Application Note: ERM®-DA483/IFCC: Use of ERM- DA483/IFCC for the Quantification of Immunoglobulin G proteinase 3 anti-neutrophil cytoplasmic autoantibodies
ERM-DA483/IFCC is a serum protein reference material intended for the standardisation of measurements of 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 patients with microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and renal-limited rapidly progressive glomerulonephritis [1, 2].
The marked diversity in the response of methods available for analysis and the materials used for assay calibration, mandate for a certified reference material (CRM).
The EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC) requires traceability of calibrants and control materials to reference measurement procedures and/or reference materials of higher order.
A CRM is required to have an assigned value that is metrologically traceable, and accompanied by an uncertainty statement. The stability and homogeneity with respect to the certified property must be verified, and the CRM must be commutable [3]. These attributes are particularly challenging for serum protein calibrants, as they form a mixture of interacting proteins with different isoforms and complexes.
MONOGIOUDI Evanthia;
2017-09-13
European Commission
JRC107002
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