Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

This category covers in vitro diagnostic kits designed to detect anti-neutrophil cytoplasmic antibodies targeting myeloperoxidase in clinical samples. These enzyme immunoassay-based systems are used to support the diagnosis and monitoring of autoimmune conditions, particularly vasculitides such as granulomatosis with polyangiitis. The tests provide qualitative or quantitative results to help clinicians assess antibody presence and levels.

These devices are supplied as complete test kits containing reagents, calibrators, and controls necessary for performing the assay. They are regulated as in vitro diagnostic medical devices and must meet applicable regional classification and conformity requirements. The category includes various commercial systems that follow the enzyme immunoassay methodology for detecting MPO-ANCA antibodies.