Diagnostic accuracy of the anti-citrulline antibody assay for rheumatoid arthritis.

نویسندگان

  • N Bizzaro
  • G Mazzanti
  • E Tonutti
  • D Villalta
  • R Tozzoli
چکیده

BACKGROUND Rheumatoid arthritis (RA) is the most common autoimmune rheumatic disease, but specific and practicable tests for its diagnosis are lacking. We evaluated the diagnostic accuracy of a new commercial ELISA in detecting anti-cyclic citrullinated peptide (CCP) antibodies for the diagnosis of RA. METHODS Anti-CCP antibodies were determined in 330 serum samples: 98 from RA patients and 232 from controls, including patients with connective tissue diseases, other rheumatic diseases, viral infections, Lyme disease, autoimmune thyroiditis, cancer, and monoclonal gammopathy, and sex- and age-matched healthy subjects. Intra- and interassay CVs were 5-13% and 9-17%, respectively. Rheumatoid factor (RF) was also assayed in every sample, and results were compared to anti-CCP for sensitivity and specificity. RESULTS At a cutoff value of 50 units, sensitivity was 41% (confidence interval, 31-50%) and specificity was 97.8% (95-100%). Anti-CCP-positive RA patients had a mean antibody concentration of 1100 units (range, 57-3419 units), and anti-CCP-negative RA patients and controls had mean values of 7.6 and 6.8 units, respectively (range, 1-39 units). The area under the ROC curve was 0.71 (95% confidence interval, 0.63-0.78). RF had a higher sensitivity (62%) and a lower specificity (84%) than anti-CCP. When the two antibodies were used together, specificity was 99.6%. CONCLUSION Anti-CCP antibody testing may be useful if performed concomitantly with RF assay to diagnose patients with suspected early RA.

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عنوان ژورنال:
  • Clinical chemistry

دوره 47 6  شماره 

صفحات  -

تاریخ انتشار 2001