Saurabh Bandhavkar
Hepatitis B caused by hepatitis B virus (HBV) is regarded as the most common form of chronic hepatitis worldwide. Around 15%-40% of people infected with HBV develop HBV-related complications and approximately 25% die as a result of these complications. Since HBV is infectious and spreads through blood, semen and other body fluids, it will be easy to detect the presence of this virus in these body fluids. Polymerase chain reactions (PCR) assays are often employed to detect these viruses in blood. While most of these assays generally rely on detection of HBV Surface Antigen (HBsAg) or hepatitis b core IgM Antibody (anti-HBc IgM), recent developments have made possible the detection of HBV DNA in blood. These assays, however, necessitate the requirement of adequate controls to distinguish true from false negative results. To address this issue, we have developed positive controls for Hepatitis B virus using molecular biology techniques. These controls can be used in PCR assays for detection of HBV by competitive amplification, thereby allowing detection of false negatives. The controls developed in this study were successfully tested with virus-seeded blood sample concentrates.