High Sensitivity ELISA Diagnoses Wegener's Granulomatosis

Wegener's granulomatosis can now be diagnosed using a high sensitivity (hs) enzyme-linked immunosorbant assay (ELISA).

A fatal disease of unknown etiology, Wegener's granulomatosis is characterized by granuloma in the inflamed tissues of the respiratory tract, systemic vasculitis of small blood vessels, and glomerulonephritis. Anti-neutrophil cytoplasmatic antibodies (ANCA) against cytoplasmic components of neutrophil granulocytes are diagnostic markers for the disease.

Antibodies against proteinase 3 (PR3) distinguish Wegener's granulomatosis from other ANCA-associated small vessel vasculitides such as microscopic polyangiitis and Churg-Strauss syndrome. Currently, diagnosis combines indirect immunofluorescence with an antigen-specific ELISA.

A study of patients with Wegener's granulomatosis--confirmed by clinical data and biopsy results--showed that the Anti-PR3 hs ELISA had a sensitivity of 96% and specificity of 99%. The ELISA is produced by Orgentec Diagnostika (Mainz, Germany) and the results correlated perfectly with indirect immunofluorescence but were superior to immunoblot, direct, and capture ELISA.

Although sera of patients with confirmed Wegener's granulomatosis had negative results for proteinase 3 autoantibodies when tested by the conventional direct ELISA, this assay detected PR3 antibodies in 71% of these sera.

Anti-PR3 hs ELISA detects patients with localized Wegener's granulomatosis corresponding to an early stage of the disease. Due to its sensitivity, high specificity, and excellent correlation with the immunofluorescence test (IFT), the assay replaces the need for complex analysis and significantly simplifies diagnosis of ANCA.

Orgentec Diagnostika develops, produces, and distributes tests for autoimmune diagnostics. Among these tests are methods for diagnosis and therapy monitoring of rheumatic diseases, vasculitis, diabetes and autoimmune disorders of the gastrointestinal tract.


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