Genedrive PLC (LON:GDR) has announced the publication of a large independent multi-centre study evaluating the real-world performance of its HCV test in low and middle-income countries.
The study yielded sensitivity specifications of 96.2-100% and specificity specifications of 98.7-99.5%, depending on the site or viral load, meaning the HCV -ID Kit is effective as intended in the diagnosis of HCV infection in resource-limited settings.
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The authors highlighted a test fail rate of 1.6%, which the AIM-listed firm said shows that the system performs to this high standard even though the system operators in the study had no previous experience in molecular testing.
The study, published in the journal Diagnostics, 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, which 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 study was conducted by The Foundation for Innovative New Diagnostics (FIND), with grant funding provided by Unitaid.
The diagnostics firm said the findings also show the ability of the kit to identify all major HCV genotypes, the utility of requiring small volumes of plasma, so it can be done outside a hospital, and the lack of hazardous chemicals in the kit's construction, allowing for normal disposal processes versus competitor products that require heat incineration.
“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,” said chief executive David Budd in a release.
“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."