Why This Matters:
- Hepatitis B virus (HBV) infection remains a major global public health burden, with an estimated ~250–300 million people living with chronic infection worldwide.
- Chronic HBV infection is defined by persistence of viral antigen for more than six months and is characterized by ongoing viral replication, management relies on accurate quantification of HBV DNA.
- Standard HBV DNA testing requires venous draw, centralized laboratory processing, and often delayed turnaround times.
- A reliable fingerstick POC HBV DNA test could enable same-visit treatment decisions, expanding access in clinics, low-resource settings, and community screening programs.
- Rapid, decentralized HBV DNA measurement has implications for improving linkage to care, reducing loss to follow-up, and optimizing individualized therapy.
Key Findings: The study prospectively undertaken at 6 hospitals assessed 246 adult participants with chronic HBV infection and compared results from a fingerstick capillary blood obtained using the Xpert HBV Viral Load assay against a laboratory-based quantitative HBV DNA reference standard (OBAS AmpliPrep/ COBAS TaqMan HBV DNA Test).1
- High agreement with reference PCR: Fingerstick POC results showed strong concordance with laboratory HBV DNA quantitation across the relevant viral load range. While the Xpert assay reported HBV DNA levels 32% higher than those of the reference assay, the correlation between the two assays was very tight (r = 0.9824, P < 0.001).
- Sensitivity and specificity: At clinically actionable cutoffs, the POC test demonstrated robust sensitivity and specificity, indicating it can reliably identify patients meeting treatment criteria.
- Blood samples with HBV DNA ≥100 IU/mL, sensitivity = 97.0%, specificity = 90.3%.
- Blood samples with HBV DNA >2,000 IU/mL, sensitivity = 95.3%, specificity = 95.0%.
- Feasibility: Fingerstick collection was well tolerated, required minimal training, and provided results within a clinically useful timeframe.
- Point-of-care utility: The study supports the potential to integrate POC HBV DNA testing into routine clinical workflows to accelerate therapeutic decision-making.
Bigger Picture: Expanding access to HBV DNA quantitation is a critical step toward improving care for people living with chronic hepatitis B. Traditional laboratory testing infrastructure can be a bottleneck that delays treatment initiation, monitoring, and public health interventions. Fingerstick POC assays with demonstrated accuracy may enable real-time, decentralized management, aligning with global WHO hepatitis elimination goals by closing diagnostic gaps in underserved and high-burden settings. Continued validation across diverse populations, viral genotypes, and clinical contexts will be important to confirm generalizability and inform guideline incorporation.
(Image Credit: iStock/ 101cats)
