Aim: Autoantibodies against cyclic citrullinated peptide (anti-CCP) are considered to be a sensitive
and specifi c marker for rheumatoid arthritis (RA). This study evaluated the diagnostic and analytical
performances of the automated anti-CCP assay. Materials and Method: Sera from 80 patients with
established RA, 65 from other rheumatic diseases (non-RA) and 55 from healthy controls were
studied using second generation anti-CCP. Rheumatoid factor (RF) was also assayed in each sample,
and the results were compared to the anti-CCP fi ndings. Serum pools were used to determine the
precision and linearity. Results: At a cut-off of 7.4 U/ml for anti-CCP, the sensitivity and specifi city
for RA were 65% and 98% respectively. RF had a sensitivity of 58% and a lower specifi city of
93 % than anti-CCP. Conclusion: The high specifi city of the assay suggests that anti-CCP
is useful in the diagnosis of rheumatoid arthritis and in our cohort of study population
anti-CCP exhibits a better diagnostic value than RF. A considerable proportion (28%) of
RF-negative RA patients were anti-CCP positive. Based on analytical performance of the
assay, we conclude that full automation and high throughput features of AxSYM makes it
an ideal platform for routine testing of anti-CCP.