4014 – Anti-Cardiolipin Screen

Highlights

• Use of cardiolipin complex as coating antigen
• Semi-quantitative detection of IgG, IgM, and IgA antibodies in human serum
• Aids in the diagnosis of anti-phospholipid antibody syndrome (APAS) alongside clinical and laboratory findings
• Detects disease-relevant autoantibodies recognizing cardiolipin–β2-glycoprotein I complexes
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

The Anti-Cardiolipin Screen is a semi-quantitative immunoassay for detecting IgG, IgM, and IgA antibodies against cardiolipin in human serum. The assay serves as an aid in diagnosing anti-phospholipid antibody syndrome (APAS) and related autoimmune disorders, including systemic lupus erythematosus (SLE), when used alongside clinical evaluation, imaging studies, and other laboratory findings. It provides reliable and reproducible quantification of anti-cardiolipin antibodies, supporting clinicians in patient management and risk assessment. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

APAS is an autoimmune disorder characterized by clinical manifestations such as arterial or venous thrombosis, thrombocytopenia, and recurrent fetal loss. Both primary APAS and secondary APAS associated with SLE involve the presence of autoantibodies reactive to negatively charged phospholipids, including cardiolipin. Detection of these antibodies is a critical tool for diagnosing APAS and assessing the risk of thrombotic or obstetric complications.

In autoimmune patients, cardiolipin antibodies often recognize cardiolipin in complex with plasma protein cofactors such as β2-glycoprotein I (β2-GP-I), a 50 kDa serum protein involved in platelet aggregation and coagulation. The interaction between negatively charged cardiolipin and the positively charged fifth domain of β2-GP-I induces conformational changes in the protein, creating novel epitopes that are specifically recognized by autoimmune phospholipid antibodies. Quantification of these antibodies provides essential information on disease activity, progression, and potential systemic involvement, supporting clinical decision-making and patient monitoring.