5012 – Anti-Phospholipid 10 Dot

Highlights

• Detection of IgG antibodies against IgG and/or IgM antibodies against phospholipids and serum proteins
• Line immunoassay for simultaneous multi-antigen testing
• Quality assured handling in routine laboratories
• Ready-to-use test strips (exception: buffer), color- and barcoded reagents
• Aids in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings
• Differentiates antibodies against phospholipids only versus those requiring ß2-GP I cofactor
• High precision and reproducibility within the measurement range
• CE marked
• Automatable

Intended Use

The Anti-Phospholipid 10 Dot is a qualitative line immunoassay for the determination of IgG or IgM antibodies against phospholipids and serum proteins in human serum. The Anti-Phospholipid 10 Dot is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings. It provides fast and reliable information to support diagnosis in patients. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Anti-phospholipid antibody syndrome (APAS) is an autoimmune disorder characterized by clinical manifestations such as thrombocytopenia, arterial or venous thrombosis, and recurrent fetal loss. It may also occur in association with systemic lupus erythematosus (SLE). A key feature of APAS is the presence of autoantibodies directed against negatively charged phospholipids. Clinicians widely use and have firmly established autoantibody detection, which plays an essential role in diagnosing systemic autoimmune diseases

Pathophysiological Background

In autoimmune patients, phospholipid antibodies primarily recognize phospholipids bound to plasma protein cofactors such as beta-2-glycoprotein I (β2GPI). This serum protein, with a molecular weight of approximately 50 kDa, influences platelet aggregation and coagulation processes.

Negatively charged phospholipids, including cardiolipin, interact with the positively charged fifth domain of β2GPI. This interaction induces conformational changes in the protein and creates new epitopes that autoimmune phospholipid antibodies recognize.

Clinical Diagnostic Implications

Clinicians most frequently determine anti-cardiolipin antibodies when diagnosing APAS. However, antibodies against other phospholipids also provide important diagnostic information. Physicians use these additional markers particularly for differential diagnosis when anti-cardiolipin results are negative, thereby improving overall diagnostic accuracy.