Validation of Analytical Performance and Diagnostic Effectiveness of Anti-CCP Antibody Based on the Light-Initiated Chemiluminescence Assay.

Objective: To evaluate the analytical and diagnostic performance of anti-cyclic citrullinated peptide (anti-CCP) antibody measured by the light-initiated chemiluminescence assay (LICA).

Methods: A total of 193 patients with rheumatoid arthritis (RA) and 211 controls were included. Serum anti-CCP levels were assessed by LICA and enzyme-linked immunosorbent assay (ELSIA). The analytical performance of LICA anti-CCP assay was evaluated according to the clinical guidelines. The diagnostic performance of LICA anti-CCP assay was evaluated by a series of indicators such as sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) compared with ELISA. The dynamic consistency of the two methods was compared by patient follow-up.

Results: The LICA anti-CCP assay showed coefficient of variation of 0.6% - 3.3% and linearity within 10-500 U/mL with a correlation coefficient of 0.991. The LICA and ELISA showed similar sensitivity (88.60% vs 92.94%) and specificity (97.60% vs 94.95%) on determination of anti-CCP. The AUCs of anti-CCP detected by LICA and ELISA were 0.971 and 0.955 (=0.052), respectively. Follow-up showed that the changes of anti-CCP measured by the two methods were consistent.

Conclusions: LICA anti-CCP assay has good analytical and diagnostic performance for RA, which is comparable to ELISA, and has dynamic consistency.