Roche launches automated serology hepatitis E virus tests,
including a test to detect acute HEV infections, recommended in the
new WHO 2023 Essential Diagnostics List
- It is estimated that one
third of the global population could be at risk for infection with
Hepatitis E virus.1
- The new tests allow
clinicians to diagnose acute and chronic infections amongst
patients presenting with or without signs of the illness as
recommended by the European Association for the Study of the Liver
(EASL).2
- The tests complete Roche’s
panel used for the differential diagnosis of acute viral hepatitis
caused by the hepatitis A, B, C and E viruses.
Basel, 16 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the launch of the Elecsys®Anti-HEV IgM and Elecsys
Anti-HEV IgG immunoassays for the detection of hepatitis E virus
(HEV) infections in countries accepting the CE mark. By testing for
HEV infection, clinicians can support their patients to identify
the cause of their symptoms and determine appropriate treatment,
monitor for progression to severe acute HEV and prevent severe
disease progression with antiviral treatment.1,2,6
Recognising the value of diagnostics, the World Health
Organization (WHO) has developed an “Essential Diagnostics List”
which includes in-vitro diagnostics that should be available in all
countries to increase timely and life-saving diagnoses. This year
for the first time, tests for HEV are included to aid in the
diagnosis and surveillance of HEV infection.5
“These tests highlight Roche’s commitment to contributing to the
elimination of infectious diseases globally. Infection with HEV, a
virus of significant global impact, results in 70,000 deaths and
3,000 stillbirths annually,”3,4 said Matt Sause, CEO of Roche
Diagnostics. “The Anti-HEV IgM inclusion in the newly released WHO
2023 Essential Diagnostics List, demonstrates the important role
this test plays in disease management for patients globally.
HEV testing also contributes to managing infected patients in
high-risk groups and avoiding the misdiagnosis of drug-induced
liver injury.1,2,6 They will also help to provide a more accurate
estimate of the global HEV disease burden and inform governments
and public health stakeholders on how to respond to the disease
globally.5 As HEV is under-reported, the addition of these tests
will support governments in managing outbreaks.
These fully automated assays will support lab personnel by
enabling them to run them more efficiently compared to manual
tests, as they require smaller sample volumes than manual tests,
enabling results to be available within 18 minutes.
About the Elecsys Anti-HEV IgM and Anti-HEV IgG
immunoassaysElecsys Anti-HEV IgM is an immunoassay for the
in vitro qualitative detection of IgM antibodies to HEV in human
serum and plasma, and is used as an aid to detect an acute or
recently acquired HEV infection. Elecsys Anti-HEV IgG is an
immunoassay for the in vitro quantitative determination of IgG
antibodies to HEV in human serum and plasma, and is used as an aid
to detect a recent or past HEV infection.
The performance of both assays was evaluated in a multi-center
study, which tested a total of more than 8,900 samples from
presumed acute and recovered HEV infection for the determination of
relative sensitivity, and from hospitalized patients, blood donors
and pregnant women for the determination of relative
specificity.
The overall relative sensitivity of the Elecsys Anti-HEV IgM and
Elecsys Anti-HEV IgG assay was determined as 98.7% (95% CI 97.3 –
99.5%) and 99.1% (95% CI 98.0 – 99.7%), respectively. The overall
specificity was determined as 99.4% (95% CI 99.2 – 99.6%) and 99.8%
(95% CI 99.6 – 99.9%), respectively.
The new assays are available for use on the cobas® e 411
analyzer, cobas e 601/602 modules, and the cobas e 402 and cobas e
801 analytical modules. They expand Roche’s comprehensive viral
hepatitis serology test portfolio, and complete the test panel used
for the differential diagnosis of acute hepatitis caused by the
hepatitis A, B, C and E viruses (alongside the Elecsys Anti-HAV
IgM, Elecsys Anti-HBc IgM, Elecsys HBsAg II, Elecsys Anti-HCV II,
and Elecsys HCV Duo assays).
About the World Health Organisation’s
(WHO) 2023 Essential Diagnostics List (EDL)The World
Health Organisation’s (WHO) 2023 Essential Diagnostics List (EDL)
is an evidence-based register of in vitro diagnostics that supports
countries to make national diagnostic choices.
