New Delhi, May 09, 2022.

Global healthcare leader Abbott has announced the launch of the HBsAg Next Qualitative solution in India to enhance detection of the Hepatitis B virus (HBV). This assay will help improve patient outcomes while maintaining safe blood supplies. This highly sensitive chemiluminescent microparticle immunoassay (CMIA) assists in the early and enhanced detection of HBV in human serum and plasma (blood) samples and in population screening. A chemiluminescent immunoassay is a variation of the standard enzyme immunoassay, a biochemical technique used in immunology.

Early identification of HBV infections allows patients to receive the necessary care to prevent or delay progression of advanced liver diseases. Moreover, it also reduces the risk of transmission.

The HBsAg Next Qualitative assay is an advanced, next generation solution to better support the earlier detection of HBV. It detects HBV surface antigen (HBsAg) in human serum and plasma. Moreover, it overcomes traditional challenges by showcasing the highest level of assay performance required to detect infection in immunocompromised groups.

Dr. Jaganathan Sickan, Senior Associate Director, Medical Affairs, Core Diagnostics at Abbott said, “In India, Hepatitis B screening is vital since it is vastly under diagnosed. With HBsAg Next qualitative assay, laboratories in India can now detect HBV earlier than ever. This will help physicians identify at risk patients sooner, which in turn leads to early treatment and care. This assay represents the next generation of HBV diagnostic performance and will enhance our comprehensive infectious disease portfolio.”

Hepatitis B is a liver infection caused by Hepatitis B virus. It can be acute or chronic, with chronic cases potentially leading to liver failure, cirrhosis, or liver cancer. About 296 million people worldwide currently live with chronic hepatitis B,[i] with 10 to 15% of the world’s HBV carriers (40 million) found in India alone.[ii] Moreover, co-infections with HIV are also prevalent, with roughly 1 in 10 people living with HIV estimated to have Hepatitis B. However, Hepatitis B virus is often silently undiagnosed, with only 10.5% of all people estimated to be living with Hepatitis B aware of their condition.[iii]

Dr. Ekta Gupta, Professor, In-Charge, Department of Clinical Virology, ILBS, New Delhi, said, “The national burden of Hepatitis B is significant but due to the extremely low rate of diagnosis in India, we are unaware of the actual situation. This assay not only aids in earlier detection of the infection, it reduces the risks of undetected virus. With such highly sensitive qualitative assays, doctors will be able to identify at-risk patients and provide appropriate treatment sooner.”

With the HBsAg Next Qualitative Solution, laboratories can now better detect, analyze the infection and reduce the risks of undetected virus, have a consistent detection of all HBV genotypes and enhance detection and confirmation of mutants. Additionally, it can detect HBV in specimens on Abbott’s Alinity i or ARCHITECT systems. Testing for HBV can be performed for diagnostic purposes, as a screening test, or even after death (post-mortem) to prevent HBV spread to recipients of blood, blood components, cells, tissues, and organs.

Dr. John Fletcher, Professor, Dept of Clinical Virology, CMC Vellore commented, “CMC’s commitment to screen HBsAg started around 1970s and we continue to embrace the state-of-the-art technologies and chemistries. HBV identification involves overcoming several obstacles like window identification, detection of mutants, occult infections, breakthrough infections and reactivations.

Next generation HBsAg assays with superior performance characteristics can enhance stringent early detection and identification of challenging phases of HBV infections as well as efficient monitoring of functional cure. Cumulatively, these benefits converge to significantly reduce the risk of transmission and overall improve the global continuum of care by reducing the pernicious first gap.”  

The World Health Organization (WHO) has set targets to eliminate viral hepatitis as a public health concern by 2030 to reduce infection incidence and related complications. Effective diagnostic solutions for early and accurate diagnosis can help achieve these goals. The HBsAg Next assay, with better sensitivity and specificity, will help India advance towards its goals of HBV diagnostics and care.