Roche launches automated serology hepatitis E virus tests

Roche has launched the new 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.

Recognising the value of diagnostics, the World Health Organization (WHO) has recently updated its Essential Diagnostics List. This year for the first time, tests for HEV are included to aid in the diagnosis and surveillance of HEV infection.

“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.”

HEV testing also contributes to managing infected patients in high-risk groups and avoiding the misdiagnosis of drug-induced liver injury. 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. As HEV is under-reported, the addition of these tests will support governments in managing outbreaks.

These fully automated assays will support laboratory 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.

Elecsys 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-centre 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 hospitalised patients, blood donors and pregnant women for the determination of relative specificity.

The new assays are available for use on the cobas e 411 analyser, 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).


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