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Clinical and Vaccine Immunology, May 2007, p. 505-509, Vol. 14, No. 5
1071-412X/07/$08.00+0     doi:10.1128/CVI.00034-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Clinical Value of Multiplexed Bead-Based Immunoassays for Detection of Autoantibodies to Nuclear Antigens{triangledown}

Erik Avaniss-Aghajani,* Sophia Berzon, and Arlen Sarkissian

Primex Clinical Laboratories, Inc., 16742 Stagg St. #120, Van Nuys, California 91406

Received 15 January 2007/ Returned for modification 16 February 2007/ Accepted 9 March 2007

The advent of multiplexed bead assays in recent years has introduced a new dimension of testing for complex diseases such as lupus, which can involve multiple autoantibodies. The ability to rapidly identify multiple autoantibodies, with high sensitivity and specificity in an automated fashion, is highly attractive. The aim of this study was to assess the performance and clinical value of multiplexed bead-based (AtheNA Multi-Lyte ANA-II test system) immunoassays both by comparing the results with those achieved by indirect fluorescent-antibody assay (IFA) or conventional enzyme immunoassays (EIAs) and by independent identification of autoantibodies in well-characterized samples. To achieve this goal, 984 samples were tested for seven analytes (SS/A, SS/B, Sm, RNP, Scl-70, double-stranded DNA [dsDNA], and centromere B) in both traditional and bead-based assays. The average concordance for the different analytes was 91%, ranging from 81% (dsDNA) to 97% (centromere B). The average relative specificity and sensitivity for the analytes were also high, 92% and 81%, respectively. An examination of 93 "normal controls" demonstrated a 7% false-positive rate, which was comparable to IFA. Percentages of different autoantibodies found in patients with a variety of disease conditions (34 with calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia; 41 with mixed connective tissue disease; 24 with scleroderma; and 35 with Sjogren's syndrome) were well within the range expected from each group. A scrutiny of results from AtheNA and EIA and Farr results for 185 systemic lupus erythematosus samples revealed comparable results by both methods, with the exception of SS/A and dsDNA, where AtheNA had a higher percentage of SS/A-positive results compared to EIA (51% versus 29%) and a lower percentage of dsDNA-positive results (18% versus 28% at a cutoff of 5 IU/ml).

* Corresponding author. Mailing address: Primex Clinical Laboratories, 16742 Stagg Street #120, Van Nuys, CA 91406. Phone: (310) 383-6059. Fax: (818) 779-1059. E-mail: erik{at}primexlab.com

{triangledown} Published ahead of print on 21 March 2007.

Clinical and Vaccine Immunology, May 2007, p. 505-509, Vol. 14, No. 5
1071-412X/07/$08.00+0     doi:10.1128/CVI.00034-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.





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