欧洲标准局 参考物质 应用说明 ERM-DA483 IFCC application note.pdfVIP

Application Note ® ERM -DA483/IFCC Author : Evanthia Monogioudi European Commission – Joint Research Centre Retieseweg 111, 2440 Geel, Belgium Email: JRC-RM-DISTRIBUTION@ec.europa.eu Use of ERM- DA483/IFCC for the Quantification of Immunoglobulin G proteinase 3 anti-neutrophil cytoplasmic autoantibodies The certified reference material (CRM) ERM-DA483/IFCC [1] is intended to be used for the calibration of immunoassay-based in vitro diagnostic devices. INTRODUCTION the CRM must be commutable [3]. These attributes are particularly challenging for ERM-DA483/IFCC is a serum protein reference material intended for the serum protein calibrants, as they form a standardisation of measurements of mixture of interacting proteins with different isoforms and complexes. Immunoglobulin G proteinase 3 anti- neutrophil cytoplasmic autoantibodies (IgG PR3 ANCA). These are antibodies against the neutrophil enzyme proteinase 3. They are detected as anti-neutrophil cytoplasmic antibodies and represent the cornerstones of the diagnosis of small vessel associated vasculitis. IgG PR3 ANCA are found in about 80 % of patients with granulomatosis with polyangiitis (GPA), and also in about 35 % of