Frankfurt am Main, January 22, 2021. – GFE today announced the CE-IVD approval of its PoET® HCV blood screening NAT test. The PCR kit is used on GFE’s new, fully integrated NAT testing solution, the PoET® System. With this NAT test GFE continues its tradition as a leading provider of high-quality blood screening solutions.
“Hepatitis C played a key role in establishing nucleic-acid based screening of donor blood in the late 1990ies. Since there is still no vaccination against HCV, sensitive screening remains an effective tool to control the spread of this virus.” said Dr. Reiner Babiel, CEO at GFE.
The CE approval marks another major milestone in the launch process for the entire PoET® product line. The PoET® system features a fully automated instrument and a series of blood screening tests. The market introduction of the PoET® product line is scheduled for spring 2021.
The PoET® HCV test features excellent sensitivity and a broad genotype coverage to effectively address the serology window period. The test is well suited for mini pool testing as well as confirmatory testing of individual donations. Effective mini pool testing enables laboratories to increase sample throughput at lower costs per sample while maintaining very high blood safety standards.
GFE is a wholly owned subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Blutspendedienst des Bayerischen Roten Kreuzes.