Updated biennially, the EDL is intended to support national in
vitro diagnostics policy development and to improve access to IVD
testing and clinical laboratory services. As well as informing
national EDLs, it provides advice on prioritization of IVDs at
different levels of the healthcare system. Additionally, it informs
United Nations agencies and non-government organizations that
support the selection, procurement, supply or donation of In Vitro
Diagnostics along with guidance to the private health technology
and manufacturing sectors about the IVDs priorities required to
address global health issues.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 frequently detected
globally. HEV-1 and HEV-2 infect only humans, whereas HEV-3 and
HEV-4 can infect both humans and animals such as pigs, wild boar,
rabbits and deer.9-15 It is estimated that HEV-1 and HEV-2 account
for approximately 20.1 million HEV infections, 3.4 million
symptomatic cases, 70,000 deaths, and 3000 stillbirths
annually.3
HEV-1 and HEV-2 are commonly found in developing countries with
poor sanitation, where HEV is transmitted through the fecal-oral
route.7,10, 16 HEV-3 accounts for most of the sporadic HEV
infections in developed countries while HEV-4 is mainly found in
Asia. Both HEV-3 and HEV-4 are transmitted zoonotically, most
commonly through undercooked meat.7,17,18 In several countries,
occasional transmission of HEV-3 and HEV-4 through blood
transfusion has been reported.7, 19,20
HEV infection usually causes a mild or subclinical infection
with a self-limiting illness that lasts from 2 to 6 weeks.21, 22
Symptomatic hepatitis E is similar to other acute hepatitis
infections (fatigue, nausea, vomiting as well as jaundice and
elevated liver enzymes).21 High-risk populations are
immunocompromised patients (specifically transplant organ
recipients),22,21,23,24 patients with underlying liver conditions,
and elderly people and pregnant women.9,19,13,25-27
About Roche Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] Webb GW, Dalton HR. Hepatitis
E: an underestimated emerging threat. Ther Adv Infect Dis.
2019;6:1-18[2]EASL. Clinical Practice Guidelines on hepatitis E
virus infection. J Hepatol 2018;68:1256-1271[3] World Health
Organization (WHO). Hepatitis E vaccine: WHO position
paper. Wkly Epidemiol Rec. 2015;18:185-200.[4] Rein DB,
et al. The global burden of hepatitis E genotypes 1 and 2 in 2005.
Hepatology. 2012;55:988-997.[5] World Health Organization. WHO
releases new list of essential diagnostics; new recommendations for
hepatitis E virus tests, personal use glucose meters [Internet;
updated 2023 Oct 19; cited Nov 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--personal-use-glucose-meters[6]
Kar P, Karna RA. A Review of the Diagnosis and Management of
Hepatitis E. Curr Treat Options Infect Dis 2020;12:310–320[7]
Khuroo MS, et al. Hepatitis E: Discovery, global impact, control
and cure. World J Gastroenterol. 2016;22:7030-7045.[8] Webb GW,
Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv
Infect Dis. 2019;6:2049936119837162.[9] Li P, et al. The 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]
Raji YE, et al. Hepatitis E Virus: An emerging enigmatic and
underestimated 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 Infections. Cold
Spring Harb Perspect Med. 2019;9:a032136.[14] Smith DB, et al.
Update: proposed reference sequences for subtypes of hepatitis E
virus (species Orthohepevirus A). J Gen Virol.
2020;101:692-698.[15] Purdy MA, et al. ICTV Virus Taxonomy Profile:
Hepeviridae. 2022. J Gen Virol 2022;103(9).[16] Ruggeri FM, et al.
Zoonotic transmission of hepatitis E virus in industrialized
countries. New Microbiol. 2013;36:331-44.[17] Izopet J, et al.
Hepatitis E virus infections in Europe. J Clin Virol.
2019;120:20-26.[18] World Health Organisation. Factsheet Hepatitis
E. Last updated June 2022 [Internet, updated 2023 July, cited 2023
July 24]. Available at:
https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.[19]
Al-Sadeq DW, et al. Laboratory challenges in the diagnosis of
hepatitis E virus. J Med Microbiol. 2018;67(4):466-480.[20]
Pérez-Gracia MT, et al. Hepatitis E: an emerging disease. Infect
Genet Evol. 2014;22:40-59.[21] Kamar N, et al. Hepatitis E virus
infection. Nat Rev Dis Primers. 2017;3:17086.[22] Lhomme S, et al.
Hepatitis E Pathogenesis. Viruses. 2016;8:212.[23] Larrue H, et al.
Hepatitis E, what’s the real issue? Liver Int. 2020;40(Suppl
1):43-47.[24] Lhomme S, et al. Risk of zoonotic transmission of HEV
from 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 Gastroenterol. 2013;48:159-168.[26]
Aggarwal R. Hepatitis E: clinical presentation in disease-endemic
areas and diagnosis. Semin Liver Dis. 2013;33:30-40.[27] Velavan
TP, et al. Hepatitis E: An update on One Health and clinical
medicine. Liver Int 2021;41:1462-1473.
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- 16112013_MR_Launch of Elecsys Anti-HEV IgM & Anti-HEV
IgG_en
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