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.
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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新型化学发光免疫分析检测抗心磷脂和抗 Beta2-糖蛋白 1 抗体在抗磷脂综合征诊断中的临床性能评估
DOI：
10.1097/md.0000000000002059
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发表时间：
2015-11
期刊：
影响因子：
1.6
通讯作者：
Li Y
中科院分区：
文献类型：
--
作者：
Zhang S;Wu Z;Li P;Bai Y;Zhang F;Li Y
摘要抗磷脂抗体的检测是诊断抗磷脂综合征(APS)的首选方法。在这项研究中，我们评价了一种新的化学发光法(CIA)在检测Ig G/Ig M/Ig A抗心磷脂(ACL)和Ig G/Ig M/Ig A抗-BGR；2糖蛋白1(a&BGR；2GP1)抗体方面的临床表现，并与同厂家的商品化的酶联免疫吸附试验(EL ISA)试剂盒进行了比较。血清Ig G/Ig M/Ig A aCL和Ig G/Ig M/Ig A a&bgr；2GP1分别采用双抗体夹心法(Quanta Lite™EL ISA)和免疫荧光试验(CIA)进行检测，两者之间存在显著的定量相关性(P <； 0.001)，Rho值在0.5 1~0.87之间。此外，ELISA法和CIA法在检测IgM/IgA ACL和IgM/IgAα&BGR；2GP1自身抗体方面具有较好的定性一致性，kappa系数在0.52~0.77之间。相反，ELISA和CIA在检测IgGa和BGR；2GP1方面表现出中等程度的定性一致性，kappa值为0.2。值得注意的是，CIA检测到的IgGa和GGR；2GP1阳性血清显著高于ELISA法(52.9%对8.8%)和与其他疾病相关的APS(70.0%对8.0%)。对APS的诊断，以CIA检测IgGa和BGR；2GP1的敏感性最高(63.1%)，其次是IgGACIA(48.8%)。更重要的是，IgGa和bgr；2GP1 CIA对APS患者血栓事件的预测能力最高，OR为3(95%CI：1.1~7.9)。我们的数据表明，这种新的CIA方法在检测ACL和a&bgr；2GP1抗体方面具有良好的性能，尤其是在检测IgGa和bgr；2GP1抗体方面。我们的研究结果为CIA在中国APS的实验室诊断中的应用提供了新的思路。
AbstractDetection 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-&bgr;2 glycoprotein 1 (a&bgr;2GP1) 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 a&bgr;2GP1 were determined by both ELISA (QUANTA Lite™ ELISA) and CIA (QUANTA Flash®assays).Significant quantitative correlations were identified between ELISA and CIA in IgG/IgM/IgA aCL and IgG/IgM/IgA a&bgr;2GP1 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 a&bgr;2GP1 autoantibodies determination with kappa coefficient ranged from 0.52 to 0.77. In contrast, ELISA and CIA showed a moderate qualitative agreement in IgG a&bgr;2GP1 detection with a kappa value of 0.2. Notably, significantly higher IgG a&bgr;2GP1 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 a&bgr;2GP1 detection by CIA (IgG a&bgr;2GP1 CIA) demonstrated the highest sensitivity (63.1%), followed by IgG aCL CIA (48.8%). More importantly, IgG a&bgr;2GP1 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 a&bgr;2GP1 antibodies, especially in the detection of IgG a&bgr;2GP1 antibodies. Our findings could shed insight on the application of CIA in the laboratory diagnosis of APS in China.