8063 – CytoBead^® ANCA

Intended Purpose

The CytoBead® ANCA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum. It detects antibodies against neutrophil cytoplasmic antigens (ANCA) and the glomerular basement membrane (GBM). The CytoBead® ANCA aids in the diagnosis of systemic vasculitis and autoimmune renal disorders. It is intended to be used alongside other clinical and laboratory findings. The assay provides sensitive and specific detection of clinically relevant autoantibodies. This allows identification of patients with ANCA-associated vasculitis or anti-GBM disease. It helps differentiate between autoimmune conditions, supports early diagnosis, and guides treatment decisions. The test can also monitor disease activity, progression, and response to therapy. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Autoantibodies directed against components of the cell nucleus are characteristic of systemic autoimmune diseases. These include systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis.

Detection of autoantibodies in patient samples, such as plasma or serum, is well established. It plays an essential role in diagnosing systemic autoimmune diseases. CytoBead® ANCA is used for differential diagnosis of ANCA-associated vasculitis and systemic vasculitis. These include Granulomatosis with Polyangiitis, Microscopic Polyangiitis, and Eosinophilic Granulomatosis with Polyangiitis. It is also used for diagnosing autoimmune renal disorders, such as Goodpasture syndrome.