Molecular diagnostics company Lucence and the Agency for Science, Technology and Research (A*STAR) today announced study results indicating that the reagent used in Lucence’s SAFER Sample saliva collection kit inactivates SARS-CoV-2 within 45 seconds of sample collection. This proprietary reagent also stabilizes viral RNA at room temperature for up to one week. Together, these properties enable accessible, non-invasive, and safe sample collection via saliva, which is critical to scaling cost-effective testing worldwide. The reagent used in Lucence’s SAFER Sample kit was invented at A*STAR’s Institute of Bioengineering and Nanotechnology.
The SAFER Sample Saliva Collection Kit is registered as a Class A medical device with the Health Sciences Authority of Singapore and is an easy-to-use saliva collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week. While conventional viral transport media requires cold-chain transport to prevent sample degradation, which can drive up associated costs and limit testing geography, SAFER Sample’s proprietary media means samples can be transported to a lab without the need for chilling.
In this new study, Lucence and A*STAR demonstrated that the proprietary reagent provided with the SAFER Sample kit also achieved complete inactivation of SARS-CoV-2 virus within 45 seconds of exposure. Conventional viral transport media used for collecting nasal and nasopharyngeal swab specimens do not inactivate viral samples, creating risk of exposure to active virus during transportation from collection sites to the laboratory and higher costs associated with biohazard handling procedures. SAFER Sample kit’s viral inactivation capabilities could mean enhanced safety and reduced risk of exposure for any individual involved in the collection, transport, and testing processes. Lucence worked with the Diagnostics Development (DxD) Hub of A*STAR to evaluate the virucidal properties of the SAFER Sample reagent. Duke-NUS Medical School was also engaged to perform the virucidal work with SARS-CoV-2 virus.
Mass testing and screening of large populations is key to reduce the risk of COVID-19 transmission, morbidity and mortality. By eliminating obstacles to sample integrity and, now, biosafety through viral inactivation, the SAFER Sample kit could expand testing geography, decrease associated costs, and increase efficiency of testing at scale compared to approaches utilizing conventional viral transport media.
Studies with clinical partners are ongoing to further evaluate the performance of the SAFER Sample kit. With the support of DxD Hub in verification and validation, quality management system (QMS), and regulatory registration, Lucence has received ISO13485:2016 certification for its QMS which controls the processes for the manufacture of the SAFER Sample Saliva Specimen Collection Kit.