Viral hepatitis

Viral hepatitis accounts for 1.34 million deaths globally—including liver cancer, acute cases, and cirrhosis³—and exceeded the number of deaths caused by HIV infection, tuberculosis, or malaria in 2018.³ By 2040, deaths from chronic hepatitis are expected to exceed the combined mortality associated with HIV, tuberculosis, and malaria.³

Types of hepatitis

Hepatitis A (HAV) virus

Hepatitis A is a liver inflammation caused by the hepatitis A virus (HAV), transmitted through contaminated food, water, or direct contact. Most recover fully with lifelong immunity, but a small proportion can develop severe complications. Risk factors include poor water quality and hygiene. In 2016, WHO estimated over 7,000 persons died from hepatitis A worldwide (accounting for 0.5% of the mortality due to viral hepatitis). Vaccination is effective for prevention.⁴

Viral hepatitis is a major public health threat and a leading cause of death worldwide. Diagnostics and effective testing strategies are crucial in curbing the hepatitis burden. However, there are major gaps in testing and treatment, specifically among economically disadvantaged regions, rural and displaced populations, and at-risk groups.

The World Health Organization (WHO) estimated 4.5 million premature deaths could be prevented in low- and middle-income countries by 2030 through the use of vaccination, diagnostic tests, medicines, and education campaigns for hepatitis.⁹ For the most affected populations, testing and treatment remain beyond reach.

Elimination goals

In response to the global burden of hepatitis, the World Health Assembly approved WHO's global hepatitis strategy in 2016. This strategy aims for the global elimination of viral hepatitis by 2030, setting targets of achieving a 90% reduction in new cases and a 65% reduction in deaths.⁹

Early detection, confirmation of active infection, and viral load monitoring for HCV infections are crucial diagnostic steps to allow treatment, prevent or delay disease progression, and effectively disrupt virus transmission.

Roche’s HCV assays offers:

• In vitro qualitative detection of antibodies to HCV and HCV antigens in serum and plasma¹¹
• Single specimen testing that increases convenience and reduces the number of clinic visits that a patient needs to make¹²
• High sensitivity for early PCR detection of infection, with 100% sensitivity for different stages of HCV infection¹¹
• Detection of all clinically relevant HCV genotypes that allows testing relevant for all geographical regions₁₃
• Significant shortening of the diagnostic window period by up to 3 weeks compared with traditional testing regimens¹⁴

Roche Diagnostics offers a comprehensive solution for Hepatitis B infection. Our CE- and FDA-marked portfolio enhance laboratory efficiency and patient management. With low sample volume requirements and fast turnaround time, you can obtain accurate results quickly.

Our assays provide excellent coverage for genotypes and mutants, ensuring precise diagnosis and monitoring.^17,18 They also offer high sensitivity for seroconversion.¹⁹ Our first-line screening assays have excellent specificity, reducing the need for confirmatory testing. Ready-to-use reagents and advanced technologies further streamline your workflow.

Overall, our HBV Portfolio provides high-performance diagnostic markers for optimal screening, diagnosis, and therapy monitoring of Hepatitis B.

While HEV infection often remains asymptomatic and viral clearance typically occurs spontaneously in most cases, it can pose severe risks for individuals with certain predisposing risk factors, such as underlying chronic liver disease, pregnancy, and immunocompromised states, leading to potentially fatal outcomes like severe hepatitis and liver failure.²⁰

To bridge this diagnostic gap, we offer highly reliable automated serology assays designed to detect both acute and past HEV infections, as well as to screen blood donors for potential transmission. Our anti-HEV assays are designed for the highly sensitive and specific detection of HEV infection, facilitating:

• Diagnosis of acute or recently acquired HEV infection
• Differential diagnosis of acute hepatitis
• Assessment of HEV immunity status
• Evaluation of the risk of HEV reinfection
• Detection of emerging zoonotic pathogens in donor blood to mitigate the risk of transfusion transmission²¹

Diagnostic testing for HAV infection is a critical tool in the differential diagnosis of viral hepatitis as hepatitis A cannot be differentiated from other types of viral hepatitis on the basis of clinical features alone. Serology testing for HAV is an essential component of clinical diagnosis, disease prevention, and public health management. Roche offers a serology test panel for confirmation of infection and immunity/vaccination verification.^22,23

• Diagnosis of acute or recently acquired HAV infection
• Differential diagnosis of acute hepatitis
• Assessment of HAV immunity status
• Detection of HAV in donor blood to mitigate the risk of transmission via blood products.

With the increasing complexity, breadth, and volume of infectious disease testing, labs want a long-term, collaborative partner that understands their needs and helps them build a lab that delivers the best possible service, both pre- and post-sale. Roche offers strategic partnerships, acting as a trusted ally to healthcare providers by:

• Anticipating and supporting all phases of lab operations to ensure optimal performance and continuous improvement through our Roche 360° Service Solutions
• Providing expert consultancy to optimize the integration of data and resources
• Continuous investment in innovative solutions to ensure we meet evolving healthcare needs
• Offering tailored solutions through a broad range of products, integration, and automation to help our customers reach operational excellence