 |
|
|
 |
Measurement of Antinuclear Antibodies by Multiplex Immunoassay: A Prospective, Multicenter Clinical Evaluation
KEVIN G. MODER, MARK H. WENER, MICHAEL H. WEISMAN, MARIKO L. ISHIMORI, DANIEL J. WALLACE, DAVID L. BUCKERIDGE, and HENRY A. HOMBURGER ABSTRACT. Objective. We conducted a prospective, multicenter evaluation of autoantibody testing by multiplex immunoassay in patients with known or suspected connective tissue diseases (CTD). We evaluated agreement between multiplex immunoassay and enzyme immunoassay (EIA) and assessed the diagnostic utility of autoantibody profiles. Methods. Samples from 908 patients with suspected CTD seen in rheumatology clinics were collected prospectively at 3 tertiary care centers. Diagnoses were established according to recognized classification criteria. Tests for autoantibodies were obtained by multiplex immunoassay and by EIA. The results of the multiplex immunoassay were analyzed using a previously validated interpretative algorithm, MDSS (Medical Decision Support Software), that suggests possible disease associations based on the pattern of results for the autoantibodies. Results. The median patient age was 49.7 years; 83% were female. The most common diagnoses were rheumatoid arthritis in 352 patients and systemic lupus erythematosus (SLE) in 332 patients. Agreement between multiplex and EIA testing ranged from a high of 99% (95% CI 98% to 100%) for Jo-1 to a low of 79% (95% CI 76% to 82%) for antinuclear antibodies. The MDSS algorithm suggested an appropriate disease association in 75% to 100% of patients with SLE. The results varied depending on the disease and the autoantibodies present. Conclusion. These results suggest that patterns of autoantibodies detected by multiplex immunoassay testing, when analyzed by an interpretative algorithm, are useful in the evaluation of patients with CTD in situations of high disease prevalence. Further testing is necessary to determine its utility in settings of low disease prevalence. (First Release April 1 2007; J Rheumatol 2007;34:978–86) Key Indexing Terms:
CONNECTIVE TISSUE DISEASE From the Department of Rheumatology, Mayo College of Medicine; Department of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota; Department of Rheumatology, University of Washington, Seattle, Washington; Division of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, California, USA; and Department of Biostatistics, McGill University, Montreal, Quebec, Canada. Supported by a grant from Bio-Rad Laboratories, Hercules, California, USA. K.G. Moder, MD, Associate Professor, Department of Rheumatology, Mayo College of Medicine; M.H. Wener, MD, Professor, Department of Laboratory Medicine, University of Washington; M.H. Weisman, MD, Director, Division of Rheumatology; M.L. Ishimori, MD, Assistant Clinical Professor; D.J. Wallace, MD, Clinical Professor of Medicine, Department of Rheumatology, Cedars-Sinai Medical Center; D.L. Buckeridge, MD, PhD, Department of Epidemiology, Biostatistics, and Occupational Health, McGill University; H.A. Homburger, MD, Director, Immunology Antibody Laboratory, Mayo Clinic. Address reprint requests to Dr. K.G. Moder, Mayo Clinic, 200 First Avenue SW, Rochester, MN 55905, USA. E-mail: vreeman.karen@mayo.edu Accepted for publication January 5, 2007.
|
