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Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP

Abstract: Objectives: 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). Methods: 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 ?Autoimmunity Testing?; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP). Results: 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. Conclusions: These recommendations are an important step to achieve high quality ANA testing.

 Fuente: Clinical Chemistry and Laboratory Medicine, 2023, 61(7), 1167-1198

 Publisher: Walter de Gruyter

 Year of publication: 2023

 No. of pages: 32

 Publication type: Article

 DOI: 10.1515/cclm-2023-0209

 ISSN: 1434-6621,1437-4331

 Publication Url: https://doi.org/10.1515/cclm-2023-0209

Authorship

BONROY, CAROLIEN

VERCAMMEN, MARTINE

FIERZ, WALTER

ANDRADE, LUIS E.C.

VAN HOOVELS, LIEVE

INFANTINO, MARIA

FRITZLER, MARVIN J.

BOGDANOS, DIMITRIOS

KOZMAR, ANA

NESPOLA, BENOIT

BROEDERS, SYLVIA

PATEL, DINA

HEROLD, MANFRED

ZHENG, BING

CHAN, ERIC Y.T.

UIBO, RAIVO

HAAPALA, ANNA-MAIJA

MUSSET, LUCILE

SACK, ULRICH