title: A comparative study of the diagnostic accuracy of ELISA systems for the detection of anti-neutrophil cytoplasm antibodies available in Japan and Europe.
abstract: OBJECTIVE
  Primary systemic vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA) differs in its frequency and clinical expression between Japan and Europe. We sought to ascertain whether such differences arise from the performance of enzyme-linked immunosorbent assays (ELISAs) for ANCA.
  
  
  METHODS
  Plasma samples from 64 consecutive Japanese patients with a clinical and histological diagnosis of primary systemic vasculitis including microscopic polyangiitis (MPA; n=52), Churg-Strauss syndrome (CSS; n=1), and Wegener's granulomatosis (WG; n=11), or those from disease controls with non-vasculitic glomerulonephritis (n=54) and healthy controls (n=55) were tested for the presence of myeloperoxidase (MPO) by ELISAs available in Japan (Nipro and MBL) and compared with those in Europe (Wieslab). The sensitivity and specificity were calculated for each ELISA, and its diagnostic performance was assessed by receiver operating characteristic curve analysis.
  
  
  RESULTS
  The sensitivity and specificity of either MPO-ANCA assays for a diagnosis of MPA were 90.4% and 98.2% (Nipro), 88.2% and 96.3% (MBL), and 86.5% and 99.1% (Wieslab). The overall diagnostic performance, assessed as the area under curve of the MPO-ANCA ELISAs for MPA were 0.946+/-0.022 (Nipro), 0.970+/-0.017 (MBL), and 0.971+/-0.017 (Wieslab), while that of PR3-ANCA ELISAs for WG were 0.986+/-0.025 (Nipro), 0.993+/-0.017 (MBL), and 0.916+/-0.059 (Wieslab).
  
  
  CONCLUSIONS
  The MPO-ANCA ELISAs commercially available in Japan exhibited high sensitivity and specificity for the diagnosis of ANCA-associated vasculitides and provided similar diagnostic value to those in Europe. These results facilitate further international comparison of ANCA-associated vasculitides between Japanese and European populations.
authors.affiliation: Department of Nephrology and Dialysis, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ito-Ihara
authors.forename: E
authors.initials: E
authors.lastname: Muso
authors.forename: S
authors.initials: S
authors.lastname: Kobayashi
authors.forename: K
authors.initials: K
authors.lastname: Uno
authors.forename: N
authors.initials: N
authors.lastname: Tamura
authors.forename: Y
authors.initials: Y
authors.lastname: Yamanishi
authors.forename: A
authors.initials: A
authors.lastname: Fukatsu
authors.forename: R A
authors.initials: RA
authors.lastname: Watts
authors.forename: D G I
authors.initials: DG
authors.lastname: Scott
authors.forename: D R W
authors.initials: DR
authors.lastname: Jayne
authors.forename: K
authors.initials: K
authors.lastname: Suzuki
authors.forename: H
authors.initials: H
authors.lastname: Hashimoto
mesh_terms: D019268:Antibodies, Antineutrophil Cytoplasmic / Q000032:analysis* / Q000097:blood*; D015267:Churg-Strauss Syndrome / Q000175:diagnosis / Q000208:ethnology / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards*; D005060:Europe / Q000453:epidemiology; D014890:Granulomatosis with Polyangiitis / Q000175:diagnosis / Q000208:ethnology / Q000276:immunology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D053146:Myeloblastin / Q000276:immunology; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019809:Streptavidin; D014657:Vasculitis / Q000175:diagnosis* / Q000208:ethnology / Q000276:immunology*
chemical_list: D019268:Antibodies, Antineutrophil Cytoplasmic; D019809:Streptavidin; D053146:Myeloblastin