Hepatitis B virus (HBV) infection remains a global public health problem with changing epidemiology due to several factors including vaccination policies and migration.

An estimated 257 million people are living with hepatitis B virus infection (defined as hepatitis B surface antigen positive). But there is still limited access to diagnosis and treatment of hepatitis B in many resource-constrained settings. In 2015, of the 257 million people living with HBV infection, 9% (22 million) knew their diagnosis. Of those diagnosed, the global treatment coverage was only 8% (1.7 million). Many people are diagnosed only when they already have advanced liver disease. In May 2016, The World Health Assembly adopted the first "Global Health Sector Strategy on Viral Hepatitis, 2016-2020". The strategy has a vision of eliminating viral hepatitis as a public health problem and this is encapsulated in the global targets of reducing new viral hepatitis infections by 90% and reducing deaths due to viral hepatitis by 65% by 2030.

By applying real-time fluorescence quantitative PCR technology, this test utilizes a pair of specific primers which are designed to target at a conserved sequence of HBV-DNA, a specific fluorescence probe, accompanied with PCR mix, to achieve quantitative detection of HBV-DNA through fluorescent signal changes. The PCR detection system uses an internal control, which monitors the presence of PCR inhibitors in test specimens by detecting whether the internal control signal is normal, to avoid a false negative result.