The Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG tests are intended for in-vitro qualitative detection of IgM antibodies and IgG antibodies to HEV respectively, in human serum and plasma to help detect acute, recently acquired or past HEV infections
Roche has introduced the Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays to detect hepatitis E virus (HEV) infections, in countries that accept the CE mark.
The Elecsys Anti-HEV IgM is designed for in-vitro qualitative detection of IgM antibodies to HEV in human serum and plasma, to help detect an acute or recently acquired HEV infection.
Its Elecsys Anti-HEV IgG is intended for the in vitro quantitative determination of IgG antibodies to HEV in human serum and plasma, to help detect a recent or past HEV infection.
Both are fully automated assays and provide results within 18 minutes.
The World Health Organization (WHO) has developed an ‘Essential Diagnostics List’ comprising necessary in-vitro diagnostics to ensure timely and life-saving diagnoses in all countries.
The Swiss healthcare company said that its HEV tests have been added to the list for the first time this year, to aid the diagnosis and surveillance of HEV infection.
Roche Diagnostics CEO Matt Sause said: “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.
“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.”
The testing for HEV infection would help clinicians identify the symptoms of their patients, determine appropriate treatment, and monitor and prevent its progression to severe disease.
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.
Roche said that its two new HEV tests require smaller sample volumes than manual tests and help lab personnel run them more effectively compared to manual tests.
Both assays were evaluated in a multi-centre study of more than 8,900 samples from people with suspected HEV infection, hospitalised patients, blood donors and pregnant women.
The Elecsys Anti-HEV IgM assay showed an overall relative sensitivity and specificity of 98.7% and 99.4%, while Elecsys Anti-HEV IgG showed 99.1% sensitivity and 99.8% specificity.
In a separate development, Roche is reported as planning to invest $240m in Colombia over the next five years, as part of its plan to consolidate its presence in the country.
The Swiss healthcare company already invested $40m this year, with the inauguration of a new distribution centre on the outskirts of Bogota.