4016 – Anti-Cardiolipin

Highlights

• Use of  IgG and/or IgM antibodies against cardiolipin
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Aids in the diagnosis of anti-phospholipid antibody syndrome (APAS)
• Excellent diagnostic sensitivity and specificity shortly after onset of the disease
• Detection of cardiolipin antibodies associated with β2-glycoprotein I
• High precision and linearity within the measurement range
• CE marked
• Fully automatable

Intended Purpose

The Anti-Cardiolipin is a quantitative immunoassay for the determination of IgG and/or IgM antibodies against cardiolipin in human serum. The Anti-Cardiolipin is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS), in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune patients with anti-phospholipid antibody syndrome (APAS) or systemic lupus erythematosus (SLE) produce autoantibodies that react to negatively charged phospholipids. Clinicians routinely detect these antibodies, which play an essential role in diagnosing systemic autoimmune diseases.

In autoimmune patients, cardiolipin antibodies seem to recognize cardiolipin associated with plasma protein cofactors, e.g. b₂ glycoprotein-I (b₂ GP-I), a serum protein with a molecular weight of ca. 50 kDa, that affects platelet aggregation and coagulation. Negatively charged phospholipids such as cardiolipin interact with the positively charged fifth domain of b₂ GP-I, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies.

Publications

• Romero-Sánchez et al., (2022) Analysis of ANA-DFS-70 Pattern in a Large Cohort of Autoimmune Autoinflammatory Diseases from Colombia