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

Bentow, Chelsea; Lakos, Gabriella; Martis, Peter; Wahl, Elizabeth; Garcı́a, M. C.; Viñas, Odette; Espinosa, Gerard; Cervera, Ricard; Sjöwall, Christopher; Carmona-Fernandes, Diana; Santos, María José; Hanly, John G.; Mähler, Michael

doi:10.1177/0961203316640917

Cited by 31 publications

(29 citation statements)

References 30 publications

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“…For example, anti-DNA antibodies seem more likely to be present during clinical manifestations compared to other commonly found autoantibodies against nuclear components, like Sm or Ro antigens (see Glossary), that do not correlate well with severity of disease [7]. It is likely that the heterogeneous pathology of SLE is in fact a consequence of immune dysregulation across various immunological pathways including many elements such as: i) deficiencies in complement [8], ii) the prevalence of anti-RNA or anti-DNA antibodies [9], and iii) inflammatory components: e.g. mutations in exonucleases like TREX1, which degrade reverse-transcribed DNA retroelements, and results in an IFN-associated disease in humans [10].…”

Section: Heterogeneity Of Systemic Lupus Erythematosusmentioning

confidence: 99%

Expanding the B Cell-Centric View of Systemic Lupus Erythematosus

Morawski

Bolland

2017

Trends in Immunology

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Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by a breakdown of self-tolerance in B cells and production of antibodies against nuclear self-antigens. Increasing evidence supports the notion that additional cellular contributors beyond B cells are important for lupus pathogenesis. In this Review, we consider recent advances regarding both pathogenic and regulatory roles of lymphocytes in SLE, beyond the production of IgG autoantibodies. We also discuss various inflammatory effector cell types involved in cytokine production, removal of self-antigens, and responses to autoreactive IgE antibodies. We aim to integrate these ideas to expand the current understanding of the cellular components that contribute to disease progression and ultimately help in the design of novel targeted therapeutics.

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Section: Heterogeneity Of Systemic Lupus Erythematosusmentioning

confidence: 99%

Expanding the B Cell-Centric View of Systemic Lupus Erythematosus

Morawski

Bolland

2017

Trends in Immunology

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“…The analytical performances including LOD, precision (including intra-assay and inter-assay), linearity and the effect of interfering substances were evaluated in accordance with relevant Clinical & Laboratory Standards Institute (CLSI) guidelines. 24 For our study we used a selection of 23 parameters including antibodies for vasculitis, thyroid, anti-Phospholipids syndrome, celiac disease, rheumatoid arthritis and ANA.…”

Section: Methodsmentioning

confidence: 99%

Concordance of the Analytical Performance of Autoimmune Antibodies on the Hob Bioclia® 1200 Automated Immunoassay Analyzer to the Phadia 250® System

Knies¹,

Olivo²,

Tönnies³

et al. 2019

IJMLR

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With more than 80 ADs (autoimmune diseases), e.g. Lupus or Rheumatoid arthritis, they are the third most common diseases worldwide.The diagnosis is difficult, because the generated autoantibodies are often not specific for a single disease. In fact, there is a need to increase the clinical efficiency inautoimmune diagnosis. Therefore, we tested and compared the CLIA-based HOB BioCLIA 1200®to the FEIA-based Phadia 250® systemin both, handling and performance. 23selected autoimmune parameters(e.g. in ANA, celiac disease or anti-phospholipids syndrome) and altogether 5982 measurements are done in our high-throughput lab. For the performance, the non-compliance and the κ-values are calculated to describe the effect of discrepant results. For 17 of 21 calculated parameters we found a good compliance, just fourparameters, e.g.the Rheumatoid arthritis parameter anti-RF-M and the celiac parameter anti-DGP-A, just substantial κ-values are shown. A reason for the anti-DGP-Acould be that celiac disease is not a relevant but rare disease in China. Thus the assay is far too sensitive or needs a higher reference range for a Caucasian patient poolas discussed with the manufacturers. The handling showed a stable running, random access system with an overall performance that makes it well usable in a medium sized laboratory.

