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Roche's Breakthrough Hepatitis B Test Revolutionizes Diagnosis and Monitoring


28 November 2023

Roche has announced a significant milestone for hepatitis B patients with the introduction of Elecsys HBeAg quant. This groundbreaking immunoassay not only detects the presence of hepatitis B e antigen (HBeAg) but also quantifies it in human serum and plasma. With the potential to revolutionize healthcare, this test promises to streamline diagnostics and enhance patient care for the nearly 300 million individuals worldwide affected by hepatitis B infections.

The Elecsys HBeAg quant test, now available for use on the cobas® e analysers in countries accepting the CE Mark, can provide both qualitative and quantitative measurements of the hepatitis B e antigen (HBeAg) in human serum and plasma. This dual capability makes it a game-changer for healthcare providers and patients alike.

Hepatitis B is a global health burden that affects people of all ages, leading to severe complications such as cirrhosis and liver cancer. Timely diagnosis and treatment are critical, and Roche's new immunoassay addresses these needs effectively.

One Test, Comprehensive Information

The Elecsys HBeAg quant immunoassay is a groundbreaking tool for both diagnosis and monitoring. This single test can determine not only the presence of HBeAg but also quantify it, providing insights into the extent of the hepatitis B infection. Clinicians can now assess a patient's disease phase, the activity of the virus in the liver, and the risk of progressive liver disease and hepatocellular carcinoma, all from a single test result.

Matt Sause, CEO of Roche Diagnostics, pointed out: “Hepatitis B affects millions of people each year and is a major global health burden. An accurate diagnosis is critical to ensuring timely treatment options. If hepatitis B is left untreated, it can cause chronic infections, putting people at high risk of death from cirrhosis and liver cancer. The addition of the Elecsys® HBeAg quant immunoassay to our viral hepatitis testing portfolio underlines Roche’s commitment to tackle healthcare’s biggest challenges to support clinicians and their patients.”

Streamlined Workflow and Patient Benefits

The Elecsys HBeAg quant test is not only a diagnostic marvel but also simplifies the healthcare process. It reduces complexity and improves operational efficiency for laboratory personnel. Patients benefit from the convenience of undergoing just one test to determine the presence and quantity of HBeAg.

The qualitative result from the test can identify HBeAg as an early marker of acute hepatitis B, as well as indicate chronic or active hepatitis B. The quantitative data enhances patient management, enabling the most suitable treatment plan to be tailored to individual needs.

Moreover, this innovative immunoassay serves multiple purposes, including perinatal screening and monitoring the response to antiviral treatment within infected patients. It empowers healthcare providers to craft personalized therapeutic plans that offer better outcomes for patients.

Expanding Diagnostics Portfolio

Roche's commitment to improving healthcare extends beyond hepatitis B. The company also offers a portfolio that includes a hepatitis E immunoassay, an automated version of the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections, and tests for diagnosing other conditions such as multiple sclerosis and neonatal sepsis.

In conclusion, Roche's Elecsys HBeAg quant immunoassay represents a significant advancement in the field of hepatitis B diagnostics and monitoring. With its ability to provide both qualitative and quantitative data, it promises to enhance patient care, streamline healthcare workflows, and contribute to the global effort to combat hepatitis B. As a crucial tool in the fight against this debilitating disease, its impact is poised to be substantial.

About the Elecsys HBeAg quant immunoassay

Elecsys® HBeAg quant is an immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma. In conjunction with other laboratory results and clinical information, HBeAg quantification may be used as an aid for the diagnosis and monitoring of patients with hepatitis B viral infection. Elecsys® HBeAg quant reports both a qualitative and a quantitative readout, providing greater value to clinicians and patients. The test can be used for samples from patients with unknown HBeAg status as well as those who have previously tested positive. The immunoassay is intended for use on all available cobas e analysers.


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