Automated Serology Tests Diagnose Hepatitis E Virus Infection in Symptomatic and Asymptomatic Patients

An estimated one-third of the world's population is potentially at risk of contracting Hepatitis E virus (HEV) infection. In response to this global health concern, the World Health Organization (WHO) has introduced HEV testing to its “Essential Diagnostics List,” recognizing the importance of these diagnostics for timely and potentially life-saving diagnoses. This inclusion marks a significant step in enhancing the detection and monitoring of HEV infections. Now, a new pair of tests allows clinicians to diagnose both acute and chronic HEV infections in patients with or without symptoms, in line with recommendations from the European Association for the Study of the Liver (EASL).

Roche (Basel, Switzerland) has launched the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for the detection of HEV infections in countries accepting the CE mark. The Elecsys Anti-HEV IgM immunoassay is designed for the qualitative in vitro detection of IgM antibodies to HEV in human serum and plasma, aiding in the identification of acute or recently contracted HEV infections. Similarly, the Elecsys Anti-HEV IgG immunoassay quantitatively determines IgG antibodies to HEV in human serum and plasma, assisting in recognizing recent or past HEV infections. These tests play a crucial role in helping clinicians pinpoint the cause of patient symptoms, enabling appropriate treatment, monitoring progress toward severe acute HEV, and preventing the escalation of the disease with antiviral therapy.

The effectiveness of both assays was validated through a comprehensive multi-center study involving over 8,900 samples. These samples, drawn from individuals presumed to have acute or recovered from HEV infection, hospital patients, blood donors, and pregnant women, were tested to gauge the assays' relative sensitivity and specificity. The Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG assays demonstrated high overall relative sensitivity rates of 98.7% and 99.1%, respectively, with similarly impressive specificity rates of 99.4% for IgM and 99.8% for IgG. The assays offer significant advantages for laboratory operations, being fully automated and more efficient than manual testing. They require smaller sample volumes and deliver results in as little as 18 minutes. These new tests are compatible with several analytical modules, including the cobas e 411 analyzer, cobas e 601/602 modules, and the cobas e 402 and cobas e 801 analytical modules.

“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,” 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.”

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