- It is estimated that one-third of the global population may be at risk of infection with the hepatitis E virus.1
- In line with recommendations from the European Association for the Study of the Liver (EASL), the new test enables clinicians to diagnose acute and chronic infections in patients with or without signs of disease.2
- Roche’s comprehensive range of tests is used for the differential diagnosis of acute viral hepatitis caused by hepatitis A, B, C and E viruses.
Basel, November 16, 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of Elecsys® Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of hepatitis E virus in various countries ( HEV) infection receives CE marking. By detecting HEV infection, clinicians can help patients determine the cause of symptoms and determine appropriate treatment, monitor the progression of severe acute HEV, and prevent severe disease progression with antiviral treatment.1,2,6
Recognizing the value of diagnostics, the World Health Organization (WHO) has developed a “List of Essential Diagnostics” that includes in vitro diagnostics that should be available in all countries to increase timely and life-saving diagnosis. For the first time this year, HEV testing is included to help diagnose and monitor HEV infection.5
“These tests underscore Roche’s commitment to contributing to the elimination of infectious diseases worldwide. HEV infection is a virus with significant global impact, causing 70,000 deaths and 3,000 stillbirths each year,”3,4 said Matt Soth, CEO of Roche Diagnostics. “The inclusion of anti-HEV IgM in the newly released WHO 2023 Essential Diagnostics List demonstrates the important role this test plays in disease management for patients around the world.
HEV testing can also help manage infected patients in high-risk groups and avoid misdiagnosis of drug-induced liver injury.1,2,6 They will also help to more accurately estimate the global HEV disease burden and inform governments and public health stakeholders on how to respond to the disease globally.5 As hybrid vehicles are under-reported, increasing these tests will support governments in managing the outbreak.
These fully automated tests will support laboratory staff, allowing them to run tests more efficiently than manual tests, as they require smaller sample volumes than manual tests, enabling results to be obtained in 18 minutes.
About Elecsys Anti-HEV IgM and Anti-HEV IgG Immunoassays
Elecsys Anti-HEV IgM is an in vitro immunoassay for the qualitative detection of HEV IgM antibodies in human serum and plasma. It can be used to assist in the detection of acute or recently acquired HEV infection. Elecsys Anti-HEV IgG is an immunoassay for the in vitro quantitative determination of IgG antibodies against HEV in human serum and plasma to aid in the detection of recent or past HEV infection.
The performance of both assays was evaluated in a multicenter study that tested a total of more than 8,900 samples from presumed acute and convalescent HEV infections to determine relative sensitivities, as well as from hospitalized Samples from patients, blood donors, and pregnant women to determine relative specificity relative to relative sensitivity.
The overall relative sensitivities of the Elecsys anti-HEV IgM and Elecsys anti-HEV IgG assays were determined to be 98.7% (95% CI 97.3 – 99.5%) and 99.1% (95% CI 98.0 – 99.7%), respectively. Overall specificity was determined to be 99.4% (95% CI 99.2 – 99.6%) and 99.8% (95% CI 99.6 – 99.9%), respectively.
The new test is available for the cobas® e 411 analyzer, the cobas e 601/602 modules and the cobas e 402 and cobas e 801 analysis modules. They expand Roche’s comprehensive portfolio of viral hepatitis serology tests and complete the portfolio of tests for the differential diagnosis of acute hepatitis caused by hepatitis A, B, C and E viruses (along with Elecsys Anti-HAV IgM , Elecsys Anti-HBc IgM, Elecsys HBsAg II, Elecsys Anti-HCV II and Elecsys HCV Duo tests).
related World Health Organization (WHO) 2023 Essential Diagnostic List (EDL)
The World Health Organization (WHO) 2023 Essential Diagnostics List (EDL) is an evidence-based register of in vitro diagnostics that supports countries in making national diagnostic choices.
The EDL is updated every two years and is designed to support the development of national in vitro diagnostics policy and improve access to IVD testing and clinical laboratory services. In addition to providing information to national EDLs, it also provides recommendations on IVD prioritization at different levels of the health care system. In addition, it provides information to United Nations agencies and non-governmental organizations that support the selection, procurement, supply or donation of IVDs, and provides guidance to the private medical technology and manufacturing sectors on IVD priorities needed to address global health problems.5
About hepatitis E virus (HEV)
HEV is a pathogen of growing global public health concern.7.8 HEV includes 8 genotypes, of which HEV-1 to 4 are the most commonly detected worldwide. HEV-1 and HEV-2 only infect humans, while HEV-3 and HEV-4 can infect humans and animals such as pigs, wild boars, rabbits and deer.9-15 HEV-1 and HEV-2 are estimated to cause approximately 20.1 million HEV infections, 3.4 million symptomatic cases, 70,000 deaths, and 3,000 stillbirths each year.3
HEV-1 and HEV-2 are commonly found in developing countries with poor sanitation, and HEV is transmitted via the fecal-oral route.7.1016 In developed countries, HEV-3 accounts for the majority of sporadic HEV infections, whereas HEV-4 is found mainly in Asia. Both HEV-3 and HEV-4 are transmitted zoonotically, most commonly through undercooked meat.7,17,18 Transfusion of HEV-3 and HEV-4 has occasionally been reported in some countries.7, 19,20
HEV infection typically results in mild or subclinical infection with self-limiting disease lasting 2 to 6 weeks.21, 22 Symptomatic hepatitis E is similar to other acute hepatitis infections (fatigue, nausea, vomiting, and jaundice and elevated liver enzymes).twenty one High-risk groups are immunocompromised patients (especially transplant recipients),22,21,23,24 Patients with underlying liver disease, the elderly and pregnant women.9,19,13,25-27
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 consecutive year, Roche has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Index, which fully reflects our efforts to pursue long-term development 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.
