Current global applications of HBcrAg assays in the management of chronic hepatitis B.

Abstract

Hepatitis B core-related antigen (HBcrAg) is a vital marker for monitoring chronic hepatitis B (CHB) as it correlates with hepatitis B (HBV) DNA and covalently closed circular DNA (cccDNA). The iTACT-HBcrAg assay, approved in Japan, provides highly sensitive and automated testing, reducing patient burden by requiring smaller specimen volumes and offering shorter processing times. Crucial for managing HBV reactivation and predicting hepatocellular carcinoma, it delivers consistent and reliable results. In resource-limited regions, the HBcrAg-rapid diagnostic test (HBcrAg-RDT) facilitates early HBV detection and management. This point-of-care testing (POCT) tool requires no specialized equipment and provides results within 30 minutes, making it invaluable in areas lacking HBV DNA quantification. Trials in West Africa, Asia, and other developing regions demonstrate its sensitivity and specificity. Together, these advancements in iTACT-HBcrAg and HBcrAg-RDT assays enhance CHB patient care and contribute significantly to the global effort to eliminate HBV as a public health threat.