V.A. Nasonova Research Institute of Rheumatology, Laboratory of Vascular Rheumatology.
Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia, Department of Rheumatology.
Klin Lab Diagn. 2021 Sep 10;66(9):546-551. doi: 10.51620/0869-2084-2021-66-9-546-551.
Antiphospholipid antibodies (aPL) are a family of different autoantibodies that lead to recurrent vascular thrombosis of any localization and caliber, and/or obstetric pathology - fetal loss. Serological markers of antiphospholipid syndrome (APS) include only three types of aPL - lupus anticoagulant (VA), antibodies to cardiolipin (aCL) classes IgG and IgM, antibodies to β2-glycoprotein1 (aβ2GP1) classes IgG and IgM. Medium and high levels of aCL and aß2HP1 (IgG and / or IgM) were selected as serological markers of APS in the 2006 classification criteria. However, the threshold of values used from low to moderately high levels has not been standardized. aPL standardization issues are still unresolved, resulting in heterogeneous results of the ongoing studies. The aim of the study was to assess the comparability IgG/IgM-aCL and IgG/IgM-ab2GP1 by enzyme-linked immunosorbent assay and chemiluminescent analysis in patients with APS with and without (systemic lupus erythematosus) SLE. The study included 70 patients (49 women and 21 men) with APS, of which 21 (30%) were with primary APS (pAPS) and 49 (70%) with APS in combination with SLE. All study participants underwent determination of IgG/IgM-aCL and IgG/IgM-aβ2GP1 by enzyme-linked immunosorbent. A study was performed by the chemiluminescent analysis: IgG/IgM-aCL - in 70 patients; IgG/IgM-aβ2GP1 - in 69 patients. Results. According to preliminary data, the determination of IgG-aCL and IgG-aβ2GP1 by the chemiluminescent analysis is informative in assessing positivity according to the manufacturer, compared with the enzyme-linked immunosorbent (p < 0.05). However, when taking into account the levels of antibody positivity determined by enzyme-linked immunosorbent, the level of positive values according to chemiluminescent analysis was much higher than the performance of the manufacturer.
抗磷脂抗体（aPL）是一组不同的自身抗体，可导致任何部位和大小的血管复发性血栓形成，以及/或产科病理学-胎儿丢失。抗磷脂综合征（APS）的血清学标志物仅包括三种类型的 aPL-狼疮抗凝物（VA）、抗心磷脂（aCL）类 IgG 和 IgM 抗体、抗β2-糖蛋白 1（aβ2GP1）类 IgG 和 IgM 抗体。中高滴度的 aCL 和 aß2HP1（IgG 和/或 IgM）被选为 2006 年分类标准中 APS 的血清学标志物。然而，从中低至高滴度值的阈值尚未标准化。aPL 标准化问题仍未解决，导致正在进行的研究结果存在差异。本研究旨在评估酶联免疫吸附法和化学发光分析在伴有和不伴有系统性红斑狼疮（SLE）的 APS 患者中 IgG/IgM-aCL 和 IgG/IgM-ab2GP1 的可比性。该研究纳入了 70 名 APS 患者（49 名女性和 21 名男性），其中 21 名（30%）为原发性 APS（pAPS），49 名（70%）为 APS 合并 SLE。所有研究参与者均接受 IgG/IgM-aCL 和 IgG/IgM-aβ2GP1 的酶联免疫吸附测定。通过化学发光分析进行了一项研究：70 名患者进行 IgG/IgM-aCL 测定；69 名患者进行 IgG/IgM-aβ2GP1 测定。结果。根据初步数据，与酶联免疫吸附法相比，化学发光分析法测定 IgG-aCL 和 IgG-aβ2GP1 在评估制造商的阳性率方面更具信息性（p<0.05）。然而，当考虑到酶联免疫吸附法确定的抗体阳性水平时，根据化学发光分析的阳性值水平远高于制造商的性能。
