CONTEXT: Commercial announcement of a study conducted in the Real-world on a HCV test. Small numbers of patients involved and no details of the research, so by way of caution, this may or may not fall under the RWR banner. Still, good to see that companies feel the need to explore their products outside of the mainstream to demonstrate value.
IMPACT: Medium
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 5
1. “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.”
2. “( ) 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.”
3. “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.”
4. “The Genedrive sensitivity and specificity results were obtained by comparison to testing with the Abbott RealTime HCV Assay.”
5. “This study is an excellent demonstration of real-world performance and the ability of Genedrive to contribute to fighting HCV in resource-limited settings.””