How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative

C.A. von Muhlen*, I. Garcia-De La Torre, M. Infantino, J. Damoiseaux, L.E.C. Andrade, O.G. Carballo, K. Conrad, P.L.C. Francescantonio, M.J. Fritzler, M. Herold, W. Klotz, W.D. Cruvinel, T. Mimori, M. Satoh, L. Musset, E.K.L. Chan

*Corresponding author for this work

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Abstract

Results of the anti-nuclear antibodies-indirect immunofluorescence assay (anti-cell antibodies test) on HEp-2 cell substrates should be communicated to clinicians in a standardized way, adding value to laboratory findings and helping with critical clinical decisions. This paper proposes a test report based on the practices informed by 118 laboratories in 68 countries, with recommendations from the International Consensus on ANA Patterns (ICAP) group. Major focus is placed on the report format containing endpoint titers, immunofluorescence patterns together with anti-cell (AC) nomenclature, remarks on follow-up or reflex testing, and possible other autoantibody associations. ISO 15,189 directives were integrated into the test report. Special situations addressed include serum screening dilutions and endpoint titers, relevance of immunofluorescence patterns with special attention to cytoplasmic patterns, mixed and compound patterns, and how to report different titers corresponding to multiple patterns or autoantibodies in the same sample. This paper suggests a subtitle for the HEp-2-IIFA, namely anti-cell antibodies test, which could gradually substitute the original outdated ANA nomenclature. This ICAP pro forma report represents a further step in harmonizing the way relevant clinical information could be provided by laboratories.
Original languageEnglish
Pages (from-to)594-608
Number of pages15
JournalImmunologic Research
Volume69
Issue number6
Early online date9 Oct 2021
DOIs
Publication statusPublished - Dec 2021

Keywords

  • ANA patterns
  • ANA test report
  • Anti-cell antibodies test
  • International Consensus on ANA Patterns
  • HEp-2 cell indirect immunofluorescence assay (HEp-2 IIFA)
  • Report of ANA test
  • INDIRECT IMMUNOFLUORESCENCE
  • INTERNATIONAL CONSENSUS
  • ANTI-DFS70 ANTIBODIES
  • PEGYLATED INTERFERON
  • HEALTHY-INDIVIDUALS
  • AUTOANTIBODIES
  • PATTERN
  • ANA
  • DIAGNOSIS
  • STANDARDIZATION

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