Abstract
Objectives
Autoantibodies and, specifically antinuclear antibodies (ANA), are the hallmark of systemic autoimmune diseases (AID). In the last decades, there has been great technical development to detect these autoantibodies along with an increased request for this test by clinicians, while the overall pre-test probability has decreased. In this study, we compare the diagnostic performance of three different methods for ANA screening (indirect immunofluorescence [IIF], addressable laser bead immunoassay [ALBIA], and fluorescence enzyme immunoassay [FEIA]).
Methods
Serum samples at baseline visit from 2,997 participants from the Camargo Cohort, a population with an overall low pre-test probability for systemic AID, were analyzed with the three methods. Participants have a minimum follow-up of 10 years and the development of autoimmune diseases was collected from clinical records.
Results
The highest frequency of positive ANA was observed by IIF assay. However, ALBIA showed high sensitivity for AID. Likewise, solid phase assays (SPA) presented higher specificity than IIF for AID. ANA prevalence with any method was significantly higher in females and overall increased with age. Triple positivity for ANA was significantly related to the presence of anti-dsDNA–SSA/Ro60, Ro52, SSB/La, RNP, Scl-70, and centromere–specificities. No association was found for anti-Sm – RNP68, or ribosomal P – specificities. Noteworthy, triple positivity for ANA screening was associated with diagnosis of systemic AID both at baseline visit and follow-up.
Conclusions
ANA detection by IIF may be better when the pre-test probability is high, whereas SPA techniques are more useful in populations with an overall low pre-test probability for systemic AID.
Funding source: Instituto de Salud Carlos III
Award Identifier / Grant number: PI21/00532
Acknowledgments
We acknowledge all the participants of the Camargo Cohort study.
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Research funding: This research has been supported by a grant from Instituto de Salud Carlos III (PI21/00532) that could be co-funded by European Union FEDER funds.
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Author contributions: “Conceptualization, DM-R, JI-V, VMM-T, ML-H, and JLH; methodology, M-T, ML-H, JI-V, JLH; software, DM-R, JI-V, JLH; validation, VMM-T, ML-H, JLH formal analysis, JI-V, VMM-T, JLH; investigation, DM-R, JI-V, VMM-T, JLH; resources, VMM-T, ML-H, JLH; data curation, DM-R, DN, MM-M, EP, AC-B, JMO; writing—original draft preparation, DM-R, JI-V, ML-H, VM-T, JLH; writing—review and editing, ML-H, VMM-T, JLH; visualization, EP, DN, MM-M, ML-H, VMM-T, JLH, AC-B, JMO; supervision, ML-H, VMM-T, JLH; project administration, ML-H, VMM-T, JLH; funding acquisition, ML-H, VMM-T, JLH. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.”
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Competing interests: The authors declare no conflict of interest regarding this paper.
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Informed consent: Informed consent was obtained from all individuals involved in the study.
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Ethical approval: The study has been conducted according to all relevant national regulations, institutional policies, and following the Declaration of Helsinki, and has been approved by the Regional Ethics Committee (CEIm Internal Code: 2020.309).
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-1136).
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