Cross-sectional study compares enzyme-linked immunosorbent assay, chemiluminescence immunoassay, and rapid tests for detecting hepatitis C in blood donors, indicating optimal screening method.
Background: Hepatitis C virus (HCV) remains a major transfusion-transmissible infection, necessitating highly sensitive screening methods to ensure blood safety. Multiple serological assays are available for anti-HCV detection; however, their diagnostic performance varies. Aim: To compare the diagnostic efficacy of Enzyme-linked Immunosorbent Assay (ELISA), Chemiluminescence Immunoassay (CLIA), and Rapid Diagnostic Tests (RDTs) for the detection of anti-HCV antibodies among voluntary blood donors. Materials and Methods: A cross-sectional study was conducted on 70 voluntary blood donor samples at a tertiary care center. All samples were tested for anti-HCV antibodies using RDT, third-generation ELISA, and CLIA. Diagnostic performance was evaluated using sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and Cohen’s kappa coefficient. Results: CLIA demonstrated the highest sensitivity and diagnostic accuracy with no false-negative results, followed by ELISA. RDT showed comparatively lower sensitivity and agreement with laboratory-based assays. CLIA exhibited excellent concordance with ELISA and superior reliability in detecting anti-HCV antibodies. Conclusion: CLIA is the most effective screening modality for anti-HCV detection in blood donors, offering superior sensitivity, automation, and diagnostic accuracy. Its implementation as a primary screening tool can significantly enhance transfusion safety in tertiary care settings.
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Pari et al. (2026) studied this question.
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