- The Elecsys® HBeAg Quantification is an immunoassay that can be used as an early marker of acute hepatitis B infection or as an indicator of chronic active hepatitis in combination with other laboratory results and clinical information.
- A single test will inform clinicians whether treatment is needed and whether treatment options should be combined with other diagnostic tests.
- Nearly 300 million people worldwide live with chronic hepatitis B, which places a heavy burden on health systems as it puts patients at high risk of death from cirrhosis and liver cancer.1
Basel, November 27, 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of Elecsys® HBeAg Quant, an immunoassay capable of determining the presence and amount of hepatitis B e (qualitative and quantification) of antigen (HBeAg) in human serum and plasma. The launch means that, combined with other laboratory results and clinical information, patients will now be able to confirm whether they have hepatitis B (HBV), and if so, to what extent, and monitor their treatment with a single test. It is suitable for cobas® e analyzers in countries that accept the CE mark. Hepatitis B is the most common type of viral hepatitis, affecting people of all ages and placing a heavy burden on people and health care systems worldwide.1
The new Elecsys HBeAg quantitative test will complement existing HBV detection markers. When a patient with suspected HBV tests positive for HBeAg, clinicians can determine the patient’s disease stage,twenty three Assessing viral activity in the liver4 and the risk of progressive liver disease and hepatocellular carcinoma (HCC).5.6
“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. If hepatitis B is not treated promptly, it will It can lead to chronic infections, putting people at high risk of death from cirrhosis and liver cancer. “The test portfolio underscores Roche’s commitment to solving healthcare’s biggest challenges and supporting clinicians and their patients.”
New diagnostic tools reduce complexity and improve operational efficiency as laboratory personnel have more streamlined workflows. It also simplifies the patient experience as they only need to undergo one test that indicates the presence and amount of HBeAg. The test provides qualitative results that can help diagnose patients with HBeAg, serve as an early marker of acute HBV, and indicate chronic or active HBV. Additional quantitative answers will enhance patient management by providing patients with the most appropriate treatment plan.
Elecsys HBeAg Quantification can also be used as a perinatal screening tool7 Monitoring antiviral treatment response in infected patients may support implementation of treatment plans tailored to individual patient needs.
About Elecsys HBeAg Quantitative Immunoassay
Elecsys® HBeAg Quant is an immunoassay for the qualitative and quantitative in vitro determination of hepatitis B e antigen (HBeAg) in human serum and plasma. Combined with other laboratory results and clinical information, HBeAg quantification can aid in the diagnosis and monitoring of patients with hepatitis B virus infection. Elecsys® HBeAg Quantitative reports both qualitative and quantitative readings, providing greater value to clinicians and patients. The test can be used on samples from patients whose HBeAg status is unknown (first-line testing) as well as from patients who have previously tested positive (second-line testing). Immunoassays are available on all available cobas e analyzers.
About hepatitis B
Hepatitis B virus is a viral infection that attacks the liver and can cause acute and chronic illness.1 It is the most common type of viral hepatitis, affecting people of all ages and placing a heavy burden on people and health care systems worldwide.1 In 2019, the World Health Organization estimated that 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections every year. That same year, hepatitis B caused an estimated 820,000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). The virus is most commonly spread from mother to child during birth and delivery, and through contact with blood or other body fluids during sex with an infected partner, unsafe injections, or contact with sharp instruments.1 While there is a vaccine to prevent hepatitis B, there is currently no cure for people diagnosed with hepatitis B.
About Roche
Founded in Basel, Switzerland, in 1896, Roche was one of the earliest industrial manufacturers of branded pharmaceuticals and has grown into the world’s largest biotechnology company and a global leader in in vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics to improve and save lives around the world. We are pioneers in personalized healthcare and want to further transform the way healthcare is delivered to make an even greater impact. To provide the best care for everyone, we collaborate with many stakeholders and combine our strengths in diagnostics and pharmaceuticals with data insights from clinical practice.
For the thirteenth year in a row, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Index, a recognition of the long-term growth we strive for in everything we do. This distinction also reflects our efforts to improve access to health care with local partners in each country where we work.
Genentech is a wholly-owned subsidiary of the Roche Group. Roche is the majority shareholder of Chugai Pharmaceuticals in Japan.
For more information, please visit Roche.
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refer to
(1) World Health Organization 2023. Hepatitis B fact sheet. allowable: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-bdate of access: April 2023
(2)EASL2017. J Liver 2017;67:370–398.
(3) Huang Guangli et al. Clin Infect Dis 2016;62(Suppl 4):S298–S305.
(4) Fletcher GJ et al. J Clin Lab Analyst 2016;30:1146–1149.
(5) World Health Organization. 2017. https://www.who.int/hepatitis/publications/guidelines-hepatitis-cb-testing/en/
(6) Yang Hai et al. New England Journal of Medicine 2002;347:168–174.
(7) Mixson-Hayden T et al. J Clin Virol 2018;109:22–28.
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