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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sample (e.g., serum) to determine antineutrophil cytoplasmic antibodies to proteinase 3 (PR3-ANCA). Increased circulating levels of PR3-ANCA are used in the diagnostic of systemic vasculitis, they are also associated with extra-renal organ involvement (especially respiratory involvements), autoimmune connective tissue diseases, and Wegener\'s granulomatosis. Most patients identified with cytoplasmic-ANCA using indirect immunofluorescence, a less specific method, have antibodies to PR3-ANCA.
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