Fully Automated Hepatitis E Virus Assay Now CE-marked

Clinical laboratories in Europe now have available a fully automated and highly sensitive NAT (nucleic acid technology) test with CE-marking for the detection of Hepatitis E virus (HEV) RNA in donors of blood, blood components, tissues, and organs.

The Procleix HEV assay is produced by Grifols Diagnostic Solutions Inc. (Barcelona, Spain) and was designed for use on the fully automated Procleix Panther analytical system, which is manufactured by Hologic Inc. (Bedford, MA, USA) and distributed by Grifols.


The assay employs nucleic acid amplification to detect all four genotypes of the hepatitis E virus 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 assay will be sold in the European Union for use on the Procleix Panther system, which performs nucleic acid extraction, amplification, and detection all in a single tube. The Procleix Panther system, which was launched in 2012, features built-in process controls for sample and results integrity, and boasts full sample traceability with positive sample ID tracking and RFID tagged fluids. The instrumentation provides precise pipetting with liquid level sensors and dispensers that facilitate consistency and accuracy of system results.

“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 Incorporated.

Related Links:
Grifols Diagnostic Solutions Inc.
Hologic, Inc.