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“…Anti-dsDNA antibodies are applied to diagnose and classify SLE, furthermore they indicate renal engagement and enhanced disease activity and thereby serve as a biomarker. However, anti-dsDNA levels are assumed to be lower, regardless of renal disease, in patients with inactive or well treated SLE (171,173,174). Crithidia luciliae as a source of antigen by indirect IF microscopy is used to detect ds-DNA with a specificity around 95% for SLE (171).…”

Section: Ana Fine Specificitiesmentioning

confidence: 99%

Antinuclear and antiphospholipid antibodies versus disease manifestations and clinical outcomes in systemic lupus erythematosus

Frodlund

2020

Linköping University Medical Dissertations

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Systemic lupus erythematosus (SLE) has an exceptionally heterogeneous clinical spectrum, ranging from mild disease limited to skin and joints to severe manifestations with renal disorder, central nervous system disease, severe cytopenias and thromboembolic events. Important clinical challenges include the prediction of disease flares and the identification of individuals that are likely to evolve severe disease with accrual of organ damage and worse prognosis. Autoantibodies, i.e. antinuclear antibodies (ANA) and antiphospholipid antibodies (aPL), and interferon alpha (IFN-α) that contribute to formation of immune complexes with nuclear antigens, are hallmarks considered to drive the disease in a vicious circle of antigen exposure, autoantibody production, inflammation and organ damage. There are few good biomarkers to predict severe SLE and organ damage. The aim of this PhD project was thus to increase the knowledge regarding ANA as well as aPL, and other potential biomarkers in relation to clinical features and disease outcomes in SLE. As expected, we found that the homogeneous ANA staining pattern was most common, and that it was associated with the occurrence of the 'immunological disorder' criterion. Speckled ANA was the second most common staining pattern, and it was inversely associated with arthritis, the 'immunological disorder' criterion and organ damage (Paper I). We also demonstrated that a considerable proportion of the patients lost ANA-positivity over time, whereas consistent staining patterns were most frequent (Paper V). Survival of patients with SLE has improved. Yet, in comparison to the general population, irreversible organ damage and increased mortality remains a critical concern. In Paper II, our cross-sectional analysis showed that more than a quarter of the patients had any aPL isotype (IgG, IgM or IgA class), and 14% were classified with antiphospholipid antibody syndrome (APS). A positive lupus anticoagulant (LA) test and/or IgG aPL tests were associated with most APS-related events and organ damage. Lupus nephritis, tobacco smoking, LA-positivity and the use of statins and/or corticosteroids were strongly associated with damage accrual, while hydroxychloroquine seemed to be protective. IgA aPL was not uncommon (16%) in Swedish cases of SLE, and analysis of IgA aPL may add information among clinically suspected APSpatients testing negative for LA and other aPL isotypes. Despite modern management and tax-funded health care with universal access, almost twothirds of the patients accrued organ damage over time, and the main causes of death were identified as malignancy, infection, and cardiovascular disease. We could confirm wellestablished risk factors for organ damage such as APS, hypertension, and/or the use of corticosteroids, but we also observed that other factors such as pericarditis, haemolytic anaemia, lymphopenia and myositis seems to be of importance in this view (Paper IV). We also demonstrated that levels of the extracellular matrix protein osteopontin (OPN) was correlated wit...

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

Abstract: The QUANTA Flash dsDNA assay showed good clinical performance in a large international multi-center study. Additionally, the strong correlation between anti-dsDNA antibody results and SLEDAI-2K scores supported the potential utility of QUANTA Flash dsDNA for monitoring disease activity.

Cited by 31 publications

References 30 publications

Expanding the B Cell-Centric View of Systemic Lupus Erythematosus

Expanding the B Cell-Centric View of Systemic Lupus Erythematosus

Concordance of the Analytical Performance of Autoimmune Antibodies on the Hob Bioclia® 1200 Automated Immunoassay Analyzer to the Phadia 250® System

Antinuclear and antiphospholipid antibodies versus disease manifestations and clinical outcomes in systemic lupus erythematosus

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