4028 – ANCA Dot

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 ANCA Dot is a qualitative dot immunoassay for the detection of IgG antibodies against myeloperoxidase (MPO), proteinase 3 (PR3), and glomerular basement membrane (GBM) in human serum. The assay serves as an aid in the diagnosis of systemic vasculitis and autoimmune renal disorders when used in conjunction with clinical findings and other laboratory results. The immunoassay is intended for manual professional in vitro diagnostic use and supports both visual interpretation and automated image analysis using Blot Galaxy software or its equivalents.

Diagnostic Relevance

Systemic vasculitides comprise a group of autoimmune disorders characterized by inflammation of blood vessel walls, leading to structural damage and impaired organ function. Anti-neutrophil cytoplasmic antibodies (ANCA) play a key role in the serological assessment of these diseases. Based on their immunofluorescence patterns on ethanol-fixed neutrophils, ANCA are classified as cytoplasmic (cANCA) or perinuclear (pANCA), which correlate with specific target antigens.

Antibodies against proteinase 3 (PR3) show high specificity for granulomatosis with polyangiitis, while antibodies against myeloperoxidase (MPO) occur in several vasculitic conditions, including microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis. The simultaneous detection of PR3 and MPO antibodies supports differential diagnosis within the spectrum of ANCA-associated vasculitis.

Goodpasture syndrome represents a life-threatening autoimmune disease characterized by rapidly progressive glomerulonephritis and pulmonary hemorrhage. Pathogenic antibodies against the glomerular basement membrane (GBM) bind to collagen IV and cause direct renal damage. Detection of anti-GBM antibodies enables reliable differentiation of Goodpasture syndrome from other causes of glomerulonephritis and pulmonary bleeding. This information supports prompt diagnosis and appropriate clinical management.