50411 – DotDiver Anti-Phospholipid IgM

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.

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. ß2 glycoprotein-I (ß2 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 ß2 GP-I, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies.

Line immunoassays are frequently used for the determination of specific antibodies directed against multiple antigens. The test strips are coated with various antigens in consistent intervals. If antibodies are present in the patient´s sample, they bind to the respective antigens. A secondary antibody conjugated with the enzyme horseradish peroxidase detects the generated immune complexes. A colorless substrate is converted into a colored, insoluble product. The signal intensity of the precipitated reaction product is proportional to the antibody activity in the sample.

The DotDiver Anti-Phospholipid IgM is designed for semi-automated use with the DotDiver instrument.

The GA Generic Assays DotDiver2.0 is a fully automated processor of Line and Dot immunoassays. The small footprint renders the device an ideal solution for laboratories with small space. With a unique software design, the device provides a completely hands-free experience for quantitative, semi-quantitative and qualitative testing via repeated diving of the antigen coated strips into the ready to use cartridges. This special setup provides an optimal reaction environment with reduced assay processing and result analysis time for up to 24 different tests or samples simultaneously.