Relative value of commercial kits for ANA testing

Clin Exp Rheumatol. 2003 Jul-Aug;21(4):477-80.


Aims: We have tested the relative performance of 20 commercial ANA test kits along with that of our own laboratory to assess whether one was clearly superior.

Methods: The sera were drawn from 3 pools that had all been pre-tested in our laboratory: patients with definite SLE; patients with non-connective tissue diseases (CTD), but where a positive FANA had been found; and normal blood donors. The tests were used in accordance with the recommendations of the specific supplier but in a routine serology laboratory.

Results: Sensitivity and specificity ranged between 38 and 100%. While the negative predictive value of 4 ELISA kits was 100%, and most others were close, the HEp-2 kits were 100% in only 1 case. A positive predictive value of 100% was also seen with 1 kit.

Conclusion: Some of the tests are clearly better than others, but the choice may differ depending on the clinical needs, e.g. preference for a good positive or negative predictive value. However, the ELISA kits offered better results than the immunofluorescent technique. Two of them had sensitivity/specificity of > 90%.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Antibodies, Antinuclear / analysis*
  • Enzyme-Linked Immunosorbent Assay
  • Fluorescent Antibody Technique, Indirect
  • Humans
  • Lupus Erythematosus, Systemic / diagnosis*
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Sensitivity and Specificity


  • Antibodies, Antinuclear
  • Reagent Kits, Diagnostic