Comparative Evaluation of Three Diagnostic Tools for the Detection of Hepatitis C Virus among High-risk Individuals in a Tertiary Care Centre of Northeast India

Abstract

Introduction: Hepatitis C virus (HCV) has posed a major public health problem globally. Since majority of HCV infected patients are asymptomatic, diagnosis of HCV infection is mainly based on the detection of anti-HCV antibodies by the Enzyme Linked Immunosorbent Assay (ELISA) or Rapid Diagnostic Tests (RDTs) and HCV Ribonucleic Acid (RNA) by real time Polymerase Chain Reaction (PCR) of serum or plasma samples. Aim: To assess the performance of RDT and 4th generation ELISA against real time reverse transcriptase PCR for the detection of HCV. Materials and Methods: A hospital-based cross-sectional study was carried out in the Virology Section, Department of Microbiology, Jawaharlal Nehru Institute of Medical Sciences (JNIMS), Imphal, Manipur, India, for a period of two years from June 2019 to May 2021. The study included 3,254 plasma samples from suspected cases of HCV monoinfection, and HCV/HIV co-infection. The plasma samples were subjected to anti-HCV antibodies by RDT (SD BIOLINE, South Korea) and 4th generation ELISA (Monolisa™ HCV Ag-Ab ULTRA, BioRad, France), and HCV RNA by real time PCR. Data analysis was done using descriptive statistics, and performance of the assays was evaluated by using Cohen kappa test (κ) and Receiver Operating Characteristic (ROC) curve. Results: PCR is considered as the gold standard test. HCV was detected by RDT in 453 (13.92%), ELISA in 413 (12.69%) and RT-PCR in 367 (11.28%) samples. The present study demonstrated sensitivity of 97.55% and specificity of 96.71% with Positive Predictive Value (PPV) of 79.03% by HCV-RDT. The 4th generation ELISA showed high sensitivity of 99.46% and specificity of 98.34%. Using ROC curve, the area under the curve was 81% for ELISA with diagnostic accuracy of 98.46%. Conclusion: 4th generation ELISA is more sensitive and specific than RDT for the detection of HCV infection. Confirmatory HCV-RNA assay could be performed to clear doubts related to false-positive and false-negative findings of the primary screening assays.