›› 2012, Vol. 27 ›› Issue (6): 436-441.

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The analytical performance assessment and clinical practice of three Assays for the Measurement of anti-cyclic citrullinated peptide antibodies

  

  1. Department of Laboratory Medicine, Zhongshan Hospital, Fudan University School of Medicine, Shanghai 200032,China
  • Received:2012-02-07 Revised:2012-02-29 Online:2012-06-30 Published:2012-06-06

Abstract: Objective To evaluate the analytical performance of 3 assays for the measurement of anti-cyclic citrullinated peptide(CCP)antibodies, and compare the clinical application. Methods Serum samples from 93 patients with rheumatoid arthritis(RA),118 non-RA patients (82 patients with autoimmune diseases and 36 patients with osteo arthritis) and 20 healthy subjects were collected. The analytical performance of 3 reagents from Elecsys,Euroimmun and Fuchun was compared. The correlation was compared among the different reagents. The preliminary clinical application value for different reagents was evaluated. Results No statistical significance was found in precision of the 3 reagents.The within-run and interday coefficients of variation(CV)were <10 %. Both of Elecsys and Euroimmun could be evaluated as linearity in detection range,and the real linearity range of Fuchun was 25.0-1 027.9 RU/mL. The correlation of anti-CCP assays by the 3 reagents was good. The correlations (r) of Elecsys with Euroimmun and Elecsys with Fuchun were 0.90 and 0.87 respectively,and the r of Euroimmun with Fuchun was 0.97. According to the cut-off values proposed by the manufacturers,the diagnostic sensitivities were 83.9 % - 86.0 %, and the specificities were 92.0 % - 97.1 %.The areas under receiver operating characteristic (ROC) curve(AUC)of the anti-CCP assays by Elecsys, Euroimmun and Fuchun were 0.91, 0.92 and 0.89,respectively.There was no statistical difference between the AUC of any 2 assays(Z=0.27, 0.89 and 0.63,P>0.05). Conclusions Overall, the analytical performance of anti-CCP assays is comparable among the different assays,and their diagnostic characteristics are not significantly different.However, the standardization still has problems.

Key words: Anti-cyclic citrullinated peptide antibody, Rheumatoid arthritis, Precision;Linearity, Receiver operating characteristic curve, Anti-cyclic citrullinated peptide antibody, Rheumatoid arthritis, Precision, Linearity, Receiver operating characteristic curve