Antigen-specific ANCA ELISAs have different sensitivities for active and treated vasculitis and for nonvasculitic disease

Am J Clin Pathol. 2008 Jan;129(1):42-53. doi: 10.1309/F6L4C48RHFMT4AAU.

Abstract

This study evaluated the performance of 12 assays for antineutrophil cytoplasmic antibodies (ANCA) directed against proteinase 3 (PR3) and myeloperoxidase (MPO) in 55 active and 68 treated cases of vasculitis and in nonvasculitic disease. It examined within- and between-assay precision; binding curves, binding levels, and interassay consistency; and sensitivity, specificity, and receiver operating characteristic analysis. All assays were highly sensitive for active vasculitis (median, 94%; range, 91%-96%), but sensitivities were more varied in treated disease (median, 69%; range, 57%-82%). Binding curves and binding levels were also very variable in PR3-ANCA and MPO-ANCA assays. This has implications for studies correlating ANCA levels with disease activity and in developing ANCA-based treatment guidelines. PR3-ANCA and MPO-ANCA assays need to be standardized as a matter of urgency, but in the meantime, individual laboratories must understand the limitations of the assays used, especially with low-level ANCA in treated vasculitis and nonvasculitic disease.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Antineutrophil Cytoplasmic / immunology*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Epitopes
  • Fluorescent Antibody Technique, Indirect
  • Granulomatosis with Polyangiitis / diagnosis*
  • Granulomatosis with Polyangiitis / drug therapy
  • Granulomatosis with Polyangiitis / immunology*
  • Humans
  • Myeloblastin / blood
  • Myeloblastin / immunology
  • Neutrophils / metabolism
  • Neutrophils / pathology
  • Peroxidase / blood
  • Peroxidase / immunology
  • Prognosis
  • ROC Curve
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Antibodies, Antineutrophil Cytoplasmic
  • Epitopes
  • Peroxidase
  • Myeloblastin