Roche launches immunoassay to detect acute hepatitis B infection

The Elecsys HBeAg Quant detects the presence and amount of hepatitis B e antigen (HBeAg) in human serum and plasma.

Roche launches Elecsys HBeAg Quant, an immunoassay capable of detecting the presence and quantity of hepatitis B e-antigen (HBeAg) in human serum and plasma.

According to the manufacturer, Elecsys Quant, combined with other laboratory data and clinical information, will allow patients to find out whether they have hepatitis B virus (HBV) infection, the extent of the infection, and enable treatment monitoring with a single test.1 Elecsys HBeAg Quant is designed for use on cobas e analyzers in countries that accept CE marking, Roche said in a press release.

“Hepatitis B affects millions of people each year and is a major health burden worldwide. Accurate diagnosis is critical to ensure timely selection of treatment options. Matt Sause, CEO of Roche Diagnostics, said in a news release The manuscript states: “If left untreated, hepatitis B may lead to chronic infection, putting people at high risk of death from cirrhosis and liver cancer. “Our portfolio of viral hepatitis tests underscores Roche’s commitment to tackling the biggest challenges facing healthcare, supporting clinicians and their patients.”

The World Health Organization estimated that 296 million people were living with chronic hepatitis B in 2019, with 1.5 million new infections reported annually. Data for 2019 also showed that an estimated 820,000 people died from HBV-related deaths, mainly from cirrhosis and hepatocellular carcinoma.2

HBV is usually diagnosed by detecting active infection using the HBV surface antigen (HBsAg) test. The different types of antigens within HBsAg indicate the degree of infectivity. Patients infected with hepatitis Be antigen (HBeAg) carry higher viral loads. Acute or ongoing chronic infection is associated with anti-Bc hepatitis IgM.3

HBV surface antibodies contain viral DNA in blood and liver tissue and can be further analyzed using polymerase chain technology. People with hepatitis B may experience symptoms such as fever, fatigue, loss of appetite, nausea, and vomiting.

Research points to the importance of maintaining virus antibody levels. Interferon alpha (IFN-a), one of the only treatments for active hepatitis B virus infection, directly inactivates viral DNA by inhibiting protein synthesis.4 Hepatitis B is the most common type of viral hepatitis, affecting all ages and placing a significant burden on healthcare systems worldwide.1

According to Roche, the Elecsys HBeAg Quantitative Test complements current HBV detection markers. The test will allow caregivers to determine the stage of disease in patients with suspected infection, assess viral activity in the liver, and risk for progressive liver disease and hepatocellular carcinoma.

Roche notes that Elecsys HBeAg reduces complexity and improves operational efficiency due to more streamlined workflows for laboratory personnel. Roche said Elecsys HBeAg provides qualitative results that help diagnose patients with HBeAg, serve as an early marker of acute HBV, and can be indicative of chronic or active HBV. This will improve patient management and help develop the most appropriate treatment plan, they added.

The tool may also enable perinatal screening by monitoring response to antiviral treatment in patients with hepatitis B. Roche said this could help support the development of treatment plans tailored to each patient’s needs.

refer to

1. Roche expands its hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection. Roche. Press Releases. November 27, 2023. Accessed: November 28, 2023.

2. World Health Organization 2023. Hepatitis B fact sheet. See Accessed: November 28, 2023.

3. Gregorio, Germana V, et al. Viral hepatitis. National Center for Biotechnology Information, U.S. National Library of Medicine, 1995, Accessed: November 28, 2023.

4. Houglum JE (1983). Interferon: Mechanism of action and clinical value. clinical pharmacy, 2(1), 20–28. Accessed: November 28, 2023.

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