIA) demonstrated the highest sensitivity (63.1%), followed by IgG aCL CIA (48.8%). More importantly, IgG a2GP1 CIA demonstrated the highest ability to predict the thrombotic events in patients with APS, with an OR of 3 (95% CI: 1.1-7.9).Our data suggest that this novel CIA assay had good performance in detecting aCL and a2GP1 antibodies, especially in the detection of IgG a2GP1 antibodies. Our findings could shed insight on the application of CIA in the laboratory diagnosis of APS in China.
机译：检测抗磷脂抗体代表抗磷脂综合征（APS）诊断的一线方法。在本研究中，我们评估了一种新的化学发光测定（CIA）在检测IgG / IgM / IgA抗癌素（ACL）和IgG / IgM / IgA抗2糖蛋白1（A2GP1）抗体中的临床表现并进行比较与来自同一制造商的商业酶联免疫吸附测定（ELISA）试剂盒。在本研究中测试了227株血清，其中来自APS患者的84个样本，来自非APS疾病的患者为疾病控制，39例健康的控制。血清IgG / IgM / IgA AC1和IgG / IgM / IgA A2GP1由ELISA（QuantaLite ELISA）和CIA（量子闪光（R）测定）测定。IgG / IgM / IgA中的ELISA和CIA之间鉴定了显着的定量相关性ACL和IgG / IgM / IgA A2GP1自身抗体检测（P <0.001），RHO值范围为0.51至0.87。此外，ELISA和CIA在IgG / IgM / IgA ACL和IgM / IgA A2GP1的良好定性协议中展示了Kappa系数的IgM / IgA A2GP1自身抗体测定范围为0.52至0.77。相比之下，ELISA和CIA在IGG A2GP1检测中显示了适度的定性协议，Kappa值为0.2。值得注意的是，CIA相比，CIA检测到显着高于IgG A2GP1正血清，而ELISA在初级AP（52.9％与8.8％）和与其他疾病血清相关的AP（70.0％与8.0％）中检测到的AP。对于APS的诊断，CIA（IgG A2GP1 CIA）的IgG A2GP1检测证明了最高的灵敏度（63.1％），其次是IgG ACL CIA（48.8％）。更重要的是，IgG A2GP1 CIA证明了预测APS患者血栓形成事件的最高能力，其中A或3个（95％CI：1.1-7.9）。我们的数据表明，这种新型CIA测定在检测ACL方面具有良好的性能。 A2GP1抗体，特别是在检测IgG A2GP1抗体。我们的研究结果可以阐述CIA在中国APS实验室诊断中的应用。

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  • 来源
    《Medicine.》 |2015年第46期|共7页
  • 作者

    Zhang Shulan; Wu Ziyan; Li Ping; Bai Yina; Zhang Fengchun; Li Yongzhe;

  • 作者单位

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

    Chinese Acad Med Sci Dept Rheumatol &

    Clin Immunol Peking Union Med Coll Hosp 1 Shuai Fu Yuan;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 医药、卫生;
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