Evaluation of Hepatitis B Virus (HBV) DNA Test As Point of Care Tool

This is a cross sectional observational study to asses the performance of two novel HBV DNA testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using the Xpert® Hepatitis B Virus viral load assay. Both novel testing methodologies will be compared with venous blood tested using a gold standard HBV DNA assay. The sensitivity and specificity of the two novel testing will be evaluated. HBV viral load tests are essential to guide antiviral treatment eligibility and effectiveness. However, many people are unable to access these tests, particularly those living in remote or limited resources settings given high cost, or unavailable infrastructure. Simple, affordable and accessible HBV viral load tests are required to increase global access to HBV testing and treatment to meet the WHO HBV elimination targets. The GeneXpert Diagnostic Systems, the most common molecular point-of-care platform globally, has the potential to provide simple and affordable HBV viral load tests. Dried Blood Spot testing is also an affordable and accessible testing methodology particularly suited to remote and resource limited settings. This proof-of-concept study will assess the feasibility and diagnostic performance of Xpert® HBV Viral Load test and Dried Blood Spot testing for the quantitation of HBV DNA from fingerstick capillary samples.