Comparative Study between ELISA and TrueNat for Hepatitis B Virus and Hepatitis C Virus among Antenatal Women Attending Tertiary Care Medical Institute in Manipur, India

Introduction: Viral hepatitis is one of the leading causes of death and disability. Nearly 1.5 million people die every year from Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) related liver diseases. Reported consequences of HBV and HCV infection in pregnancy include an increased likelihood of occurrence of preterm delivery and low birth weight and perinatal transmission.

Aim: To compare Enzyme-Linked Immunosorbent Assay (ELISA) and closed system Polymerase Chain Reaction (PCR) TrueNat for the detection of HBV and HCV among antenatal women attending a tertiary care medical institute.

Materials and Methods: This was a hospital-based cross-sectional study conducted at the Department of Microbiology, JNIMS, Imphal, Manipur, India, during the period from December 2020 to January 2022. Serum samples were tested using ELISA as well as on the TrueNat PCR. Data was analysed using Statistical Package for the Social Sciences (SPSS) version 23.0.

Results: Out of 60 samples, using ELISA (QUALISA), 24 were found to be positive for HBV surface antigen (HBsAg) and 14 were found to be positive for HCV antibodies (HCV Ab). On further testing using TrueNat chip-based closed system Real Time-PCR (RT-PCR) Test, 12 were found to be positive for HBV Deoxyribonucleic Acid (DNA) and five were found to be positive for HCV Ribonucleic Acid (RNA).

Conclusion: TrueNat PCR could eliminate the problem of false positivity in the detection of HBV and HCV. It is useful to make clinical decisions on starting antiviral therapy and also in documenting the efficacy of the antiviral therapy.