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Title: International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies
Authors: Agmon-Levin, Nancy
Damoiseaux, Jan
Kallenberg, Cees
Sack, Ulrich
Witte, Torsten
Herold, Manfred
Bossuyt, Xavier
Musset, Lucille
Cervera, Ricard
Plaza-Lopez, Aresio
Dias, Carlos
Sousa, Maria Jose
Radice, Antonella
Eriksson, Catharina
Hultgren, Olof
Viander, Markku
Khamashta, Munther
Regenass, Stephan
Coelho Andrade, Luis Eduardo [UNIFESP]
Wiik, Allan
Tincani, Angela
Ronnelid, Johan
Bloch, Donald B.
Fritzler, Marvin J.
Chan, Edward K. L.
Garcia-De la Torre, I.
Konstantinov, Konstantin N.
Lahita, Robert
Wilson, Merlin
Vainio, Olli
Fabien, Nicole
Sinico, Renato Alberto
Meroni, Pierluigi
Shoenfeld, Yehuda
Chaim Sheba Med Ctr
Tel Aviv Univ
Maastricht Univ
Univ Groningen
Univ Leipzig
Sch Med
Med Univ Innsbruck
Univ Hosp Leuven
Katholieke Univ Leuven
GH Pitie Salpetriere
Hosp Clin Barcelona
Hosp Univ Pueta Hierro Majadahonda
S Joao Hosp
Fernando Fonseca Hosp
Azienda Osped Osped San Carlo Borromeo
Umea Univ
Univ Hosp Orebro
Univ Orebro
Univ Turku
Kings Coll London
DIA Univ Spital
Universidade Federal de São Paulo (UNIFESP)
Statens Serum Inst
Spedali Civil Brescia
Univ Brescia
Uppsala Univ
Massachusetts Gen Hosp
Harvard Univ
Univ Calgary
Univ Florida
Hosp Gen Occidente Seguro Social
Univ Guadalajara
Newark Beth Israel Med Ctr UMDNJ
Univ Oulu
NordLab Oulu
CH Lyon Sud
Univ Milan
Keywords: Autoantibodies
Systemic Lupus Erythematosus
SjOgren's Syndrome
Issue Date: 1-Jan-2014
Publisher: Bmj Publishing Group
Citation: Annals of the Rheumatic Diseases. London: Bmj Publishing Group, v. 73, n. 1, p. 17-23, 2014.
Abstract: 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<0.03). Here, we formulated recommendations for the assessment and interpretation of ANA and associated antibodies. Notably, the roles of IIFA as a reference method, and the importance of defining nuclear and cytoplasmic staining, were emphasised, while the need to incorporate alternative automated methods was acknowledged. Various approaches to overcome discrepancies between methods were suggested of which an improved bench-to-bedside communication is of the utmost importance. These recommendations are based on current knowledge and can enable harmonisation of local algorithms for testing and evaluation of ANA and related autoantibodies. Last but not least, new more appropriate terminologies have been suggested.
ISSN: 0003-4967
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