The study, published in the journal Diagnostics (Lamoury et al, 2021, 11, 746) was conducted in Georgia and Cameroon, and enrolled 426 participants, which had very different demographic backgrounds. The participants in the Georgia trial were almost all intravenous drug users. Intravenous drug users are a key patient population for HCV infection. The Genedrive sensitivity and specificity results were obtained by comparison to testing with the Abbott RealTime HCV Assay. The publication can be accessed on line at https://www.mdpi.com/2075-4418/11/5/746. The study was conducted by The Foundation for Innovative New Diagnostics (FIND), with grant funding provided by Unitaid.
The study’s findings also corroborate other key performance capabilities of the Genedrive® HCV ID Kit, including the ability of the kit to identify all major HCV genotypes, the utility of requiring small volumes of plasma, and the lack of hazardous chemicals in the Genedrive kits construction, allowing for normal disposal processes versus competitor products that require heat incineration.
David Budd, Chief Executive Officer of genedrive plc, said: “This study is the first large scale, independent multi centre evaluation from low and middle income markets using the Genedrive HCV test. While the performance results are as expected and excellent, it is equally gratifying to see these achieved with operators with no previous experience in molecular testing. Moving testing from highly complex and automated central hospital settings towards more simple decentralised settings is a balance of technological complexity, cost, performance, and usability, which is not always an easy balance to achieve. This study is an excellent demonstration of real world performance and the ability of Genedrive to contribute to fighting HCV in resource limited settings.”
The Genedrive® HCV ID Kit allows for decentralised molecular testing of Hepatitis C (HCV) by PCR, providing results within 90 minutes direct from a small plasma sample (30 µl). This allows for testing to be done outside of a large hospital facility and indeed while a patient may be waiting for a result. The assay is performed on the Genedrive® platform, the only truly portable molecular diagnostics system designed for diagnosing HCV at the point of need.
