- PoET® CMV is the first IVD assay on the market to screen donated blood for CMV by nucleic acid amplification technology (NAT) under the IVDR.
- Screening blood donors with the PoET® CMV test enables pathogen detection and reduces the risk of transfusion of infected blood or blood components.
- The CE mark for the PoET® CMV strengthens GFE’s PoET® portfolio for blood donor screening and underlines the company’s commitment to safe blood transfusions.
Frankfurt, 20.06.2024 – GFE today announced the CE IVD certification of its new PoET® CMV assay under the European Union’s In-Vitro Diagnostic Medical Devices Regulation (IVDR). PoET® CMV is the first IVD assay on the market to screen donated blood for CMV by nucleic acid amplification technology (NAT) under the IVDR.
CMV is a common and widespread virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. However, CMV infections can cause serious health problems for people with weakened immune systems, as well as babies infected with the virus before they are born (congenital CMV).
CMV NAT testing can prevent CMV transmissions by blood transfusion, but NAT screening for CMV is currently not mandatory. The PEI Hemovigilance reports show that CMV transmissions can occur, but screening all donors can be a costly endeavour.
Highly sensitive NAT assays can be used to test sample pools and thus reduce work load and costs of screening.
The newly developed PoET® CMV assay delivers excellent performance and very high sensitivity. PoET® CMV enables customers to efficiently perform NAT screening for CMV with pooled samples and thereby to reduce the risk of transfusion of infected blood or blood components at manageable costs and workloads.
The PoET® CMV Assay is part of the PoET® System, a fully integrated, automated NAT solution for routine molecular testing of blood donations. PoET® Instrument reaches a new level of integration and covers the entire workflow from sample pooling, to sample preparation and PCR testing on a single platform.
With the reduction of workload and costs by testing pooled samples, routinely screening a higher percentage of donors to improve blood safety is rendered more feasible.
PoET® CMV with its associated PoET® CMV positive control is a valuable addition to GFE’s PoET® portfolio of CE-marked in vitro diagnostic NAT assays which also includes tests for HCV, HBV, HIV, HAV, B19V, HEV and WNV.
About GFE:
GFE – Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen – develops, manufactures and distributes fully integrated diagnostic systems for molecular (NAT) screening of blood donations.
GFE emerged from donor screening centres of the German Red Cross. The German Red Cross Blood Donation Service NSTOB & Mecklenburg-Vorpommern and the Blood Donation Service of the Bavarian Red Cross are the shareholders of GFE. Based on the extensive experience gained from the many millions of blood donations tested, GFE has developed and launched the PoET® line and became one of the few companies providing NAT assays for blood donation screening.