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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 Fede
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