Analytical and clinical comparison of anti-CCP assays with rheumatoid factor for the diagnosis of rheumatoid arthritis

Clin Chim Acta. 2012 Jun 14;413(11-12):1015-7. doi: 10.1016/j.cca.2012.02.002. Epub 2012 Feb 14.

Abstract

Introduction: Rheumatoid arthritis (RA) is an inflammatory autoimmune disease characterized by chronic joint inflammation and extra-articular manifestations, eventually leading to permanent disability without early therapeutic interventions.

Methods: The analytical and clinical performance of an electrochemiluminescent immunoassay (ECLIA) (Roche Diagnostics, Indianapolis, IN) were determined for cyclic citrullinated peptide antibodies (anti-CCP) in the diagnostic assessment of rheumatoid arthritis compared to a plate-based anti-CCP enzyme immunoassay (EIA) (Inova Diagnostics, Inc.).

Results: Imprecision studies on the automated Roche ECLIA demonstrated intra-assay CV's of <3% and inter-assay CV's of <7%. The Inova EIA had intra-assay CV's of <15% and inter-assay CV's of <12%. The limit of quantitation of both assays was acceptable, and both assays showed similar linearity within the manufacturer's defined reportable ranges. Overall, analytical concordance was 62%, with 95.2% positive and 53.2% negative concordance. The clinical specificity in a normal population (n=91) was 98.9% and 100% for Roche ECLIA and Inova EIA, respectively. The clinical specificity in a connective tissue disease population (n=98) was 91.9% (95%CI, 86.0 to 96.5%) and 88.8% (95% CI, 81.0 to 93.6%) for Roche ECLIA and Inova EIA, respectively.

Conclusion: The Roche ECLIA demonstrated similar analytical performance, although with improved intra-assay precision, in comparison to the Inova EIA. The two methods also demonstrated similar clinical sensitivity and specificity. The Roche automated immunoassay is a viable alternative to the plate-based EIAs with the advantage of being performed on an automated platform.

Publication types

  • Comparative Study

MeSH terms

  • Arthritis, Rheumatoid / diagnosis*
  • Automation, Laboratory / methods
  • Connective Tissue Diseases / diagnosis
  • Female
  • Humans
  • Immunoassay / methods*
  • Immunoenzyme Techniques / methods
  • Luminescent Measurements / methods
  • Male
  • Peptides, Cyclic / immunology*
  • Reference Values
  • Rheumatoid Factor / analysis*
  • Rheumatoid Factor / immunology
  • Sensitivity and Specificity

Substances

  • Peptides, Cyclic
  • cyclic citrullinated peptide
  • Rheumatoid Factor