Diagnostic utility of the Elecsys anti-CCP assay in patients with rheumatoid arthritis. Issue 4 (July 2014)

• Record Type: Journal Article
• Authors: Ye, Huiming; Chen, Falin; Yan, Shuidi; Zhang, Yan; Fang, Zanxi; Su, Xiaosong; Cai, Weicheng; Zhang, Zhongying
• Is Part Of: Modern rheumatology. Volume 24:Issue 4(2014)
• Page Start: 580
• Page End: 584
• Publication Date: 2014-07
• Subjects: Rheumatology -- Periodicals; 616.723005
• DOI: 10.3109/14397595.2013.844386
• Languages: English
• ISSNs: 1439-7595

Abstract

<abstract> <title>Abstract</title> <p> <italic>Objective</italic>. The automatic anti-cyclic citrullinated peptide (anti-CCP) antibodies assay offered great advantages over traditional methods in terms of improved precision, reliability, technical simplicity, short turnaround time and high-speed throughput. In this study, we evaluated the main technical performance and diagnostic accuracy of the first automatic anti-CCP assay approved in China.</p> <p> <italic>Methods</italic>. The study comprised 106 rheumatoid arthritis (RA) patients, 203 non-RA rheumatic disease controls and 46 healthy persons. Anti-CCP, rheumatoid factor (RF), α<sub>1</sub>-acid glycoprotein, C-reactive protein and erythrocyte sedimentation rate were measured and compared. The precision, reference intervals for Chinese population and cut-off value for RA diagnosis, as well as the suitable diluent for anti-CCP were assessed. The positive rate and score of anti-CCP were compared with RF and acute-phase reactants, according to the new RA criteria.</p> <p> <italic>Results.</italic> Within- and between-run imprecision, expressed as the coefficient of variation, were 0.47–1.36% and 1.15–2.63%, respectively. Upper 95% reference limit of anti-CCP in healthy Chinese was 8.8 U/mL. The area under curve of the receiver operating characteristic(ROC) for anti-CCP and RF were 0.882 (95% CI 0.833–0.930) and 0.844 (95% CI 0.792–0.897), respectively. Based on the cut-off value set by ROC, compared to RF, anti-CCP had higher sensitivity (96.8% vs. 78.3%) and specificity (90.9% vs. 70.7%). With 17 U/mL set as the optimal cut-off for anti-CCP, the total positivity of anti-CCP was comparable to that of RF (76.4% vs. 75.5%), but the high-positivity rate of anti-CCP was significantly higher (74.5% vs. 62.3%, <italic>p</italic> < 0.005).</p> <p> <italic>Conclusions</italic>. Our results confirm anti-CCP as a more sensitive and specific marker than RF for the diagnosis of RA. The diagnostic performance of the Elecsys anti-CCP assay makes it a useful adjunct to clinical practice in the Chinese population.</p> </abstract>