4036 – Anti-ß2-GP-I Screen

Highlights

• Microtiter plate coated with purified human β2-glycoprotein I (β2GPI)
• Semi-quantitative detection of IgG, IgM, and IgA antibodies against β2GPI
• Supports the diagnosis of antiphospholipid syndrome (APS) together with clinical and laboratory findings
• Aid in the diagnosis of antiphospholipid antibody syndrome (APAS)
• Manual professional in vitro diagnostic use
• CE-marked

Intended Purpose

The Anti-ß2-GP-I Screen is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG, IgM, and IgA antibodies against β2-glycoprotein I (β2GP I) in human serum. The ELISA assay supports clinicians in diagnosing antiphospholipid syndrome (APS) and related autoimmune disorders, such as systemic lupus erythematosus (SLE), when used in conjunction with other clinical and laboratory findings, in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Antiphospholipid syndrome (APS) is an autoimmune disorder that causes clinical symptoms such as arterial or venous thrombosis, thrombocytopenia, and recurrent fetal loss. In both primary APS and secondary APS associated with systemic lupus erythematosus (SLE), patients produce autoantibodies directed against phospholipid-binding proteins, particularly β2-glycoprotein I (β2GPI). Detection of these antibodies is a well-established laboratory marker that plays a crucial role in diagnosing APS, assessing thrombotic risk, and informing clinical management.

In patients with antiphospholipid syndrome (APS), autoantibodies are primarily directed against β2-glycoprotein I (β2GPI), a plasma protein that binds to negatively charged phospholipids. Binding of β2GPI to phospholipids induces conformational changes that expose epitopes recognized by anti-β2GPI autoantibodies. Detection of IgG, IgM, and IgA antibodies against β2-GPI is an established laboratory marker that supports the diagnosis of APS in conjunction with clinical findings and other laboratory results. Quantification of these antibodies also supports the assessment of thrombotic risk and obstetric complications.