Immunologic Research

, Volume 66, Issue 3, pp 340–347 | Cite as

Analytical variability in the determination of anti-double-stranded DNA antibodies: the strong need of a better definition of the old and new tests

  • Maria Infantino
  • M. Manfredi
  • M. Merone
  • V. Grossi
  • M. Benucci
  • F. Li Gobbi
  • F. Bandinelli
  • A. Damiani
  • P. Soda
Original Article


Anti-dsDNA antibodies are a heterogeneous group of antibodies, quite specific for SLE. Their variability is related to the assay used, the immunoglobulin class secondary antibody, and the dsDNA source. The standardization of measuring anti-dsDNA antibodies is still poor and different methods yield different results. Several novel technologies were developed during the last decades that represent viable alternatives to the traditional methods such as the chemiluminescent immunoassay (CIA) and multiplex flow immunoassay (MFI). Additionally, positive results for anti-dsDNA antibodies can be detected in patients with inflammatory arthritis (IA) treated with different biologics reducing its clinical specificity for SLE. Anti-dsDNA antibody levels were evaluated in 246 patient samples: 70 SLE and 176 disease control (including 96 IA during treatment with different biologics), using three enzyme immunoassays (indirect enzyme immunoassay, Bio-Rad Laboratories; chemiluminescent immunoassay, Inova Diagnostics; multiplex flow immunoassay, Bio-Rad Laboratories) and three Crithidia luciliae immunofluorescence tests (CLIFT) (Euroimmun AG, Bio-Rad Laboratories, INOVA Diagnostics). Diagnostic performances were assessed both including and excluding the IA patients. Agreements, measured by the Cohen’s Kappa between all methods, ranged from moderate to substantial (0.47–0.68). The clinical sensitivities for the anti-dsDNA antibody tests varied from 5.7% by CLIFT A up to 33.3% provided by EIA while the clinical specificities varied from 89.8% by MFI to 98.9% provided by CLIFT B and C. Newer technologies, such as MFI and CIA, showed great potential as a diagnostic application. Significant variations among anti-dsDNA antibody assays were observed confirming the lack of standardization.


Anti-dsDNA antibodies Standardization Intermethods variability SLE classification criteria 


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Maria Infantino
    • 1
  • M. Manfredi
    • 1
  • M. Merone
    • 2
  • V. Grossi
    • 1
  • M. Benucci
    • 3
  • F. Li Gobbi
    • 3
  • F. Bandinelli
    • 3
  • A. Damiani
    • 3
  • P. Soda
    • 2
  1. 1.Immunology and Allergology Laboratory UnitS. Giovanni di Dio HospitalFlorenceItaly
  2. 2.Computer Systems & Bioinformatics Laboratory, Department of EngineeringUniversity Campus Bio-MedicoRomeItaly
  3. 3.Rheumatology UnitS. Giovanni di Dio HospitalFlorenceItaly

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