Evaluation of an anti-HCV chemiluminescence assay: Enhancing diagnostic accuracy and reducing false positives in hepatitis C screening.

OBJECTIVES

Detection of antibodies is recommended for the diagnosis and effective treatment of hepatitis C. This study evaluated the performance of a new chemiluminescence assay for detecting hepatitis C virus (HCV) antibodies and compared it with previous assays using a comprehensive set of routine and borderline samples.

METHODS

A total of 2,216 serum samples were included in this study, comprising of 2,121 routine clinical samples and 95 borderline cases (COI range: 0.9-5.0). We compared the Anti-HCV-2 assay's (Mindray Diagnostics, Shenzhen, China) performance with the Anti-HCV-1 assay, assessing key parameters including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Precision was tested using replicate samples, and accuracy was validated through confirmatory RIBA (Mikrogen GmbH, Neuried, Germany) and Elecsys Anti-HCV assays (Roche Diagnostics, Mannheim, Germany). Interference testing was conducted to assess the assay's robustness against common substances found in clinical samples.

RESULTS

The Anti-HCV-2 assay demonstrated high sensitivity (98.2 %), specificity (99.1 %), and accuracy (98.7 %) in routine clinical samples. For borderline cases, the accuracy of Anti-HCV-2 was significantly higher (96.84 %) compared to Anti-HCV-1 (3.16 %). Precision testing showed a coefficient of variation (CV) of <2 %, indicating excellent reproducibility. Anti-interference testing confirmed that the Anti-HCV-2 assay performed consistently across samples with common interferences, such as hemolysis and lipemia.

CONCLUSION

The Anti-HCV-2 assay outperforms the Anti-HCV-1 assay in terms of accuracy, reproducibility, and reliability, especially in the range of borderline, making it a valuable tool for routine HCV screening.