Frankfurt am Main, March 12, 2021. – GFE announced the CE-IVD approval of its PoET® HIV 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.
“Despite a variety of powerful therapies, there is still no cure for or vaccination to prevent HIV infections. Therefore, transmission risk reduction particularly regarding transfused blood or blood components remains a key priority.” said Dr. Reiner Babiel, CEO at GFE. “Our Assay Development has redesigned the HIV assay, now allowing to detect all HIV clades including HIV-2 in one assay, either in screening or confirmatory format. In total five amplicons seamlessly work together to achieve superior performance and safety.”
The CE approval marks a major milestone in the launch process for the PoET® product line. The PoET® system features a fully automated instrument and on top of HCV, HBV and HIV an extensive menu for blood screening tests, including HAV, B19V, HEV and WNV. The market introduction of the PoET® product line is scheduled for spring 2021.
The PoET® HIV test features excellent sensitivity and a broad subtype coverage to effectively address the serology window period. The test is designed 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 organizations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Blutspendedienst des Bayerischen Roten Kreuzes.