Funding not awarded. A new study design and protocol have been submitted

Evaluation of novel point of care Hepatitis B diagnostic assays.

This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;

• GeneXpert HBV DNA via Fingerstick testing,
• Dried Blood Spot based HBV DNA
• Point of care ALT.

Inclusion Criteria:

1. Have voluntarily signed the informed consent form.
2. 18 years of age or older.
3. HBsAg positive
4. Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Participants will be enrolled into the study in two parts until the following sample sizes are met for the prospective samples Part A: At least 30 paired specimens of venous EDTA whole blood and DBS in treatment naive adults (HBV DNA detectable) Part B: At least 30 paired specimens of venous EDTA whole blood and DBS in HBV DNA undetectable adults on antiviral therapy