High Titer ANA Not Necessarily a Valid Criterion for Lupus – Proposal of a Modification to the Criteria for Classification of SLE

Luis E C Andrade¹, Jan Damoiseaux², Minoru Satoh³, Edward K.L. Chan⁴, Mônica Prado⁵, Henrique Mariz⁶, Renan Agustinelli⁷ and Alessandra Dellavance⁸, ¹Pediatric Rheumatology Unit, Universidade Federal de São Paulo, São Paulo, Brazil, ²Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, Netherlands, ³Department of Clinical Nursing, School of Health Sciences, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴Dept of Oral Biology, University of Florida, Gainesville, FL, ⁵Rheumatology, Escola Paulista de Medicina - Universidade Federal de São Paulo, Sao Paulo, Brazil, ⁶Internal Medicine, Hospital das Clínicas - UFPE, Recife, Brazil, ⁷Rheumatology Division, Escola Paulista de Medicina, São Paulo, Brazil, ⁸Research and Development Department, Fleury Medicine and Health Laboratories, São Paulo, Brazil

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ANA, Anti-DNA, autoantigens and diagnostic criteria

Session Information

Date: Sunday, November 13, 2016

Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment II: Clinical Trial Design

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: A positive ANA test is one of ACR Revised Criteria for Classification of SLE, as well as the SLICC classification. The ANA test provides a direct initial assessment of autoantibody response in candidate patients of systemic autoimmune rheumatic diseases (SARD). As a follow-up to the International Consensus on ANA Patterns (ICAP) initiative (ANApatterns.org), which aims to promote harmonization of ANA pattern nomenclature and provides guidelines for ANA interpretation, thereby optimizing usage in patient care, the relevance of each ANA pattern is being re-evaluated. An important observation is that, while the Homogeneous (AC-1) and Coarse Speckled nuclear (AC-5) patterns are linked to autoantibodies strongly associated with SARD, the Dense Fine Speckled (DFS) nuclear pattern (AC-2) virtually rules out a SARD diagnosis. A clear-cut DFS pattern is usually present when anti-DFS70 is the only predominant autoantibody. DFS is the most common pattern in high titer ANA+, apparently healthy, individuals. Although DFS has been reported in a wide variety of chronic inflammatory diseases, it is not associated with SARD even when present at very high titer.

Methods: ANA test at 1/80 screening dilution was performed in 269 sequentially selected patients with SLE diagnosis, 918 healthy individuals, and 558 patients with non-SARD conditions (arterial hypertension, diabetes mellitus, dyslipidemia, various cancers, psychiatric diseases, and HCV/HIV infection). ANA interpretation was the consensus of 3 independent readers using 2 HEp-2 cell slide brands at 400x mag. Conversely, sequentially selected individuals presenting >1/640 titer DFS ANA pattern in a large clinical laboratory within a 2-year period had the diagnosis assessed by interview with the respective physician.

Results: Among 269 consecutive SLE patients, 96.3% had a positive ANA with the following principal nuclear patterns: homogeneous (29.3%), coarse speckled (14.7%), fine speckled (40.1%). One patient (0.3%) had the DFS pattern and the reactivity to DFS70 confirmed by ELISA. Conversely, among 118 ANA+ healthy individuals and 102 ANA+ patients with miscellaneous non-SARD conditions, 33.1 and 16.7% presented the DFS pattern, respectively. In addition, the 327 consecutive high-titer DFS individuals presented mostly non-SARD conditions or non-specific clinical presentation. Only 7 had possibly SARD-related presentations: 1 anti-phospholipid syndrome, 1 “possible” SLE (polyarthritis, arthritis, chronic urticaria), 1 WG, 1 DLE, 1 primary biliary cirrhosis, and 1 RA.

Conclusion: Well-defined anti-DFS ANA, confirmed by antigen-specific reflex testing, should not be considered a criterion for SLE – either in the ACR or SLICC classification criteria.

Disclosure: L. E. C. Andrade, None; J. Damoiseaux, None; M. Satoh, None; E. K. L. Chan, None; M. Prado, None; H. Mariz, None; R. Agustinelli, None; A. Dellavance, None.

To cite this abstract in AMA style:

Andrade LEC, Damoiseaux J, Satoh M, Chan EKL, Prado M, Mariz H, Agustinelli R, Dellavance A. High Titer ANA Not Necessarily a Valid Criterion for Lupus – Proposal of a Modification to the Criteria for Classification of SLE [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/high-titer-ana-not-necessarily-a-valid-criterion-for-lupus-proposal-of-a-modification-to-the-criteria-for-classification-of-sle/. Accessed .

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