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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,25]],"date-time":"2024-01-25T09:16:23Z","timestamp":1706174183488},"reference-count":171,"publisher":"Walter de Gruyter GmbH","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,27]]},"abstract":"<jats:title>Abstract<\/jats:title>\n <jats:sec id=\"j_cclm-2023-0209_abs_001\">\n <jats:title>Objectives<\/jats:title>\n <jats:p>Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate. Newer developments on ANA testing that offer novel features adopted by some clinical laboratories include automated computer-assisted diagnosis (CAD) systems and solid phase assays (SPA).<\/jats:p>\n <\/jats:sec>\n <jats:sec id=\"j_cclm-2023-0209_abs_002\">\n <jats:title>Methods<\/jats:title>\n <jats:p>A group of experts reviewed current literature and established recommendations on methodological aspects of ANA testing. This process was supported by a two round Delphi exercise. International expert groups that participated in this initiative included (i) the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group \u201cAutoimmunity Testing\u201d; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP).<\/jats:p>\n <\/jats:sec>\n <jats:sec id=\"j_cclm-2023-0209_abs_003\">\n <jats:title>Results<\/jats:title>\n <jats:p>In total, 35 recommendations\/statements related to (i) ANA testing and reporting by HEp-2 IFA; (ii) HEp-2 IFA methodological aspects including substrate\/conjugate selection and the application of CAD systems; (iii) quality assurance; (iv) HEp-2 IFA validation\/verification approaches and (v) SPA were formulated. Globally, 95% of all submitted scores in the final Delphi round were above 6 (moderately agree, agree or strongly agree) and 85% above 7 (agree and strongly agree), indicating strong international support for the proposed recommendations.<\/jats:p>\n <\/jats:sec>\n <jats:sec id=\"j_cclm-2023-0209_abs_004\">\n <jats:title>Conclusions<\/jats:title>\n <jats:p>These recommendations are an important step to achieve high quality ANA testing.<\/jats:p>\n <\/jats:sec>","DOI":"10.1515\/cclm-2023-0209","type":"journal-article","created":{"date-parts":[[2023,3,29]],"date-time":"2023-03-29T18:51:04Z","timestamp":1680115864000},"page":"1167-1198","source":"Crossref","is-referenced-by-count":6,"title":["Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP"],"prefix":"10.1515","volume":"61","author":[{"given":"Carolien","family":"Bonroy","sequence":"first","affiliation":[{"name":"Department of Diagnostic Sciences , Ghent University , Ghent , Belgium"},{"name":"Department of Laboratory Medicine , University Hospital Ghent , Ghent , Belgium"}]},{"given":"Martine","family":"Vercammen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, AZ Sint-Jan , Brugge , Belgium"},{"name":"Research Group REIM, Vrije Universiteit Brussel , Brussels , Belgium"}]},{"given":"Walter","family":"Fierz","sequence":"additional","affiliation":[{"name":"Schweizerischer Verband der Diagnostikindustrie (SVDI-ASID) , Bern , Switzerland"}]},{"ORCID":"http:\/\/orcid.org\/0000-0001-8742-9931","authenticated-orcid":false,"given":"Luis E.C.","family":"Andrade","sequence":"additional","affiliation":[{"name":"Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de Sao Paulo , Sao Paulo , Brazil"},{"name":"Immunology Division, Fleury Medicine and Health Laboratories , Sao Paulo , Brazil"}]},{"ORCID":"http:\/\/orcid.org\/0000-0002-3462-7288","authenticated-orcid":false,"given":"Lieve","family":"Van Hoovels","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , OLV Hospital , Aalst , Belgium"},{"name":"Department of Microbiology, Immunology and Transplantation , KU Leuven , Leuven , Belgium"}]},{"given":"Maria","family":"Infantino","sequence":"additional","affiliation":[{"name":"Immunology and Allergology Laboratory, S. Giovanni di Dio Hospital , Florence , Italy"}]},{"given":"Marvin J.","family":"Fritzler","sequence":"additional","affiliation":[{"name":"Department of Medicine , Cumming School of Medicine, University of Calgary , Calgary , AB , Canada"}]},{"given":"Dimitrios","family":"Bogdanos","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology , Faculty of Medicine, School of Health Sciences, University of Thessaly, University General Hospital of Larissa , Larissa , Greece"}]},{"given":"Ana","family":"Kozmar","sequence":"additional","affiliation":[{"name":"Department of Laboratory Diagnostics , University Hospital Centre Zagreb , Zagreb , Croatia"}]},{"given":"Benoit","family":"Nespola","sequence":"additional","affiliation":[{"name":"Laboratory of Immunology, H\u00f4pitaux Universitaires de Strasbourg , Strasbourg , France"}]},{"given":"Sylvia","family":"Broeders","sequence":"additional","affiliation":[{"name":"Quality of Laboratories, Sciensano , Ixelles , Belgium"}]},{"given":"Dina","family":"Patel","sequence":"additional","affiliation":[{"name":"UK NEQAS Immunology, Immunochemistry & Allergy, Sheffield Teaching Hospitals , Sheffield , UK"}]},{"given":"Manfred","family":"Herold","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine II, Rheumatology Laboratory , Medical University of Innsbruck , Innsbruck , Austria"}]},{"given":"Bing","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Renji Hospital, School of Medicine, Shanghai Jiao Tong University , Shanghai , P.R. China"}]},{"given":"Eric Y.T.","family":"Chan","sequence":"additional","affiliation":[{"name":"Department of Pathology , Queen Mary Hospital , Hong Kong , P.R. China"}]},{"given":"Raivo","family":"Uibo","sequence":"additional","affiliation":[{"name":"Department of Immunology , Medical Faculty, University of Tartu , Tartu , Estonia"}]},{"given":"Anna-Maija","family":"Haapala","sequence":"additional","affiliation":[{"name":"Department of Immunology , Fimlab Laboratories , Tampere , Finland"}]},{"given":"Lucile","family":"Musset","sequence":"additional","affiliation":[{"name":"Department of Immunology , Assistance Publique-H\u00f4pitaux de Paris, Groupe Hospitalier Piti\u00e9-Salp\u00eatri\u00e8re , Paris , France"}]},{"given":"Ulrich","family":"Sack","sequence":"additional","affiliation":[{"name":"Medical Faculty, Leipzig University , Leipzig , Germany"}]},{"given":"Gabor","family":"Nagy","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Faculty of Medicine, University of Debrecen , Debrecen , Hungary"}]},{"given":"Tatjana","family":"Sundic","sequence":"additional","affiliation":[{"name":"Department of Immunology and Transfusion Medicine , Haugesund Hospital, Helse Fonna , Haugesund , Norway"}]},{"given":"Katarzyna","family":"Fischer","sequence":"additional","affiliation":[{"name":"Individual Laboratory for Rheumatologic Diagnostics, Pomeranian Medical University in Szczecin , Szczecin , Poland"}]},{"given":"Maria-Jos\u00e9","family":"Rego de Sousa","sequence":"additional","affiliation":[{"name":"Immunopathology and Autoimmunity Department , Centro de Medicina Laboratorial Germano de Sousa , Lisbon , Portugal"}]},{"given":"Maria Luisa","family":"Vargas","sequence":"additional","affiliation":[{"name":"Immunology, Hospital Universitario de Badajoz , Badajoz , Spain"}]},{"given":"Catharina","family":"Eriksson","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology Section\u00a0of\u00a0Infection and Immunology , Ume\u00e5 University , Ume\u00e5 , Sweden"}]},{"given":"Ingmar","family":"Heijnen","sequence":"additional","affiliation":[{"name":"Immunology, Laboratory Medicine, University Hospital Basel , Basel , Switzerland"}]},{"given":"Ignacio","family":"Garc\u00eda-De La Torre","sequence":"additional","affiliation":[{"name":"Department of Immunology and Rheumatology , Hospital General de Occidente, Universidad de Guadalajara , Guadalajara , Mexico"}]},{"given":"Orlando Gabriel","family":"Carballo","sequence":"additional","affiliation":[{"name":"Laboratory of Immunology , Hospital Carlos G. Durand , Buenos Aires , Argentina"},{"name":"Department of Microbiology and Immunology , Instituto Universitario, Hospital Italiano de Buenos Aires , Buenos Aires , Argentina"}]},{"given":"Minoru","family":"Satoh","sequence":"additional","affiliation":[{"name":"Department of Human, Information and Life Sciences , University of Occupational and Environmental Health , Kitakyushu , Japan"},{"name":"Department of Medicine , Kitakyushu Yahata-Higashi Hospital , Kitakyushu , Japan"}]},{"given":"Kyeong-Hee","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Dong-A University College of Medicine , Busan , Republic of Korea"}]},{"given":"Edward K.L.","family":"Chan","sequence":"additional","affiliation":[{"name":"Department of Oral Biology , University of Florida , Gainesville , FL , USA"}]},{"ORCID":"http:\/\/orcid.org\/0000-0003-4007-6985","authenticated-orcid":false,"given":"Jan","family":"Damoiseaux","sequence":"additional","affiliation":[{"name":"Central Diagnostic Laboratory , Maastricht University Medical Center , Maastricht , The Netherlands"}]},{"given":"Marcos","family":"Lopez-Hoyos","sequence":"additional","affiliation":[{"name":"Immunology Service , University Hospital Marques de Valdecilla-IDIVAL, University of Cantabria , Santander , Spain"}]},{"given":"Xavier","family":"Bossuyt","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Immunology and Transplantation , KU Leuven , Leuven , Belgium"},{"name":"Department of Laboratory Medicine , University Hospital Leuven , Leuven , Belgium"}]}],"member":"374","published-online":{"date-parts":[[2023,3,29]]},"reference":[{"key":"2024012310382636134_j_cclm-2023-0209_ref_001","doi-asserted-by":"crossref","unstructured":"Bossuyt, X, De Langhe, E, Borghi, MO, Meroni, PL. 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