Grifols Diagnostic Solutions Inc, Barcelona, a leading company in the plasma-derived biological medicines and transfusion medicine sectors, has announced that its Procleix nucleic acid test (NAT) for the detection of hepatitis E virus (HEV) has received the CE mark, making it eligible for marketing throughout the European Union.

Clinical signs and symptoms of HEV infection include nausea and vomiting, malaise, loss of appetite, and jaundice. However, infections are frequently asymptomatic, and the disease course is usually self-limiting—except in cases involving pregnant women and the immunosuppressed, where fulminant hepatitis (acute liver failure) can develop.

Schroeder

Carsten Schroeder, Grifols

“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.

HEV 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.

Developed in collaboration with Hologic Inc, Bedford, Mass, the Procleix HEV test is the only validated nucleic acid test designed for fully automated and highly sensitive and specific detection of hepatitis E virus RNA in donors of blood, blood components, tissues, and organs. The qualitative assay is designed to detect all 4 genotypes of the hepatitis E virus.

The test 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 25 countries, with more than 160 instruments placed.

Grifols is a leader in plasma collection with a network of 150 plasma donor centers in the United States, and is a leading producer of plasma-derived biological medicines. The company also provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers, and is a recognized leader in transfusion medicine.

Procleix NAT solutions are developed under a long-standing partnership between Grifols and Hologic. Procleix products are used to test more units of donated blood worldwide than any other commercial NAT blood screening system.

For more information, visit Grifols.