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. 2023 Mar 29;61(7):1167-1198.
doi: 10.1515/cclm-2023-0209. Print 2023 Jun 27.

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

Carolien Bonroy  1   2 , Martine Vercammen  3   4 , Walter Fierz  5 , Luis E C Andrade  6   7 , Lieve Van Hoovels  8   9 , Maria Infantino  10 , Marvin J Fritzler  11 , Dimitrios Bogdanos  12 , Ana Kozmar  13 , Benoit Nespola  14 , Sylvia Broeders  15 , Dina Patel  16 , Manfred Herold  17 , Bing Zheng  18 , Eric Y T Chan  19 , Raivo Uibo  20 , Anna-Maija Haapala  21 , Lucile Musset  22 , Ulrich Sack  23 , Gabor Nagy  24 , Tatjana Sundic  25 , Katarzyna Fischer  26 , Maria-José Rego de Sousa  27 , Maria Luisa Vargas  28 , Catharina Eriksson  29 , Ingmar Heijnen  30 , Ignacio García-De La Torre  31 , Orlando Gabriel Carballo  32   33 , Minoru Satoh  34   35 , Kyeong-Hee Kim  36 , Edward K L Chan  37 , Jan Damoiseaux  38 , Marcos Lopez-Hoyos  39 , Xavier Bossuyt  9   40 ; European Federation of Laboratory Medicine (EFLM) Working Group “Autoimmunity Testing,” the European Autoimmune Standardization Initiative (EASI) and International Consensus on Antinuclear Antibody Patterns (ICAP)
Affiliations
Free article

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

Carolien Bonroy et al. Clin Chem Lab Med. .
Free article

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.

Keywords: HEp-2 indirect immunofluorescence; antinuclear antibodies; recommendations.

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