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

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

Author information

  • 1Mayo Clinic, Department of Laboratory Medicine and Pathology, 200 First Street SW, Rochester, MN 55905, USA. Block.Darci@mayo.edu

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.

Copyright © 2012 Elsevier B.V. All rights reserved.

PMID:
22353668
[PubMed - indexed for MEDLINE]
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