Comprehensive Overview of Hepatitis E Diagnostics: Symptoms, Methods, Advancements

Every year, there are around 20 million hepatitis E (HEV) infections worldwide, which result in about 3.3 million symptomatic cases and 70,000 deaths, according to the World Health Organization (WHO). The virus is a major cause of human diseases in countries such as China and India, as well as in developing nations with remote settings and a lack of resources.

There is a critical need for effective management of hepatitis E diagnosis as the treatment options are still limited in various regions. This blog provides an overview of hepatitis E diagnostic tests and regional developments driving hepatitis E diagnostic tests market growth.

About Hepatitis E Virus

Hepatitis E is a virus that causes liver inflammation and damage. The disease is common in many regions of the world with a lack of clean water, poor sanitation and hygiene, and health services. In some cases, it can take a few months for a patient to recover from this disease, while it could be dangerous for pregnant women or people with compromised immune systems.

Transmission

Hepatitis E is transmitted via the fecal-oral route, mainly through drinking contaminated water. Even microscopic amounts of ingestion of the virus can cause symptoms. HEV can also be transmitted through contaminated food and the environment. One can develop HEV by consuming raw shellfish from contaminated water.

What are Symptoms?

Many people might not exhibit any symptoms. However, some can develop symptoms 15 to 60 days after infection. These symptoms may include:

Early Symptoms: Fever, body aches, fatigue, nausea, and vomiting

Chronic Symptoms: Belly pain, dark pee, Light-colored poop, Skin rash or itching, yellowish skin or eyes

What are Screening and Diagnostic Methods for Chronic HEV Infection?

ELISA - HEV IgM Test

Enzyme Immunoassay (ELISA) – HEV Immunoglobulin M (IgM) test detects the presence of IgM antibodies to the Hepatitis E Virus in human plasma and sera. IgM antibodies are usually found during the acute phase of the infection. Due to its reliability and cost-effectiveness, many health professionals across developing regions use the HEV IgM test for identifying recent or ongoing infections. As a result, in 2023, the ELISA HEV IgM Test segment held the largest market share in the hepatitis E diagnostic tests market.

ELISA HEV IgG Test

Enzyme ImmunoAssay (ELISA) – HEV Immunoglobulin G (IgG) test is intended for the detection of Immunoglobulin G (IgG) antibodies against HEV. It’s a screening test that often involves repeat testing of initially reactive specimens. A patient with initial symptoms or a history of HEV infection or a resolved infection can develop IgG antibodies. The presence of IgG may also indicate long-term immunity.

For instance, in November 2023, F. Hoffmann-La Roche AG, commonly known as Roche, a Swiss-based healthcare company, launched the automated Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays to diagnose acute and chronic hepatitis E virus (HEV). Clinicians can identify the cause of symptoms, determine accurate treatment, and prevent long-term effects in patients with chronic HEV infection. The tests are limited to CE mark-accepting countries such as the European Union countries.

WHO Adds HEV Tests To 2023 EDL List?

The World Health Organization (WHO) included a rapid test for HEV in its 2023 Essential Diagnostics List (EDL), a compilation of in vitro diagnostics (IVDs) that support countries in developing their national diagnostic strategies. As HEV is a significant global health problem, the WHO has suggested the use of nucleic acid tests (NATs) like PCR assays for diagnosing acute HEV infections. One of the added PCR tests in the EDL is the Altona RealStar HEV RT-PCR assay, a real-time PCR technology capable of detecting hepatitis E virus (HEV) specific RNA.

RT-PCR for Rapid Detection of Hepatitis E Virus

Reverse transcriptase polymerase chain reaction (RT-PCR), which is a variant of PCR, can detect the hepatitis E virus RNA in the blood and stool of a patient. It is a highly sensitive and precise diagnosis test and can detect even minor levels of viral RNA in chronic patients or those with immune system disorders. The well-established healthcare infrastructure in both developed and developing regions, including specialized laboratories, hospitals, and research centers, fuels the growth of the RT-PCR segment. Additionally, the rising focus on early disease detection fuels the demand for RT-PCR in the hepatitis e diagnostic landscape.

Treatment

Is there any vaccine to prevent the hepatitis E virus? The answer is No. Additionally, there is no specific treatment available for acute hepatitis E. In mild cases, hospitalization may also not be required, as this disease usually goes away on its own in about 4-6 weeks. Hospitalization may be required for chronic HEV cases and pregnant women.

Using AI and ML for Hepatitis E Infection

Technologies like artificial intelligence (AI) and machine learning (ML) are coming as a transformative trend in the hepatitis e diagnostic tests market. These technologies can facilitate early, accurate, and efficient diagnosis, thereby improving patient outcomes, which may not be possible by conventional diagnostic methods. In addition, disease progression can be predicted through AI-driven diagnostics. More research is needed in AI-based hepatitis e-diagnostic tests, which could focus on developing advanced algorithms for integrating AI with rapid diagnostic platforms.

Some of The Companies in The Global Hepatitis E Diagnostic Tests Market Include:

• Abbott Laboratories
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers
• Bio-Rad Laboratories
• Thermo Fisher Scientific
• DiaSorin S.p.A.
• Perkin Elmer Inc.
• QIAGEN N.V.4
• Merck KGaA
• Ortho Clinical Diagnostics
• InBios International
• Altona Diagnostics

Why Hepatitis E Diagnostic Tests Market is Thriving in Asia Pacific and Europe

The market for hepatitis E diagnostic tests is growing in Europe owing to the escalated disease existence, especially in nations including Germany, France, and the UK. Favorable government support for disease monitoring, along with a robust regulatory structure for diagnostic testing, elevates the market growth in Europe. Additionally, various partnerships between public health institutions and private companies for better diagnosis solutions contribute to industry expansion.

Further, due to the high disease prevalence and well-developed healthcare systems in countries like China, India, and Japan, the Asia Pacific hepatitis E diagnostic tests market is growing at the fastest rate. In spite of economic hardship, factors like rising awareness and healthcare enhancements are fostering market growth in Latin America, particularly in Brazil and Mexico. Thus, the market shows moderate growth in Latin America.

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