title: Development and validation of a lateral flow assay (LFA) for the determination of IgG-antibodies to Pr3 (cANCA) and MPO (pANCA).
abstract: The timely diagnosis of vasculopathies, such as granulomatosis with polyangiitis, has important implications for the favorable clinical outcome of these diseases. In the clinical setting, autoantibodies to proteinase 3 (Pr3) and myeloperoxidase (MPO) have been shown to be valuable adjuncts to an early and accurate diagnosis. The sensitive and specific detection of anti-Pr3 and anti-MPO was shown using a point of care device that employed rapid Lateral Flow Technologies. The validation of the lateral flow assay (LFA) was performed with serum samples collected in two Reference Laboratories and showed excellent results that were comparable to widely accepted and used ELISA. The advantage of the LFA is the flexibility to be used as an economical, point of care diagnostic device, features that are especially important for an early and accurate diagnosis and the prompt initiation of appropriate treatment so as to avoid inevitable development of undue complications of these diseases such as disseminated organ involvement, e.g. renal failure.
authors.affiliation: Dr. Fooke Laboratorien GmbH, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Offermann
authors.affiliation: Technical University Dresden, Institute of Immunology, Dresden, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Conrad
authors.affiliation: Faculty of Medicine, University of Calgary Calgary, Alberta, Canada.
authors.forename: M J
authors.initials: MJ
authors.lastname: Fritzler
authors.affiliation: Dr. Fooke Laboratorien GmbH, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Fooke Achterrath
mesh_terms: D056648:Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis / Q000097:blood / Q000175:diagnosis* / Q000201:enzymology / Q000276:immunology; D019268:Antibodies, Antineutrophil Cytoplasmic / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay; D019084:Fluorescent Antibody Technique, Indirect; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D007074:Immunoglobulin G / Q000097:blood*; D008163:Luminescent Measurements; D053146:Myeloblastin / Q000276:immunology*; D009195:Peroxidase / Q000276:immunology*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
chemical_list: D019268:Antibodies, Antineutrophil Cytoplasmic; D015415:Biomarkers; D007074:Immunoglobulin G; D009195:Peroxidase; D053146:Myeloblastin
keywords: Autoantibodies; Lateral flow assay; Myeloperoxidase, MPO; Proteinase 3, Pr3; cANCA; pANCA