Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

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.