The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell
-
Christoph Robier
,
Maximiliane Haas
Abstract
Objectives
Data on the clinical importance of the detection of anti-dsDNA antibodies in patients with negative indirect immunofluorescence on the HEp-2 cell (IIF) are sparse and are especially not available for all common commercially available assays. This study aimed to assess the clinical significance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative IIF.
Methods
We retrospectively examined the medical records of 234 consecutive subjects with detectable anti-dsDNA antibodies determined by the Elia™ dsDNA assay.
Results
A total of 124 subjects with detectable anti-dsDNA autoantibodies were IIF-negative, but yielded positive or borderline results in the Elia™ CTD screen assay for antinuclear antibodies (ANA). Within this group, 6/49 IIF-negative patients (12%) with ANA-associated systemic autoimmune rheumatic disorders (AASARD) and 118/185 subjects (64%) with various other diseases (Non-AASARD) were identified. There was no statistically significant difference with regard to the concentrations of anti-dsDNA antibodies (p=0.53) between the AASARD and the Non-AASARD group. Within the AASARD group, four patients diagnosed with systemic lupus erythematosus (SLE, treated), discoid lupus erythematosus (untreated), indetermined connective tissue disease (untreated) and polymyositis (treated) had positive anti-dsDNA autoantibodies, whereas two patients with treated SLE, thereby one in remission, had borderline concentrations of anti-dsDNA antibodies.
Conclusions
Our findings suggest that the detection of anti-dsDNA antibodies in IIF-negative patients can be of clinical relevance in some cases. Our results further support the combined use of IIF and solid-phase assays in screening algorithms for ANA, in order to avoid overlooking potentially important autoantibody entities.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: CR received travel grants and lecture fees from Phadia/Thermo Fisher Scientific. All other authors state no conflict of interest. The company was not involved in the study design, the collection, analysis and interpretation of data, in the writing process and the decision to submit the manuscript for publication. Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: This study was approved by the Ethics Committee of the Hospital of the Brothers of St. John of God in Graz and was performed in accordance with the Declaration of Helsinki.
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© 2020 Walter de Gruyter GmbH, Berlin/Boston
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- The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell
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Articles in the same Issue
- Frontmatter
- Editorial
- Complex analytical procedures in diagnostic laboratories and the IVDR
- Review
- Re-examining ferritin-bound iron: current and developing clinical tools
- Opinion Papers
- Designing a diagnostic Total Testing Process as a base for supporting diagnostic stewardship
- The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications
- EFLM Papers
- The Academy of the European Federation of Clinical Chemistry and Laboratory Medicine and the European Register of Specialists in Laboratory Medicine: guide to the Academy and the Register, version 4 – 2020
- A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications)
- Guidelines and Recommendations
- High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy
- General Clinical Chemistry and Laboratory Medicine
- Measurement of serum 17-hydroxyprogesterone using isotope dilution liquid chromatography-tandem mass spectrometry candidate reference method and evaluation of the performance for three routine methods
- Evaluation of carbohydrate-deficient transferrin measurements on the V8 capillary electrophoresis system and comparison with the IFCC approved HPLC reference method and N-Latex immunonephelometric assay
- The clinical relevance of anti-dsDNA antibodies determined by the Elia™ dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2 cell
- A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays vs. indirect immunofluorescence for initial screening of connective tissue diseases
- Individual uromodulin serum concentration is independent of glomerular filtration rate in healthy kidney donors
- Comparison of iohexol plasma clearance formulas vs. inulin urinary clearance for measuring glomerular filtration rate
- Overweight-obesity is associated with decreased vitamin K2 levels in hemodialysis patients
- Cardiovascular Diseases
- Evaluating the performance of an updated high-sensitivity troponin T assay with increased tolerance to biotin
- Infectious Diseases
- The anti-inflammatory cytokine response characterized by elevated interleukin-10 is a stronger predictor of severe disease and poor outcomes than the pro-inflammatory cytokine response in coronavirus disease 2019 (COVID-19)
- Quantification of the HIV-1 total reservoir in the peripheral blood of naïve and treated patients by a standardised method derived from a commercial HIV-1 RNA quantification assay
- Comparison of the reliability of Gram-negative and Gram-positive flags of the Sysmex UF-5000 with manual Gram stain and urine culture results
- Evaluation of a turbidimetric C-reactive protein assay to monitor early-onset neonatal sepsis in South Kivu (Democratic Republic of the Congo)
- Corrigendum
- Corrigendum to: Procalcitonin (PCT)-guided antibiotic stewardship in Asia-Pacific countries: adaptation based on an expert consensus meeting
- Letters to the Editor
- Decision-making based on sFlt-1/PlGF ratios: are immunoassay results interchangeable for diagnosis or prognosis of preeclampsia?
- Inter-center agreement in the interpretation of oligoclonal bands
- A new founder BRCA1 haplotype identified in the Puglia region is associated with a specific age-related cancer onset in three unrelated families
- Predictive values of D-dimer for adverse pregnancy outcomes: a retrospective study
- A very uncommon haemoglobin value resulting from a severe acute malnutrition in a 16-month-old child in Ethiopia
- Ionized calcium measurements during continuous renal replacement therapy with regional citrate anticoagulation
- The hairy cell leukaemia oxymoron: monocytotic monocytopenia
- Perchlorate interference with electrolyte analysis
- False decrease in serum triglyceride and cholesterol due to massive ascorbate in a bowel preparation solution
