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

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.

International multi-center evaluation of a novel chemiluminescence assay for the detection of anti-dsDNA antibodies

“…In terms of clinical performance, the sensitivity in SLE (54.3%) and specificity (89.8%) in the disease controls is similar to previous studies on the CIA and other anti-dsDNA solid phase assays; however, it is important to note that in general there is a high degree of variability reported among the studies for both sensitivity and specificity of the anti-dsDNA methods evaluated. [8][9][10]13,18 In particular, Infantino et al 18 reported a 96.0% specificity (95% CI 90.1-98.9%) and 39.3% sensitivity (95% CI 27.2-52.7%) for the CIA in an Italian cohort, while this study demonstrated lower . Whether the patients have active or inactive disease; .…”

“…The majority of studies comparing different anti-dsDNA antibody assays focused on the ability to discriminate between SLE and controls. 8,10,13,18,27 Only a few studies have analyzed the tests for their performance to measure disease activity in SLE patients. [4][5][6][7]15 Our data demonstrated that the novel CIA shows a good correlation to the disease activity measured by the SLEDAI-2K score.…”

“…The principle of the BIO-FLASH system and QUANTA Flash dsDNA assay was recently described. [17][18][19]26 The QUANTA Flash assay for this study was developed using synthetic dsDNA coupled to the surface of paramagnetic beads. The cut-off was established during the development of the assay, using a reference population of apparently healthy blood donors, in accordance to Clinical and Laboratory Standards Institute (CLSI) C28-A3c in Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory: Approved Guidelines, 3rd Ed.…”

“…[8][9][10][11][12][13][14][15] Such technologies include multiplex systems, fluoro-enzyme immunoassays (FEIA), and chemiluminescent immunoassays (CIA), which were shown to be comparable to other traditional methods in previous studies. [16][17][18][19][20][21][22][23] The goal of the present multicenter study was to assess the diagnostic performance of the QUANTA Flash dsDNA CIA in comparison with an ELISA, using patients from five participating countries. Secondly, we investigated the utility of this assay for the clinical management of SLE patients by analyzing the correlation of results to the SLE disease activity index (SLEDAI-2K) in these patients.…”

Chemiluminescent immunoassay technology: what does it change in autoantibody detection?

“…Furthermore, the current availability of novel antigenic preparations (recombinant, highly purified extracts, circular plasmids and synthetic oligonucleotides), along with other methodological improvements, has led to the production of new generation immunoassays that are able to detect anti-dsDNA only of intermediate and high avidity [49]. Consequently, the detection of anti-dsDNA autoantibodies for the diagnosis of SLE can be reliably executed by adopting the latest immunoassay techniques, which includes CLIA methods, and reports a quantitative result [50, 51]. …”