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Role of ANA testing in the classification of patients with systemic lupus erythematosus
  1. David S Pisetsky1,2,
  2. Diane M Spencer1,2,
  3. Brad Rovin3,
  4. Peter E Lipsky4
  1. 1 Medicine, Duke University Medical Center, Durham, North Carolina, USA
  2. 2 Veterans Administration Medical Center, Medical Research Service, Durham, North Carolina, USA
  3. 3 Medicine, Ohio State University, Columbus, Ohio, USA
  4. 4 RILITE Institute, Charlottesville, Virginia, USA
  1. Correspondence to Dr David S Pisetsky, Medicine, Duke University Medical Center, Durham, NC 27705, USA; david.pisetsky{at}

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The recent publication1 2 of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria for the classification for systemic lupus erythematosus (SLE) provides an important reason to continue the dialogue on testing for antinuclear antibodies (ANA) that has appeared in Annals of the Rheumatic Diseases (ARD). Following our article on the variability of immunofluorescence assays (IFA) for testing ANA in SLE,3 the journal published a series of very interesting and informative letters addressing our findings and reporting on other experience in ANA testing.4–12 These letters have been important in alerting the field to the challenges in ANA testing and the variety of assay approaches, including solid phase assays (SPA), that are currently available for determining the serological status of patients.

While our focus was the clinical trial setting, our results are also relevant to the new classification criteria.1 2 These criteria differ from previous classification systems in the positioning of a positive ANA. Whereas a positive ANA represented one criterion in the ACR and Systemic Lupus International Collaborating Clinics criteria,13 14 in the new EULAR/ACR criteria, a positive ANA is necessary for classification; if this criterion is met, other manifestations receive varying numbers of points to determine classification. Such a positioning implies that SLE is always ANA positive, that a negative ANA …

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