ANCA Formalin-Fixed

Intended Use

The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine®. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA-associated vasculitis (AAV). All suggested results obtained with dIFine® must be confirmed by a trained operator.

Registration / Clearance

FDA Cleared

CE Marked