5018 – DotDiver ANCA

Highlights

• Simultaneous detection of IgG antibodies to MPO, PR3, and GBM
• Qualitative dot immunoassay for the determination of IgG antibodies in human serum
• Supports the diagnosis of systemic vasculitis and autoimmune renal disorders in conjunction with clinical and laboratory findings
• Ready-to-use reagents (except wash buffer)
• Designed for semi-automated processing with the DotDiver instrument
• Professional in vitro diagnostic use
• CE-marked

Intended Purpose

The DotDiver ANCA is a qualitative dot immunoassay for the determination of IgG antibodies against Myeloperoxidase (MPO), Proteinase 3 (PR3) and Glomerular Basement Membrane Protein (GBM) in human serum. The DotDiver ANCA is intended as an aid in the diagnosis of systemic vasculitis and autoimmune renal disorders in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument and is intended for professional in vitro diagnostic use.

Diagnostic Relevance

Anti-neutrophil cytoplasmic antibodies (ANCA) are a group of autoantibodies directed against cytoplasmic components of neutrophilic granulocytes and are associated with inflammatory vascular diseases. Based on their immunofluorescence pattern on ethanol-fixed human granulocytes, ANCA are classified as cytoplasmic (cANCA) or perinuclear (pANCA).

Proteinase 3 (PR3), a 29 kDa serine proteinase, is the principal target antigen of cANCA. Anti-PR3 antibodies are highly specific for granulomatosis with polyangiitis (formerly Wegener’s granulomatosis). Myeloperoxidase (MPO) is the major target antigen of pANCA, and anti-MPO antibodies are associated with several forms of ANCA-associated vasculitis, including microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA, formerly Churg–Strauss syndrome), polyarteritis nodosa, and rapidly progressive glomerulonephritis (RPGN).

Goodpasture syndrome is a severe autoimmune disorder characterized by rapidly progressive glomerulonephritis, pulmonary haemorrhage, and the presence of autoantibodies directed against the glomerular basement membrane (GBM). These antibodies target the non-collagenous (NC1) domain of the α3 chain of type IV collagen and are the primary pathogenic autoantibodies in Goodpasture syndrome. Detection of anti-GBM antibodies is essential for differentiating Goodpasture syndrome from other causes of glomerulonephritis and pulmonary haemorrhage. The simultaneous determination of antibodies against PR3, MPO, and GBM supports the differential diagnosis of systemic vasculitis and autoimmune renal disorders in conjunction with other clinical and laboratory findings.