Abstract

In this study, we evaluated the clinical performance of anti-β2-glycoprotein 1 domain 1 antibodies (aβ2GP1-D1) in the diagnosis of antiphospholipid syndrome (APS). Sera from 229 subjects were tested, including 35 patients with primary APS, 51 patients with APS associated to other diseases, 30 patients with non-APS thrombosis, 32 patients with non-APS pregnancy-related morbidity, 42 patients with systemic lupus erythematosus, and 39 healthy controls (HC). Serum IgG aβ2GP1-D1, IgG/IgM anti-cardiolipin (aCL) and IgG/IgM aβ2GP1 were measured by a chemiluminescence assay. The levels of IgG aβ2GP1-D1 were significantly increased in patients with APS, compared with disease controls and HCs (p < 0.001). Significant correlation was identified between IgG aβ2GP1-D1 and IgG aβ2GP1 (p < 0.0001), indicating IgG aβ2GP1-D1 were the predominant domain-specific antibodies in IgG aβ2GP1 family. Importantly, aβ2GP1-D1, but not aβ2GP1 non-D1, was significantly correlated with thrombotic events. Interestingly, no significant correlation between IgG aβ2GP1-D1 and obstetric complications was observed. Additionally, significantly higher levels of IgG aβ2GP1-D1 were found in patients with triple aPL positivity, compared with patients with double and single aPL positivity. Our findings suggest a potential role of IgG aβ2GP1-D1 in identifying APS patients with high risk of thrombosis, shedding insight on the introduction of IgG aβ2GP1-D1 in China.

Highlights

  • Antiphospholipid syndrome (APS) is an autoimmune disease characterized by recurrent thrombosis in arteries and veins and/or pregnancy morbidity

  • When the manufacturer’s recommended cut off of 20 chemiluminescent units (CU) was applied, the presence of IgG anti-β 2-glycoprotein 1 (aβ 2GP1)-domain 1 (D1) antibodies in patients with primary APS (PAPS), APS associated to other diseases (APSAOD), non-antiphospholipid syndrome (APS) thrombosis, non-APS pregnancy-related morbidity (PRM), and systemic lupus erythematosus (SLE) were 48.6%, 45.1%, 0, 0, and 7.1%, respectively (Table 1)

  • Previous studies have shown that abs specific to β 2GP1-D1 are associated with thrombosis and pregnancy morbidity[6,7,8,9,10,11]

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Summary

Introduction

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by recurrent thrombosis in arteries and veins and/or pregnancy morbidity. APLs represent a heterogeneous population of autoantibodies that target phospholipids, phospholipid-binding plasma proteins, and/or plasma protein-phospholipid complexes. Among those aPLs, anti-β 2-glycoprotein 1 (aβ 2GP1) antibodies have been increasingly recognized as the most clinically relevant autoantibodies in APS1. Aβ 2GP1-D1 antibodies have attracted particular interest for its prognostic potential for thrombosis and pregnancy complications, the number of studies is still limited, and its clinical value needs to be verified in patients with different ethnic/geographic background. A novel chemiluminescence immunoassay (CIA) based assay for detecting aβ 2GP1-D1 antibodies has recently developed. We utilized the CIA assay to evaluate the role of aβ 2GP1-D1 antibodies in the diagnosis of APS, with a particular interest in their prognostic value for thrombosis and pregnancy complications

Methods
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