Quantitative detection of anti-centromere antibodies in primary biliary cholangitis: value of chemiluminescence immunoassay.

OBJECTIVE

To investigate chemiluminescence immunoassay (CLIA) in detecting anti-centromere antibodies (ACA) in primary biliary cholangitis (PBC) patients.

METHODS

In this retrospective study, 165 patients diagnosed with PBC at Hangzhou Xixi Hospital between December 2020 and January 2023 were enrolled. ACA positivity was assessed using three methods: indirect immunofluorescence (IIF), line immunoassay (LIA), and CLIA. The agreement among the methods was evaluated using kappa statistics and correlation analysis. Logistic regression was used to assess the association between ACA positivity and portal hypertension. Receiver operating characteristic (ROC) curve analysis was performed to compare the predictive performance of CLIA and LIA for portal hypertension.

RESULTS

Among the 165 PBC patients, 69 (41.8%), 68 (41.2%), and 66 (40.0%) were ACA-positive by IIF, LIA, and CLIA, respectively. CLIA showed excellent agreement with IIF (κ = 0.962) and LIA (κ = 0.975), and a strong correlation with LIA in quantitative detection (R = 0.893, p < 0.001). Logistic regression confirmed that ACA positivity was significantly associated with portal hypertension (OR = 2.726, 95% CI: 1.437-5.169, p = 0.002). CLIA demonstrated superior predictive performance over LIA for portal hypertension (AUC: 0.705 vs. 0.638, p = 0.001).

CONCLUSION

CLIA exhibits excellent concordance with conventional methods for detecting ACA and provides a broader linear range for quantitative assessment. ACA positivity was significantly associated with portal hypertension in PBC patients. The main advantage of CLIA lies in its precise quantification of ACA and prognostic value, highlighting its potential role in risk stratification and disease monitoring in PBC patients.