Performance evaluation of Elecsys analysis system for anti-cyclic citrullinated peptide detection in comparison with commercially available ELISA assays in rheumatoid arthritis diagnosis

Clin Biochem. 2011 Aug;44(12):989-93. doi: 10.1016/j.clinbiochem.2011.05.021. Epub 2011 May 25.

Abstract

Objectives: To evaluate performance consistency of electrochemical luminescence with ELISA for anti-cyclic citrullinated peptide (CCP) antibodies detection and define their diagnostic efficacy on rheumatoid arthritis (RA).

Design and methods: Serum anti-CCP antibodies of 144 subjects (93 RA, 17 non-RA autoimmune diseases,11 involution diseases and 23 healthy volunteers) were simultaneously determined by Elecsys assay, Immunoscan CCPlus Euro-diagnostica ELISA kit and Euroimmun anti-CCP ELISA kit.

Results: The consistent rate and Kappa coefficients among three assays were all more than 0.97. AUCs of ROC for anti-CCP antibodies detection by Elecsys, Euro-diagnostica ELISA and Euroimmun ELISA assays were respectively 0.790, 0.773 and 0.794 (all P values=0.000), and under the optimal cutoff values their diagnostic accurate rates for RA diagnosis were 78.47%, 77.08% and 76.39% respectively.

Conclusions: The diagnostic performance of Elecsys assay for anti-CCP antibodies detection was satisfactory and comparable to that of classical ELISA assay. Under the same specificity Elecsys assay has a slightly but not significantly higher diagnostic accuracy and sensitivity than ELISA assay.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies / blood*
  • Arthritis, Rheumatoid / diagnosis*
  • Case-Control Studies
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Peptides, Cyclic / blood
  • Peptides, Cyclic / immunology*
  • ROC Curve
  • Young Adult

Substances

  • Antibodies
  • Peptides, Cyclic
  • cyclic citrullinated peptide