50401 – DotDiver Anti-Phospholipid IgG

Highlights

• Use of highly purified phospholipids and serum proteins (cardiolipin, phosphatidic acid, phosphatidylethanolamine, phosphatidyl-glycerol, phosphatidyl-inositol, phosphatidyl-serine, ß2-glycoprotein I, annexin V, prothrombin)
• Ready-to-use test strips and cartridges for semi-automated handling
• Positive and cut-off controls included for reliable results
• Detection of IgG antibodies relevant for anti-phospholipid antibody syndrome (APAS)
• High sensitivity and specificity for autoimmune phospholipid antibodies
• Suitable for routine laboratory testing
• CE marked

Intended Use

The DotDiver Anti-Phospholipid IgG is a qualitative line immunoassay for the detection of IgG antibodies against phospholipids and associated serum proteins in human serum. It is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) and in the assessment of patients with systemic autoimmune disorders such as systemic lupus erythematosus (SLE), in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The and professional in vitro diagnostic use.

Diagnostic Relevance

Patients with anti-phospholipid antibody syndrome (APAS) experience clinical features such as arterial or venous thrombosis, thrombocytopenia, and recurrent fetal loss. In APAS and SLE, the immune system produces IgG autoantibodies that target negatively charged phospholipids.

In these patients, phospholipid antibodies often recognize phospholipids in complex with plasma protein cofactors, such as β2-glycoprotein I (β2 GP-I), a 50 kDa serum protein that plays a critical role in platelet aggregation and coagulation. Negatively charged phospholipids, such as cardiolipin, interact with the positively charged fifth domain of β2 GP-I. This interaction induces conformational changes in β2 GP-I, creating new epitopes that are specifically recognized by autoimmune phospholipid antibodies.

Detection of these autoantibodies is clinically important for confirming APAS, differentiating it from other thrombotic or autoimmune conditions, and guiding appropriate clinical management. The DotDiver Anti-Phospholipid IgG assay provides a sensitive and reliable method for semi-automated testing in routine laboratories.