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Abstract Number: 774

Anti-Nuclear Antibodies Have High Sensitivity for Systemic Lupus Erythematosus: Results of a Systematic Literature Review and Meta-Regression of Diagnostic Data

Nicolai Leuchten1, Ralph Brinks2, Annika Hoyer3, Monika Schoels4, Martin Aringer1, Sindhu R. Johnson5, David I. Daikh6, Thomas Dorner7, George Bertsias8 and on behalf of the SLE Classification Criteria Steering Committee, 1Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany, 2Hiller Center for Research in Rheumatology, Duesseldorf, Germany, 3Institute for Biometry and Epidemiology, German Diabetes Center, Duesseldorf, Germany, 42nd Department of Medicine, Hietzing Hospital, Vienna, Austria, 5Dept of Rheumatology, Toronto Western and Mt. Sinai Hospitals, University of Toronto, Toronto, ON, Canada, 6Rheumatology, UCSF/VA Medical Center, San Francisco, CA, 7Charité University Medicine Berlin, Berlin, Germany, 8Rheumatology, Clinical Immunology, and Allergy, University of Crete, Heraklion, Greece

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: ANA, classification criteria and systemic lupus erythematosus (SLE)

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Session Information

Date: Sunday, November 8, 2015

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: EULAR and ACR have jointly funded a project to improve existing SLE classification criteria, aiming at earlier and more accurate classification of the disease. This abstract reports on an early phase of that project. 

ANA constitute the immunological hallmark of SLE, and ANA testing is widely used for SLE diagnosis based on its reportedly high sensitivity. Although indirect immunofluorescence on Hep-2 cells (IIF-Hep2) is considered the gold standard of ANA testing (1), the performance of different ANA titers and the possibility of including positive ANA as an entry criterion for the classification of SLE have not been systematically evaluated. We therefore reviewed the literature on the performance of IIF-Hep2 ANA testing for the classification/diagnosis of SLE. 

Methods: A systematic literature search was conducted in MEDLINE, EMBASE and Cochrane trial database for articles published between January 1990 and March 2014. The research question was structured according to PICO (Population, Intervention, Comparator, Outcome) format rules, and PRISMA recommendations were followed where appropriate. Meta-regression analysis for diagnostic tests was performed using the ANA titer as independent variable and sensitivity and specificity as dependent variables.

Results: A total of 3919 publications were screened in abstract and title and 623 articles were evaluated in full-text. Of these, 61 matched the eligibility criteria and were included in the analysis. The included studies comprised 10,309 SLE patients in total, of whom 9,797 (95.0%) were reported to be ANA positive at various titers. For ANA at titers of 1:40, 1:80 and 1:160, meta-regression gave sensitivity values of 98.6% (95% confidence interval [CI] 97.7-99.1%), 97.9% (CI 96.9-98.6%) and 95.9% (CI 93.9–97.3%), respectively. The corresponding specificities were 72.5% (CI 63.8-79.7%), 79.6% (CI 72.4-85.3%) and 89.6% (CI 84.8-93.0%), respectively.

Conclusion: The results of this systematic literature search and meta-regression confirm the high sensitivity of a positive ANA test for SLE. However, a small subgroup of true ANA negative SLE patients suggests that positive ANA should not be an absolute entry criterion for classifying SLE, but that it might function well in a combined entry criterion, such as positive ANA and/or low complements.

Reference: (1)Agmon-Levin et al, Ann Rheum Dis 2014; 73: 17ff


Disclosure: N. Leuchten, None; R. Brinks, None; A. Hoyer, None; M. Schoels, None; M. Aringer, None; S. R. Johnson, None; D. I. Daikh, None; T. Dorner, None; G. Bertsias, None.

To cite this abstract in AMA style:

Leuchten N, Brinks R, Hoyer A, Schoels M, Aringer M, Johnson SR, Daikh DI, Dorner T, Bertsias G. Anti-Nuclear Antibodies Have High Sensitivity for Systemic Lupus Erythematosus: Results of a Systematic Literature Review and Meta-Regression of Diagnostic Data [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/anti-nuclear-antibodies-have-high-sensitivity-for-systemic-lupus-erythematosus-results-of-a-systematic-literature-review-and-meta-regression-of-diagnostic-data/. Accessed .
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