Source: Clinical Laboratory News
The CE mark has been granted to Genedrive for the Genedrive HCV ID kit, a qualitative assay for hepatitis C virus (HCV) that is performed on the Genedrive instrument, a point-of-care molecular diagnostics system. In contrast with traditional diagnostic testing for HCV, which is complex and often limited to specialized hospital laboratories, the Genedrive HCV ID kit is designed for low throughput and/or decentralized labs. This assay is performed directly from a 25 µL plasma sample, does not require a separate viral nucleic acid extraction process, and provides results within 90 minutes. The test is also designed to be environmentally robust and can be performed in humid conditions with support from a main or uninterrupted power supply, with no instrument calibration or maintenance required. Performance evaluation studies to support CE marking of the Genedrive HCV ID kit were completed by Institut Pasteur in Paris, France, and Queen’s Medical Centre in Nottingham, England.