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Journal of Immunology Research
Volume 2015, Article ID 902821, 8 pages
http://dx.doi.org/10.1155/2015/902821
Research Article

Clinical Comparison of QUANTA Flash dsDNA Chemiluminescent Immunoassay with Four Current Assays for the Detection of Anti-dsDNA Autoantibodies

1Immunology and Allergology Laboratory Unit, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143 Florence, Italy
2Inova Diagnostics, Inc., San Diego, CA 92131, USA
3UO Reumatologia, Ospedale S. Giovanni di Dio, 3055 69321 Firenze, Italy
4UOC Medicina Clinica e Reumatologia, Università Campus Bio-Medico, Via Álvaro del Portillo 21, Roma, Italy
5UOC Reumatologia, Ospedale L. Sacco Polo Universitario, Via Giovanni Battista Grassi 74, 20157 Milano, Italy

Received 24 July 2014; Accepted 17 September 2014

Academic Editor: Ghislain Opdenakker

Copyright © 2015 Maria Infantino et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Introduction. The objective of the present study was to compare QUANTA Flash dsDNA, a chemiluminescent immunoassay (CIA) on the BIO-FLASH, a rapid-response chemiluminescent analyzer, to three other anti-dsDNA antibody assays and to Crithidia luciliae indirect immunofluorescence test (CLIFT). Methods. In the first part of the study, 161 samples, 61 from patients suffering from systemic lupus erythematosus (SLE) and 100 from a disease control group, were tested by QUANTA Flash dsDNA CIA, QUANTA Lite dsDNA SC ELISA, BioPlex 2200 multiplex flow immunoassay (MFI), ImmuLisa dsDNA ELISA, and NOVA Lite CLIFT. A second cohort of 69 SLE patients was then tested by QUANTA Flash dsDNA and CLIFT to expand the study. Results. The overall qualitative agreements varied between 77.0% (NOVA Lite CLIFT versus QUANTA Lite) and 89.4% (ImmuLisa versus NOVA Lite CLIFT). The clinical sensitivities for the anti-dsDNA antibody tests varied from 8.2% (NOVA Lite CLIFT) to 54.1% (QUANTA Lite), while the clinical specificities varied from 88.0% (BioPlex 2200) to 100.0% (NOVA Lite CLIFT). Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT. Conclusion. Significant variations among dsDNA methods were observed. QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.