4036 – Anti-ß2-GP-I Screen

Highlights

• Use of purified phospholipids and β2-glycoprotein I
• Detects antibodies to cardiolipin, phosphatidyl-serine, phosphatidyl-inositol,  phosphatidylethanolamine, and phosphatidic acid
• Aids in the diagnosis of anti-phospholipid antibody syndrome (APAS) and related   autoimmune disorders, including SLE
• Supports risk assessment for thrombosis and recurrent fetal loss
• Differentiates autoimmune phospholipid antibodies from those appearing in  infectious diseases
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

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 (β2-GP I) in human serum. The ELISA assay is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) and related autoimmune disorders, such as systemic lupus erythematosus (SLE), in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Anti-phospholipid antibody syndrome (APAS) is an autoimmune disorder that causes clinical symptoms such as arterial or venous thrombosis, thrombocytopenia, and recurrent fetal loss. In both primary APAS and secondary APAS associated with systemic lupus erythematosus (SLE), patients produce autoantibodies that target negatively charged phospholipids. Detection of these antibodies is a well-established laboratory marker that plays a crucial role in diagnosing APAS, assessing thrombotic risk, and informing clinical management.

In patients with autoimmune conditions, phospholipid antibodies often recognize phospholipids in complex with plasma protein cofactors, particularly β2-glycoprotein I (β2-GP-I), a 50 kDa serum protein involved in platelet aggregation and coagulation. The positively charged fifth domain of β2-GP-I interacts with negatively charged phospholipids such as cardiolipin. This interaction triggers conformational changes in β2-GP-I, exposing new epitopes that autoimmune phospholipid antibodies can recognize. Quantifying IgG, IgM, and IgA anti-β2-GP-I antibodies can provide additional insight into disease activity, risk of thrombosis, and potential obstetric complications, making the Anti-β2-GP-I Screen an important and reliable tool for patient evaluation.