Evaluation of ICT and ELISA in Comparison to RT-PCR Assay in the Diagnosis of HCV Infection
Abstract
Background: Hepatitis C virus (HCV) infection is a major global health concern, often progressing to chronic liver disease, cirrhosis, and hepatocellular carcinoma if undiagnosed. Early and accurate diagnosis is critical for effective management. This study evaluated the diagnostic performance of the immunochromatographic test (ICT) and enzyme-linked immunosorbent assay (ELISA) in comparison to reverse transcription-polymerase chain reaction (RT-PCR) for HCV detection. Methods: A cross-sectional study was conducted among 50 participants, including 24 previously diagnosed HCV cases and 26 clinically suspected cases (History of HCV positive but no document and don’t take any treatment), at Chittagong Medical College and Chittagong Veterinary and Animal Science University between January 2019 and December 2019. Serum samples were tested for anti-HCV antibodies using ICT and ELISA. HCV RNA was detected using RT-PCR, considered the gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios were calculated to assess the diagnostic performance of ICT and ELISA. Results: The study population had a mean age of 39.16 ± 13.66 years, with a male-to-female ratio of 1.27:1. ICT and ELISA detected anti-HCV in 60% and 52% of cases, respectively. RT-PCR confirmed HCV RNA in 48% of participants. Compared to RTPCR, both ICT and ELISA showed 91.67% sensitivity. ELISA demonstrated higher specificity (82.62%) than ICT (69.23%). PPV and NPV were 84.62% and 91.67% for ELISA, and 73.33% and 90% for ICT, respectively. Conclusion: Both ICT and ELISA are highly sensitive for anti-HCV detection; however, ELISA provides superior specificity and predictive accuracy. RT-PCR remains essential for confirming active HCV infection. Integrating serological screening with molecular confirmation ensures reliable diagnosis and better clinical management of HCV infection. J MEDICINE 2026; 27: 67-71