Advancing HBV Diagnostics: The Role of Ultrasensitive HBsAg Testing.

Area of Science:

• Hepatology
• Virology
• Diagnostic Assays

Background:

• Hepatitis B virus (HBV) infection affects over 254 million globally, causing 1.1 million deaths annually.
• The World Health Organization aims to eliminate HBV by 2030, but only 13% of infected individuals receive timely diagnosis and treatment.
• Current diagnostic methods struggle to detect early-stage infections, occult HBV infections (OBI), and HBV reactivation.

Purpose of the Study:

• To review the challenges in current Hepatitis B virus diagnostics.
• To examine the clinical utility of ultrasensitive HBsAg assays in improving HBV diagnosis and treatment monitoring.
• To assess the role of ultrasensitive assays in achieving global HBV elimination targets.

Main Methods:

• Review of existing literature on HBV diagnostics and ultrasensitive HBsAg assays.
• Comparison of the limit of detection (LoD) between conventional and ultrasensitive HBsAg assays.
• Analysis of research demonstrating the superiority of ultrasensitive assays in detecting low HBsAg concentrations.

Main Results:

• Conventional HBsAg assays (LoD: 0.03-250 IU/mL) often miss OBI and HBV reactivation.
• Ultrasensitive HBsAg assays (LoD: as low as 0.005 IU/mL) can detect lower HBsAg levels.
• Ultrasensitive assays improve the identification of HBV in cases missed by conventional methods, detect NAT-yield samples, and enable earlier detection of HBV reactivation.

Conclusions:

• Ultrasensitive HBsAg assays offer superior diagnostic capabilities for HBV.
• These assays are vital for early diagnosis, monitoring treatment response, and assessing functional cure.
• Implementing ultrasensitive assays is critical for advancing global HBV elimination efforts.