ANA as an entry criterion for the classification of SLE

David S. Pisetsky, Xavier Bossuyt, Pier Luigi Meroni

Research output: Contribution to journalReview articlepeer-review


Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease with highly variable clinical and immunological manifestations. In the classification of patients with this condition, the presence of an antinuclear antibody (ANA) is an important element, with new criteria from the American College of Rheumatology and European League against Rheumatism positioning ANA positivity by an immunofluorescence assay on HEp2-cells (HEp2-IFA) or by an equivalent solid phase assay as the entry criterion. This positioning is based on assumptions about the frequency of ANA positivity in SLE as well as the reliability of the assays. Studies indicate that these assumptions are still a matter of uncertainty since both types of assay show considerable variability and patients with SLE may display negative results in ANA testing. These findings suggest caution in positioning ANA positivity as an entry criterion for classification and point to the value of alternative serological approaches for ANA determinations.

Original languageEnglish
Article number102400
JournalAutoimmunity Reviews
Issue number12
Publication statusPublished - Dec 2019


  • Antinuclear antibody
  • Classification criteria
  • HEp2 immunofluorescence assay
  • Solid phase assays
  • Systemic lupus erythematosus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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