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Comparison of three anti-dsDNA assays: performance and correlation with systemic lupus erythematosus disease activity.

AbstractOBJECTIVE:
To investigate the BioPlex 2200 multiplex immunoassay and Farrzyme ELISA assays as alternatives to the established Farr radioimmunoassay for the correlation of anti-dsDNA antibodies in the assessment of disease activity in systemic lupus erythematosus (SLE).
DESIGN AND METHODS:
Standard protocols were used to verify analytical performance claims. Anti-dsDNA antibody levels in SLE patient specimens (N=105) were measured and assessed for clinical performance using manufacturer cut-off limits along with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
RESULTS:
Assay precision, measurable range and normal reference interval met the manufacturers' stated claims. Agreement between Farr and BioPlex assays was moderate (positive agreement=62%; negative agreement=85%; kappa=0.48), as was agreement between Farr and Farrzyme assays (positive agreement=56%; negative agreement=91%; kappa=0.51). Mean SLEDAI-2K scores differed significantly between the anti-dsDNA positive and negative groups for BioPlex (p=0.0006), but not Farr (p=0.11) or Farrzyme (p=0.34). ROC curve analysis showed a similar area under the curve (AUC) for all three assays (0.76, 0.74, and 0.73 for Farr, BioPlex, and Farrzyme, respectively) in the discrimination of clinically active disease. Furthermore, increased anti-dsDNA levels from BioPlex showed significant correlation with active renal disease. However, results suggested a lower cut-off for the Farrzyme assay for assessment of global disease activity.
CONCLUSIONS:
BioPlex and Farrzyme assays had similar overall agreement with the Farr assay, with BioPlex best reflecting disease activity in SLE patients.
AuthorsAllison A Venner, Dominique Ibañez, Dafna D Gladman, Murray B Urowitz, Anne MacKinnon, Ivan M Blasutig, Paul M Yip
JournalClinical biochemistry (Clin Biochem) Vol. 46 Issue 4-5 Pg. 317-20 (Mar 2013) ISSN: 1873-2933 [Electronic] United States
PMID23246539 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Autoantibodies
  • DNA
Topics
  • Adult
  • Aged
  • Autoantibodies (blood)
  • DNA (immunology)
  • Enzyme-Linked Immunosorbent Assay (standards)
  • Female
  • Humans
  • Lupus Erythematosus, Systemic (blood, diagnosis, immunology)
  • Male
  • Middle Aged
  • ROC Curve
  • Radioimmunoassay (standards)
  • Reference Standards
  • Young Adult

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