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Viral Hepatitis

Reliable, scalable, and sustainable diagnostic solutions to help support the management and eradication of viral hepatitis

Shining a light on viral hepatitis

Benefits of Roche diagnostic and management solutions for viral hepatitis

A comprehensive testing solution

The right hepatitis diagnostic portfolio offers a broad range of tools that address key population needs from increasing accessibility to decreasing the number of patients lost to follow-up and beyond. Roche’s comprehensive hepatitis diagnostic portfolio offers powerful tools designed to address key population needs and support the objectives outlined in WHO's global hepatitis strategy. With our solutions, healthcare providers have the capability to:

  • Assess liver function with enzyme testing
  • Screen and diagnose with immunoassays
  • Monitor disease progression with immunoassays
  • Use reliable diagnostic solutions for HAV, HBV, HCV, and HEV infections
  • Determine HCV genotype
  • Monitor viral load to assess HBV and HCV treatment response
  • Test for hepatocellular carcinoma (HCC) biomarkers

HCV diagnosis through innovation

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

Delivering optimal HBV results

Roche Diagnostics offers a comprehensive solution for Hepatitis B infection, offering enhanced 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.16 They also offer high sensitivity for seroconversion.18 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.

Closing the HEV diagnostic gap

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.19

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

The right tests to support diagnostic best practice

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.20,21

  • 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

Comprehensive solution portfolio and partnership for enhanced value

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 optimise 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
An illustration of a group of people in the park that are affected by a range of infectious diseases

Whitepaper: Current capabilities and shortcomings of Hepatitis E virus (HEV) diagnosis

Download our complimentary whitepaper offering an in-depth exploration into HEV virology and epidemiology, available diagnostic approaches for HEV infection, and opportunities for enhancing diagnostic tools.

An illustration of a group of people in the park that are affected by a range of infectious diseases

Interactive infectious diseases testing guide

Unlock insights with our interactive infectious diseases testing guide and take some of the world’s most notorious infectious agents to the test. Discover pathogen-specific markers, examine comprehensive testing algorithms, and simulate diagnostic sequences.

References

  1. World Health Organization. Global Hepatitis Report 2024 [Internet; updated 2024 Apr 9; cited 2024 May 08]. Available from: https://www.who.int/publications/i/item/9789240091672.
  2. Cooke GS et al. Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2019;4(2):135-184.
  3. Thomas DL. Global elimination of chronic hepatitis. N Engl J Med. 2019;380:2041-2050.
  4. World Health Organization. Hepatitis A Key Facts [Internet; cited 2024 May 8]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-a.
  5. World Health Organization. Hepatitis B Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.
  6. World Health Organization. Hepatitis C Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c.
  7. World Health Organization. Hepatitis D Key Facts [Internet; cited 2024 May 8]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-d.
  8. World Health Organization. Hepatitis E Key Facts [Internet; cited 2024 April 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.
  9. World Health Organization. Hepatitis [Internet; cited 2024 April 5]. Available from: https://www.who.int/health-topics/hepatitis/elimination-of-hepatitis-by-2030.
  10. CDA Foundation. HCV Elimination Targets [Internet; cited 2024 April 5]. Available from: https://cdafound.org/dashboard/polaris/maps.html.
  11. Elecsys® Anti-HCV II Mat. Nos. 08836981190 & 08837031190: V2.0, 2024-04; Mat. No. 08837058190: V1.0, 2023-09.
  12. Elecsys® HCV Duo (Mat. No. 08110697190) method sheet, V3.0 2023-03.
  13. cobas® HCV Test. Method Sheet. 09198865001-05EN  Doc Rev. 5.0  57
  14. Majchrzak M et al (2022). Multicenter performance evaluation of the Elecsys HCV Duo immunoassay. J. Clin. Virol;156:105293.
  15. World Health Organization (WHO).  https://www.who.int/news-room/fact-sheets/detail/hepatitis-d#:~:text=HDV%20infection%20occurs%20when%20people,B%20(super%2Dinfection).  Accessed 28May2024
  16. cobas HBV, Quantitative nucleic acid test for use on the cobas 5800/6800/8800 Systems - CE-IVD.  Instructions for Use.  09040820190-03EN Doc  Rev.  3.0
  17. Elecsys Anti-HBe. Instructions for Use.  11820613500 V18.0
  18. World Health Organization (WHO).  https://www.who.int/news-room/fact-sheets/detail/hepatitis-d#:~:text=HDV%20infection%20occurs%20when%20people,B%20(super%2Dinfection).  Accessed 28May2024
  19. Elecsys® Anti-HEV IgM. Material Numbers 09056246190 and 09056254190, Method Sheet 2023-09, V1.0.
  20. Elecsys® Anti-HAV IgM method sheet, V17.0 2022-06.
  21. Elecsys® Anti-HAV II method sheet, V3.0 2022-03.