WHO adds HEV tests including altona assay to their EDL List
The WHO has released its 2023 Essential Diagnostics List (EDL), an evidence-based register of in vitro diagnostics (IVD), to support countries in making diagnostic decisions and improve in vitro diagnostics testing services. Hepatitis E virus (HEV) has been recently added to this list, including a recommendation to use nucleic acid tests (NATs) like PCR assays to diagnose acute HEV infections especially in pregnant women and immunocompromised patients. One of the mentioned PCR tests in the EDL is the altona RealStar® HEV RT-PCR assay – a highly sensitive in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of hepatitis E virus (HEV) specific RNA.
Hepatitis E virus (HEV) is an RNA virus that can cause acute viral hepatitis. The virus is mainly transmitted through contaminated food (especially raw meat) or water. Most patients show no or only mild symptoms and fully recover from an infection, but in some cases hepatitis E can lead to acute liver failure. Especially pregnant women and immunocompromised patients are at higher risk of a severe disease progression. There is an estimated number of 20 million HEV infections worldwide per year, with about 3.3 million symptomatic cases and about 70.000 deaths. The symptoms in the early phase of an infection are often unspecific. Nucleic acid tests (NATs) are the gold standard for diagnosing acute HEV infections.
As HEV is a significant global health problem, the WHO has decided to recommend the use of NATs for the diagnosis of acute hepatitis E infection and included this in their Essential Diagnostics List (EDL) 2023. The report from the WHO refers to a publication from Vollmer et al. comparing 3 different PCR assays for the detection of HEV. The RealStar® HEV RT-PCR assay is classified as the most sensitive assay.
The RealStar® HEV RT-PCR Kit 2.0 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of hepatitis E virus (HEV) specific RNA. It can be used with various real-time PCR instruments and allows for sensitive detection and reliable quantification of HEV RNA. The assay is used by laboratories all around the world.
In addition, altona Diagnostics offers an automated solution for detection and quantification of hepatitis E virus (HEV). The AltoStar® HEV RT-PCR Kit 1.5 is designed for use with the AltoStar® Molecular Diagnostic Workflow, which automates PCR analyses from sample extraction to PCR results.