Test To Screen Donors of Blood, Tissues, and Organs for Hepatitis E Virus Receives CE Mark
The test, which uses nucleic acid technology (NAT) to detect Hepatitis E virus, will run on the fully automated Procleix Panther system in the EU
Grifols, one of the world’s leading companies in the plasma-derived biological medicines and transfusion medicine sectors, has announced CE mark for the Procleix HEV assay. The test, developed in collaboration with Hologic, Inc. (HOLX), is the only validated NAT test designed for fully automated and highly sensitive and specific detection of Hepatitis E virus (HEV) RNA in donors of blood, blood components, tissues, and organs.
“As the leading provider of NAT solutions to support safe transfusions and efficient, high-quality testing, we are proud to have accelerated development of this test – already scheduled for use in Japan – to meet the needs of the blood community”, said Carsten Schroeder, President of Grifols Diagnostic Solutions Inc.
The Procleix HEV assay is designed to detect all 4 genotypes of the hepatitis E virus. It will be sold in the EU for use on the Procleix Panther system, which offers full automation, simple operation, and a broad test menu in a small footprint. Since its launch in 2012, the Procleix Panther system has become the solution of choice for blood banks in more than 25countries, with more than 160instruments placed to date.
Procleix NAT solutions, which tests more units of donated blood worldwide than any other commercial NAT blood screening system, are developed under a long-standing partnership between Grifols and Hologic.
The Procleix HEV Assay and the Hepatitis E Virus
The Procleix HEV assay for blood donations is a qualitative in vitro nucleic acid amplification test for the detection of Hepatitis E virus (HEV) RNA in plasma and serum specimens from human donors, tested individually or in pools. It is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (non-heart-beating) donors.
The Hepatitis E virus is classified into 4 major genotypes.Genotypes 1 and 2, considered human viruses, often cause disease in the resource-limited world and are transmitted primarily through contaminated water and fecal-oral routes. Genotypes 3 and 4, commonly found in domestic and wild pigs, are found throughout the world and are the cause of human infections associated with consumption of undercooked meats and shellfish.
Clinical signs and symptoms of HEV infection include nausea/vomiting, malaise, loss of appetite, and jaundice. Infections are frequently asymptomatic, however, and the disease course is usually self-limited – with the exception of pregnant women and the immunosuppressed where fulminant hepatitis (acute liver failure) can develop.