50411 – DotDiver Anti-Phospholipid IgM

Intended Purpose

The DotDiver Anti-Phospholipid IgM is a qualitative line immunoassay for the determination of IgM antibodies against phospholipids and serum proteins in human serum. The DotDiver Anti-Phospholipid IgM 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 semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

APAS, an autoimmune disorder evident by clinical symptoms such as thrombocytopenia, arterial (venous) thrombosis, and recurrent foetal loss, as well as systemic lupus erythematosus (SLE) is characterized by the presence of autoantibodies reactive to negatively charged phospholipids. In autoimmune patients, phospholipid antibodies seem to recognize phospholipids associated with plasma protein cofactors, e.g. β2 glycoprotein-I (β2 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 β2 GP-I, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies.