title: Evaluation of diagnostic tests for antinuclear antibodies in rheumatological practice.
abstract: To investigate and compare the accuracy and usefulness of diagnostic tests for antinuclear antibodies (ANA) a cross-sectional study of sera derived from patients admitted to the Department of Rheumatology was tested for the presence of ANA using either indirect immunofluorescence on HEp-2 cells, indirect immunoperoxidase techniques on HEp-2 cells and mouse kidney, or two commercial enzyme-linked immunosorbent assays (ELISA). The diagnostic sensitivity and predictive values of the tests were calculated and compared. The accuracy of tests was compared using receiver-operating characteristics (ROC) methodology. All ANA-positive sera were further analysed for the presence of antibodies against extractable nuclear antigens (anti-ENA) and anti-DNA. A moderate to good agreement was found between tests, with kappa ranging from 0.469 to 0.659. Highest sensitivity for systemic lupus erythematosus (SLE; 93.3%) and primary Sjögren's syndrome (SS; 70%) was found using immunofluorescence on HEp-2 cells. Immunofluorescence on HEp-2 cells performed statistically better than the other tests in predicting SLE but not SS. All tests except mouse kidney showed good and comparable performance in detecting sera with anti-ENA and anti-DNA. At the given cut-off values indirect immunofluorescence on HEp-2 cells performed best. All assays except mouse kidney showed performance characteristics sufficient for use in routine analysis of ANA.
authors.affiliation: Department of Microbiology and Immunology, The Gade Institute, Haukeland University Hospital, Bergen, Norway. elling.ulvestad@haukeland.no
authors.forename: E
authors.initials: E
authors.lastname: Ulvestad
authors.forename: A
authors.initials: A
authors.lastname: Kanestrøm
authors.forename: T M
authors.initials: TM
authors.lastname: Madland
authors.forename: E
authors.initials: E
authors.lastname: Thomassen
authors.forename: H J
authors.initials: HJ
authors.lastname: Haga
authors.forename: S E
authors.initials: SE
authors.lastname: Vollset
mesh_terms: D000818:Animals; D000974:Antibodies, Antinuclear / Q000097:blood*; D000918:Antibody Specificity; D034961:Antigens, Nuclear; D001324:Autoantigens / Q000276:immunology; D001327:Autoimmune Diseases / Q000097:blood / Q000276:immunology*; D002294:Carcinoma, Squamous Cell / Q000473:pathology; D002460:Cell Line; D003240:Connective Tissue Diseases / Q000097:blood / Q000276:immunology*; D003430:Cross-Sectional Studies; D004247:DNA / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D019084:Fluorescent Antibody Technique, Indirect; D006801:Humans; D007124:Immunoenzyme Techniques; D007668:Kidney; D007822:Laryngeal Neoplasms / Q000473:pathology; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000276:immunology; D051379:Mice; D009687:Nuclear Proteins / Q000276:immunology; D012372:ROC Curve; D015203:Reproducibility of Results; D012219:Rheumatology / Q000379:methods*; D012680:Sensitivity and Specificity; D012859:Sjogren's Syndrome / Q000097:blood / Q000276:immunology; D014407:Tumor Cells, Cultured
chemical_list: D000974:Antibodies, Antinuclear; D034961:Antigens, Nuclear; D001324:Autoantigens; D009687:Nuclear Proteins; D004247:DNA