International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies

Nancy Agmon-Levin, Jan Damoiseaux, Cees Kallenberg, Ulrich Sack, Torsten Witte, Manfred Herold, Xavier Bossuyt, Lucille Musset, Ricard Cervera, Aresio Plaza-Lopez, Carlos Dias, Maria José Sousa, Antonella Radice, Catharina Eriksson, Olof Hultgren, Markku Viander, Munther Khamashta, Stephan Regenass, Luis Eduardo Coelho Andrade, Allan WiikAngela Tincani, Johan Rönnelid, Donald B. Bloch, Marvin J. Fritzler, Edward K L Chan, I. Garcia-De La Torre, Konstantin N. Konstantinov, Robert Lahita, Merlin Wilson, Olli Vainio, Nicole Fabien, Renato Alberto Sinico, Pierluigi Meroni, Yehuda Shoenfeld

Research output: Contribution to journalArticlepeer-review


Anti-nuclear antibodies (ANA) are fundamental for the diagnosis of autoimmune diseases, and have been determined by indirect immunofluorescence assay (IIFA) for decades. As the demand for ANA testing increased, alternative techniques were developed challenging the classic IIFA. These alternative platforms differ in their antigen profiles, sensitivity and specificity, raising uncertainties regarding standardisation and interpretation of incongruent results. Therefore, an international group of experts has created recommendations for ANA testing by different methods. Two groups of experts participated in this initiative. The European autoimmunity standardization initiative representing 15 European countries and the International Union of Immunologic Societies/World Health Organization/Arthritis Foundation/Centers for Disease Control and Prevention autoantibody standardising committee. A three-step process followed by a Delphi exercise with closed voting was applied. Twenty-five recommendations for determining ANA (1-13), anti-double stranded DNA antibodies (14-18), specific antibodies (19-23) and validation of methods (24-25) were created. Significant differences between experts were observed regarding recommendations 24-25 ( p

Original languageEnglish
Pages (from-to)17-23
Number of pages7
JournalAnnals of the Rheumatic Diseases
Issue number1
Publication statusPublished - Jan 2014

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy


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