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

Fecha de publicación: Fecha Ahead of Print:

Autores de IDIVAL

  • Marcos López Hoyos

    Autor

Autores ajenos al IDIVAL

  • Bonroy C
  • Vercammen M
  • Fierz W
  • Andrade LEC
  • Van Hoovels L
  • Infantino M
  • Fritzler MJ
  • Bogdanos D
  • Kozmar A
  • Nespola B
  • Broeders S
  • Patel D
  • Herold M
  • Zheng B
  • Chan EYT
  • Uibo R
  • Haapala AM
  • Musset L
  • Sack U
  • Nagy G
  • Sundic T
  • Fischer K
  • Rego de Sousa MJ
  • Vargas ML
  • Eriksson C
  • Heijnen I
  • García-De La Torre I
  • Carballo OG
  • Satoh M
  • Kim KH
  • Chan EKL
  • Damoiseaux J
  • Bossuyt X
  • European Federation of Laboratory Medicine (EFLM) Working Group “Autoimmunity T

Unidades

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.

© 2023 Walter de Gruyter GmbH, Berlin/Boston.

Datos de la publicación

ISSN/ISSNe:
1434-6621, 1437-4331

CLINICAL CHEMISTRY AND LABORATORY MEDICINE  WALTER DE GRUYTER GMBH

Tipo:
Article
Páginas:
1167-1198
PubMed:
36989417
Factor de Impacto:
0,000 SCImago

Citas Recibidas en Web of Science: 34

Documentos

  • No hay documentos

Métricas

Filiaciones mostrar / ocultar

Keywords

  • HEp-2 indirect immunofluorescence; antinuclear antibodies; recommendations

Cita

Compartir