Objective: We evaluated the diagnostic and analytical performance of the Coupled Particle Light Scattering technology applied to the detection of anti-topoisomerase I (anti-Scl70) and anti-CENP-B autoantibodies.
Methods: The Scl70 antigen was obtained by recombinant DNA procedures using a prokaryotic expression system; CENP-B was a Baculovirus-expressed recombinant protein. Anti-centromere and anti-Scl70 antibodies were assayed in serum samples from 288 patients, of whom 123 had systemic sclerosis/scleroderma and 165 constituted the control groups (including patients with other connective tissue diseases, viral infections, Lyme disease, and healthy subjects).
Results: The sensitivity was 98.8% (confidence interval, 96-101%) for anti-Scl70 and 100% (99.6-100%) for anti-CENP-B; the specificity was 99.0% (98-100%) and 100% (99.9-100%) for anti-Scl70 and anti-CENP-B, respectively. The intra-assay coefficient variations (CV) ranged from 3.8 to 9.2% for anti-Scl70, and from 2.8 to 8.0% for anti-CENP-B. Inter-assay CVs were 8.1 to 12.0% for anti-Scl70, and 4.7 to 10.5% for anti-CENP-B. In 3 patients, coexpression of both antibodies was observed.
Conclusion: The results of this study demonstrate that the light scattering technology is also applicable to the detection of autoantibodies to intracellular antigens for the diagnosis of autoimmune rheumatic diseases.
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