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Algorithm for antinuclear antibodies in subjects with clinical suspicion of autoimmune diseases
L. Naranjo1, O. Shovman2, D. Pérez3, M. Infantino4, O. Cabrera-Marante5, F. Lozano6, B. Gilburd7, M. Manfredi8, M. Serrano9, L. Morillas10, Y. Shoenfeld11, A. Serrano12
- Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain, and Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
- Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain, and Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
- Immunology and Allergy Laboratory, San Giovanni di Dio Hospital, Azienda USL Toscana Centro, Firenze, Italy.
- Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Department of Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
- Immunology and Allergy Laboratory, San Giovanni di Dio Hospital, Azienda USL Toscana Centro, Firenze, Italy.
- Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Department of Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.
- Department of Immunology, Hospital Universitario 12 de Octubre, Madrid, Spain. aserrano@h12o.es
CER12384
2020 Vol.38, N°4
PI 0633, PF 0639
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PMID: 31694754 [PubMed]
Received: 02/05/2019
Accepted : 06/08/2019
In Press: 17/10/2019
Published: 28/07/2020
Abstract
OBJECTIVES:
Antinuclear antibodies (ANA) are fundamental in the diagnosis of systemic autoimmune rheumatic diseases (SARDs). Different assays for ANA screening are available, such as indirect immunofluorescence (IIF) on HEp-2 cells and Multiplex fluorescent immunoassay (MFI). This study aimed to clarify the importance of ANA detected only by IIF in the future development of SARDs and to recommend a laboratory algorithm that integrates the available diagnostic approaches to optimise the diagnosis of ANA IIF+MFI- subjects.
METHODS:
A total of 9,291 subjects with clinical suspicion of SARDs were evaluated for ANA by IIF and MFI. One hundred and ninety-eight subjects (2.1%) were ANA IIF+MFI-, who were followed up for 2 years. ANA were evaluated using IIF on HEp-2 cells and MFI on the BioPlex 2200.
RESULTS:
The ANA IIF+MFI- cohort included 106 subjects with SARDs, 26 subject with other autoimmune diseases (not-SARDs) and 66 subjects with minor symptoms or ANA requested in check-ups. Only 94 subjects underwent re-evaluation. After a 2-year follow-up, most re-evaluated subjects (51 patients) became ANA negative for both assays (mainly rheumatoid arthritis, polymyalgia and inflammatory bowel disease patients) and 35 subjects remained ANA IIF+MFI- (principally systemic sclerosis and systemic lupus erythematosus patients). A new algorithm for ANA evaluation was suggested.
CONCLUSIONS:
According to the proposed algorithm, ANA IIF+MFI- subjects should be screened by an alternative solid-phase assay such as line-immunoassay or ELISA.