International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies
Open accessAbstract
Anti-nuclear antibodies (ANA) are fundamental for the diagnosis of autoimmune diseases, and have been determined by indirect immunofluorescence assay (IIFA) for decades. As the demand for ANA testing increased, alternative techniques were developed challenging the classic IIFA. These alternative platforms differ in their antigen profiles, sensitivity and specificity, raising uncertainties regarding standardisation and interpretation of incongruent results. Therefore, an international group of experts has created recommendations for ANA testing by different methods. Two groups of experts participated in this initiative. The European autoimmunity standardization initiative representing 15 European countries and the International Union of Immunologic Societies/World Health Organization/Arthritis Foundation/Centers for Disease Control and Prevention autoantibody standardising committee. A three-step process followed by a Delphi exercise with closed voting was applied. Twenty-five recommendations for determining ANA (1-13), anti-double stranded DNA antibodies (14-18), specific antibodies (19-23) and validation of methods (24-25) were created. Significant differences between experts were observed regarding recommendations 24-25 (p<0.03). Here, we formulated recommendations for the assessment and interpretation of ANA and associated antibodies. Notably, the roles of IIFA as a reference method, and the importance of defining nuclear and cytoplasmic staining, were emphasised, while the need to incorporate alternative automated methods was acknowledged. Various approaches to overcome discrepancies between methods were suggested of which an improved bench-to-bedside communication is of the utmost importance. These recommendations are based on current knowledge and can enable harmonisation of local algorithms for testing and evaluation of ANA and related autoantibodies. Last but not least, new more appropriate terminologies have been suggested.
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Many studies recommend confirming positive ELISA results using CLIFT or Farr test to ensure improved specificity.
“Therefore, many studies recommend confirming positive ELISA results using CLIFT or rarely Farr test, thus ensuring improved specificity [17,21].”
From Anti-double stranded DNA antibodies: A rational diagnostic approach in limited-resource settings (2022) · cites this paper as [21]
Recommendation 15 (Discrepancy between platforms; page unavailable) advises confirming positive results from lower-specificity alternative anti-dsDNA assays with CLIFT or Farr, which offer high clinical specificity. The paper identifies ELISA as an anti-dsDNA assay, but the recommendation is limited to anti-dsDNA testing; it does not establish that many studies make this recommendation or that Farr confirmation is rare. (LLM, conf=0.85)
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- Authors
- Agmon-Levin, N., Damoiseaux, J., Kallenberg, C., Sack, U., Witte, T., Herold, M., Bossuyt, X., Musset, L., Cervera, R., Plaza-Lopez, A., Dias, C., Sousa, M. J., Radice, A., Eriksson, C., Hultgren, O., Viander, M., Khamashta, M., Regenass, S., Andrade, L. E. C., Wiik, A., Tincani, A., Rönnelid, J., Bloch, D. B., Fritzler, M. J., Chan, E. K. L., Garcia-De La Torre, I., Konstantinov, K. N., Lahita, R., Wilson, M., Vainio, O., Fabien, N., Sinico, R. A., Meroni, P., Shoenfeld, Y., Tervaert, J. C., Hamann, D., Derksen, R., Hooijkaas, H., Klasen, I., Limburg, P., Smeenk, R., van Daele, P., Elvin, K., Dahle, C., Skogh, T., Antonen, J., Haapala, A.-M., Hietarinta, M., Häkkinen, T., Hänninen, A., Jokiranta, S., Karjalainen, A., Laatikainen, A., Leirisalo-Repo, M., Luosujärvi, R., Miettinen, A., Siuro, J., Sved, S., Tuuminen, T., Walle, T., Coelho, F., Santos, M. J., Bogas, M., Ramos, J. P., Faro-Viana, J., Olsson, N. O., Chyderiotis, G., Bach-Nga, Aubert, V., Dahinden, C., Dayer, E., Mascart, F., Tomasi, J.-P., Vercammen, M., Verschueren, P., Houssiau, F., Lauwerys, B., De Keyser, F., Fierz, W., Heijnen, I., Keller, F., Müllner, G., Regenass, S., Roux-Lombard, P., Wirthmüller, U., Gilburde, B., Levi, R., Lipinsky, D., Barak, M., Mahmud, A.-S., Fishel, R., Foguel, M., Shay, K., Csernok, E., Schlüter, B., Becker, B., Mierau, R., Witte, T., Seidel, W., Frank, I., Kromminga, A., Hiepe, F., Conrad, K., Sticherling, M., Steiner, G., Valentyna, C., Alcalá, I., Alsina, M., José, A. M., Carrasco, Á., Fernández, L., Figueredo, M. Á., Gelpí, C., Jiménez, J., Juliá, M. R., López-Hoyos, M., Mozo, L., Muñoz, C., Muñoz, F. J., Palomino, P., Prada, Á., Hernandez, C. R., Roy, G., Ruiz, E., & Vargas, L.
- Affiliations
- Maastricht University Medical Centre (NL)
- University of Groningen (NL)
- Leipzig University (DE)
- Innsbruck Medical University (AT)
- KU Leuven (BE)
- Pitié-Salpêtrière Hospital (FR)
- Hospital Clínic de Barcelona (ES)
- Hospital de São João (PT)
- Hospital Prof. Dr. Fernando Fonseca (PT)
- Azienda Ospedaliera Ospedale San Carlo Borromeo (IT)
- Umeå University (SE)
- Örebro University (SE)
- University of Turku (FI)
- King's College London (GB)
- Statens Serum Institut (DK)
- Uppsala University (SE)
- Harvard University (US)
- University of Calgary (CA)
- University of Florida (US)
- University of New Mexico (US)
- Newark Beth Israel Medical Center (US)
- Louisiana State University (US)
- NordLab (FI)
- Hôpital Lyon Sud (FR)
- Tel Aviv University (IL)
- Corresponding author
- Shoenfeld, Yehuda
- ORCID
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2014-01
- Volume
- 73
- Issue
- 1
- Pages
- 17-23
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2125497658
- Cited by
- 615
- References
- 49
- Citations by year
- 2026: 27 · 2025: 38 · 2024: 41 · 2023: 42 · 2022: 59 · 2021: 56 · 2020: 54 · 2019: 59 · 2018: 55 · 2017: 41 · 2016: 47 · 2015: 45 · 2014: 48 · 2013: 3
- FWCI
- 39.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- RECERCAT (Consorci de Serveis Universitaris de Catalunya) (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (submittedVersion, public-domain)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Pathology and Forensic Medicine › Systemic Sclerosis and Related Diseases
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- antinuclear antibodies, autoantibody detection, indirect immunofluorescence, anti-dsDNA antibodies, autoimmune disease diagnosis, method standardization, method validation, expert recommendations, Delphi consensus, terminology
- MeSH terms
- Allergy and Immunology, Antibodies, Antinuclear, Autoantigens, Humans, Immunologic Tests, Terminology as Topic, Rheumatic Diseases, Rheumatology
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