50411 – DotDiver Anti-Phospholipid IgM

Highlights

• Qualitative dot immunoassay for IgG antibodies against MPO, PR3, and GBM
• Uses highly purified native (MPO, PR3) and recombinant (GBM) human antigens
• Supports diagnosis of ANCA-associated vasculitis and autoimmune renal diseases
• Enables differentiation of PR3-, MPO-, and GBM-associated disorders
• Detection of disease-relevant autoantibodies in systemic vasculitis and Goodpasture syndrome
• Simultaneous analysis of multiple autoantibodies on one test strip
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

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 DotDiver2.0 instrument and  professional in vitro diagnostic use.

Diagnostic Relevance

Clinical Features of Anti-Phospholipid Antibody Syndrome (APAS)

Anti-phospholipid antibody syndrome (APAS) is an autoimmune disorder characterized by a spectrum of clinical manifestations, including arterial and venous thrombosis, thrombocytopenia, and recurrent fetal loss. APAS may present as a primary condition or in association with systemic lupus erythematosus (SLE). In affected patients, IgM autoantibodies target negatively charged phospholipids, such as cardiolipin, and can also react with phospholipids complexed with serum cofactors like β2-glycoprotein I (β2 GP-I). This 50 kDa serum protein regulates platelet aggregation and the coagulation cascade.

The interaction between negatively charged phospholipids and the positively charged fifth domain of β2 GP-I induces conformational changes in the protein, creating new epitopes that autoantibodies recognize. In addition to β2 GP-I, patients with APAS may produce IgM antibodies against other serum proteins, including annexin V and prothrombin. The presence and specificity of these autoantibodies provide important diagnostic information and can guide differential diagnosis, particularly in cases where standard anti-cardiolipin tests are negative.

DotDiver Anti-Phospholipid IgM Assay

The DotDiver Anti-Phospholipid IgM assay employs line immunoassay technology, allowing simultaneous detection of multiple antigens. The test strips contain highly purified phospholipids and serum proteins, which allow the assay to detect autoantibodies sensitively and specifically. The enzyme reaction produces a color change that visualizes binding, providing reproducible and quantifiable results. By offering reliable detection of IgM anti-phospholipid antibodies, this assay supports early diagnosis, risk assessment, and patient management in clinical settings, enabling targeted therapeutic decisions for individuals at risk of thrombotic events or pregnancy complications.