All trademarks used or mentioned in this press release are protected by law.
refer to
(1) Weber GW, Dalton HR. Hepatitis E: An underestimated emerging threat. Advanced infectious diseases. 2019;6:1-18
(2)EASL. Clinical practice guidelines for hepatitis E virus infection. J Liver 2018;68:1256-1271
(3) World Health Organization (WHO). Hepatitis E vaccine: World Health Organization position paper. Weekly Epidemiol Report 2015;18:185-200.
(4) Rein DB et al. Global burden of hepatitis E genotypes 1 and 2 in 2005. Hepatology. 2012;55:988-997.
(5) World Health Organization. WHO releases new essential diagnostic list; new recommendations on hepatitis E virus testing, personal use of blood glucose meters (Internet; updated October 19, 2023; cited on November 2, 2023).Available from https://www.who.int/news/item/19-10-2023-who-releases-new-list-of-essential-diagnostics–new-recommendations-for-hepatitis-e-virus-tests Get–Personal use blood glucose meter
(6)Ka·P, Kana·La. Review of diagnosis and treatment of hepatitis E. Current Treatment Options Infect Dis 2020;12:310–320
(7) Khuro MS et al. Hepatitis E: discovery, global impact, control and cure. World Journal of Gastroenterology. 2016;22:7030-7045.
(8) Weber GW, Dalton HR. Hepatitis E: An underestimated emerging threat. Advanced infectious diseases. 2019;6:2049936119837162.
(9) Li Ping, et al. Global epidemiology of hepatitis E virus infection: a systematic review and meta-analysis. Liver Int 2020;40(7):1516-1528.
(10) Goel A, Aggarwal R. Hepatitis E: epidemiology, clinical course, prevention, and treatment. Gastroenterol Clin North Am 2020;49:315-330.
(11) Yeraghi et al. Hepatitis E virus: an emerging enigmatic and underappreciated pathogen. Saudi J Biol Sci 2022;29:499-512.
(12) Kamar N et al. Hepatitis E Lancet. 2012;379:2477-2488.
(13) Aggarwal R, Goel A. Natural history, clinical manifestations, and pathogenesis of hepatitis E virus genotype 1 and 2 infection. Cold Spring Harbor Perspective Med. 2019;9:a032136.
(14) Smith DB et al. Update: Proposed reference sequences for hepatitis E virus subtypes (orthohepatitis A virus). J Gen Virol. 2020;101:692-698.
(15) Purdy MA et al. ICTV virus taxonomy overview: Hepaciviridae. 2022. Journal of Modern Viruses 2022;103(9).
(16) Ruggeri FM et al. Zoonotic transmission of hepatitis E virus in industrialized countries. New microorganisms. 2013;36:331-44.
(17) Izopet J et al. Hepatitis E virus infection in Europe. J Clin Virol. 2019;120:20-26.
(18) World Health Organization. Hepatitis E fact sheet. Last updated June 2022 (Internet, updated July 2023, cited on July 24, 2023). URL: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.
(19) Al-Sadeq DW et al. Laboratory challenges in hepatitis E virus diagnosis. Journal of Medical Microbiology. 2018;67(4):466-480.
(20) Pérez-Gracia MT et al. Hepatitis E: an emerging disease. Infectious gene evolution. 2014;22:40-59.
(21) Kamar N et al. Hepatitis E virus infection. Nat Rev Dis Primer. 2017;3:17086.
(22) Lhomme S et al. Pathogenesis of hepatitis E. Virus. 2016;8:212.
(23) Lalu H et al. Hepatitis E, what’s the real problem? J Liver Int 2020;40(Suppl 1):43-47.
(24) Lhomme S et al. Zoonotic risk of HEV transmission by rabbits. J Clin Virol. 2013;58:357-362.
(25) Zhao Q, et al. Antigenic determinants of hepatitis E virus and vaccine-induced immunogenicity and efficacy. J Gastroenterology. 2013;48:159-168.
(26) Aggarwal R. Hepatitis E: clinical manifestations and diagnosis in endemic areas. Semin liver disease. 2013;33:30-40.
(27) Velavan TP et al. Hepatitis E: One Health and recent advances in clinical medicine. Liver Int 2021;41:1462-1473.
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16112013_MR_Launch of Elecsys anti-HEV IgM and anti-HEV IgG_en
