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Harmonization and Standardization Challenges in Antidouble-Stranded DNA Detection: A Comparative Performance Study.

Khushboo Raj1, Shamshad Ahmad2, Kanu Tiwari3

  • 1Department of Biochemistry, NSMCH, Bihta, India.

Annals of African Medicine
|July 2, 2026
PubMed
Summary
This summary is machine-generated.

Discrepancies in anti-double-stranded DNA (dsDNA) antibody testing impact clinical interpretation for Systemic Lupus Erythematosus (SLE) patients. Evaluating multiple assays simultaneously improves understanding of antibody profiles and patient serology.

Keywords:
ADN double brinConcordanceLESSLEdouble-stranded DNAimmunodosage linéaireindirect immunofluorescence testline immunoassaytest d’immunofluorescence indirectetest d’immunofluorescence indirecte basé sur Crithidia luciliae

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Area of Science:

  • Clinical immunology
  • Autoantibody testing
  • Systemic Lupus Erythematosus (SLE) research

Background:

  • Commercial anti-double-stranded DNA (dsDNA) assays show analytical variability, complicating clinical interpretation.
  • Accurate detection of anti-dsDNA antibodies is crucial for SLE diagnosis and management.

Purpose of the Study:

  • To investigate the clinical implications of using two different anti-dsDNA assays in an SLE cohort.
  • To assess the concordance and discordance between anti-dsDNA testing methods and their association with clinical parameters.

Main Methods:

  • Retrospective analysis of SLE patients with simultaneous anti-dsDNA testing by Crithidia luciliae indirect immunofluorescence test (CLIFT) and ANA profile line immunoassay.
  • Descriptive analysis, concordance/discordance analysis, and multiple correspondence analysis were employed.
  • Association between dsDNA positivity, ANA screening, and renal status was examined.

Main Results:

  • All dsDNA-positive cases by CLIFT were ANA-positive by HEp-2 screening; however, 65.9% of dsDNA-negative cases were ANA-positive.
  • dsDNA positivity correlated with a homogenous ANA pattern and was associated with proteinuria.
  • Clustering revealed three distinct serological phenotypes based on antibody profiles.

Conclusions:

  • Significant discordance exists between CLIFT and line immunoassay for anti-dsDNA detection, particularly in dsDNA-negative samples with positive ANA screening.
  • The combined diagnostic utility of multiple anti-dsDNA assays should be considered for improved clinical interpretation in SLE patients.