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

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

Published:2023-03-29 Issue:7 Volume:61 Page:1167-1198
ISSN:1434-6621
Container-title:Clinical Chemistry and Laboratory Medicine (CCLM)
language:en
Short-container-title:

Author:

Bonroy Carolien¹²,Vercammen Martine³⁴,Fierz Walter⁵,Andrade Luis E.C.⁶⁷^ORCID,Van Hoovels Lieve⁸⁹^ORCID,Infantino Maria¹⁰,Fritzler Marvin J.¹¹,Bogdanos Dimitrios¹²,Kozmar Ana¹³,Nespola Benoit¹⁴,Broeders Sylvia¹⁵,Patel Dina¹⁶,Herold Manfred¹⁷,Zheng Bing¹⁸,Chan Eric Y.T.¹⁹,Uibo Raivo²⁰,Haapala Anna-Maija²¹,Musset Lucile²²,Sack Ulrich²³,Nagy Gabor²⁴,Sundic Tatjana²⁵,Fischer Katarzyna²⁶,Rego de Sousa Maria-José²⁷,Vargas Maria Luisa²⁸,Eriksson Catharina²⁹,Heijnen Ingmar³⁰,García-De La Torre Ignacio³¹,Carballo Orlando Gabriel³²³³,Satoh Minoru³⁴³⁵,Kim Kyeong-Hee³⁶,Chan Edward K.L.³⁷,Damoiseaux Jan³⁸^ORCID,Lopez-Hoyos Marcos³⁹,Bossuyt Xavier⁹⁴⁰

Affiliation:

1. Department of Diagnostic Sciences , Ghent University , Ghent , Belgium

2. Department of Laboratory Medicine , University Hospital Ghent , Ghent , Belgium

3. Department of Laboratory Medicine, AZ Sint-Jan , Brugge , Belgium

4. Research Group REIM, Vrije Universiteit Brussel , Brussels , Belgium

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

6. Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de Sao Paulo , Sao Paulo , Brazil

7. Immunology Division, Fleury Medicine and Health Laboratories , Sao Paulo , Brazil

8. Department of Laboratory Medicine , OLV Hospital , Aalst , Belgium

9. Department of Microbiology, Immunology and Transplantation , KU Leuven , Leuven , Belgium

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

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

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

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

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

15. Quality of Laboratories, Sciensano , Ixelles , Belgium

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

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

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

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

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

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

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

23. Medical Faculty, Leipzig University , Leipzig , Germany

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

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

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

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

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

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

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

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

32. Laboratory of Immunology , Hospital Carlos G. Durand , Buenos Aires , Argentina

33. Department of Microbiology and Immunology , Instituto Universitario, Hospital Italiano de Buenos Aires , Buenos Aires , Argentina

34. Department of Human, Information and Life Sciences , University of Occupational and Environmental Health , Kitakyushu , Japan

35. Department of Medicine , Kitakyushu Yahata-Higashi Hospital , Kitakyushu , Japan

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

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

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

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

40. Department of Laboratory Medicine , University Hospital Leuven , Leuven , Belgium

Abstract

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.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Link

https://www.degruyter.com/document/doi/10.1515/cclm-2023-0209/pdf

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