Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAPEFLM Paper-Reference-Cited by-同舟云学术

Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAPEFLM Paper

Published:2024-05-19 Issue:2 Volume:60 Page:38-83
ISSN:0867-4043
Container-title:Diagnostyka Laboratoryjna
language:
Short-container-title:Diagn Lab.

Author:

Bonroy Carolien¹,Vercammen Martine²,Fierz Walter³,Andrade Luis E.C.⁴,Van Hoovels Lieve⁵,Infantino Maria⁶,Fritzler Marvin J.⁷,Bogdanos Dimitrios⁸,Kozmar Ana⁹,Nespola Benoit¹⁰,Broeders Sylvia¹¹,Patel Dina¹²,Herold Manfred¹³,Zheng Bing¹⁴,Chan Eric Y.T.¹⁵,Uibo Raivo¹⁶,Haapala Anna-Maija¹⁷,Musset Lucile¹⁸,Sack Ulrich¹⁹,Nagy Gabor²⁰,Sundic Tatjana²¹,Fischer Katarzyna²²,Rego de Sousa Maria-José²³,Vargas Maria Luisa²⁴,Eriksson Catharina²⁵,Heijnen Ingmar²⁶,García-De La Torre Ignacio²⁷,Carballo Orlando Gabriel²⁸,Satoh Minoru²⁹,Kim Kyeong-Hee³⁰,Chan Edward K.L.³¹,Damoiseaux Jan³²,Lopez-Hoyos Marcos³³,Bossuyt Xavier³⁴

Affiliation:

1. Department of Diagnostic Sciences, Ghent University, Ghent, Belgium, Department of Laboratory Medicine, University Hospital Ghent, Ghent, Belgium

2. Department of Laboratory Medicine, AZ Sint-Jan, Brugge, Belgium, Research Group REIM, Vrije Universiteit Brussel, Brussels, Belgium

3. Schweizerischer Verband der Diagnostikindustrie (SVDI-ASID), Bern, Switzerland

4. Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de Sao Paulo, Sao Paulo, Brazil, Immunology Division, Fleury Medicine and Health Laboratories, Sao Paulo, Brazil

5. Department of Laboratory Medicine, OLV Hospital, Aalst, Belgium, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium

6. Immunology and Allergology Laboratory, S. Giovanni di Dio Hospital, Florence, Italy

7. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada

8. Department of Rheumatology and Clinical Immunology, Faculty of Medicine, School of Health Sciences, University of Thessaly, University General Hospital of Larissa, Larissa, Greece

9. Department of Laboratory Diagnostics, University Hospital Centre Zagreb, Zagreb, Croatia

10. Laboratory of Immunology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

11. Quality of Laboratories, Sciensano, Ixelles, Belgium

12. UK NEQAS Immunology, Immunochemistry & Allergy, Sheffield Teaching Hospitals, Sheffield, UK

13. Department of Internal Medicine II, Rheumatology Laboratory, Medical University of Innsbruck, Innsbruck, Austria

14. Department of Laboratory Medicine, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China

15. Department of Pathology, Queen Mary Hospital, Hong Kong, P.R. China

16. Department of Immunology, Medical Faculty, University of Tartu, Tartu, Estonia

17. Department of Immunology, Fimlab Laboratories, Tampere, Finland

18. Department of Immunology, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Paris, France

19. Medical Faculty, Leipzig University, Leipzig, Germany

20. Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary

21. Department of Immunology and Transfusion Medicine, Haugesund Hospital, Helse Fonna, Haugesund, Norway

22. Individual Laboratory for Rheumatologic Diagnostics, Pomeranian Medical University in Szczecin, Szczecin, Poland

23. Immunopathology and Autoimmunity Department, Centro de Medicina Laboratorial Germano de Sousa, Lisbon, Portugal

24. Immunology, Hospital Universitario de Badajoz, Badajoz, Spain

25. Department of Clinical Microbiology Section of Infection and Immunology, Umeå University, Umeå, Sweden

26. Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland

27. Department of Immunology and Rheumatology, Hospital General de Occidente, Universidad de Guadalajara, Guadalajara, Mexico

28. Laboratory of Immunology, Hospital Carlos G. Durand, Buenos Aires, Argentina; and Department of Microbiology and Immunology, Instituto Universitario, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

29. Department of Human, Information and Life Sciences, University of Occupational and Environmental Health, Kitakyushu, Japan, Department of Medicine, Kitakyushu Yahata-Higashi Hospital, Kitakyushu, Japan

30. Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Republic of Korea

31. Department of Oral Biology, University of Florida, Gainesville, FL, USA

32. Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, The Netherlands

33. Immunology Service, University Hospital Marques de Valdecilla-IDIVAL, University of Cantabria, Santander, Spain

34. Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium, Department of Laboratory Medicine, University Hospital Leuven, Leuven, Belgium

Abstract

Aim: 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.

Publisher

Index Copernicus

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