Our vision is to provide healthcare professionals with a simple to use point of care device to regularly screen for Covid-19 coronavirus. In the current pandemic there is an urgent need for a simple, accurate and rapid diagnostic test to screen for Covid-19. Tests currently are mostly molecular or serological. These tests will not provide an immediate answer since swab samples are sent off to labs for further testing. A further problem is that current tests suffer from a high degree of false negatives indicating they are not sensitive enough. The plan is to develop a reader with proprietary electronics that can detect signals from a slide strip with a single drop of blood within 2 minutes of sampling. The objective to complete a small in-house pilot study on stored samples from patients admitted to ITU so that the parameters can be determined for sensitivity and specificity which will enable us to move towards a larger clinical study post this short project. We have already advanced a similar project for the rapid detection of sepsis and will follow a similar route to market path for this device. Over the 9-month project the team will generate several thousand slide strips to test that will have been laser cut and reagent coated by our sub-contracting partner. The second 3-9 months, they will be tested using stored blood samples from coronavirus patients who have been admitted to intensive care at the hospital we already work with for sampling patients with suspected sepsis. The data will be used to prepare a data pack to engage a license partner or raise further investment to conduct a clinical trial. The team has engaged with a UK medical technology company that has the expertise to take medical devices from concept to market in less than 4 years. Based on significant in-house experience of diagnostics tests and devices together with expertise in electronic signatures specific to proteins and other molecules and biomarkers, our team has developed a unique and novel platform for detecting proteins interacting with other molecules. This has already been validated for our proprietary sepsis specific complex biomarker and is the next focus of innovation. The interaction of the surface of Covid-19 protein with haemoglobin in blood cells has been elucidated by the team and is detectable by this method. A patent has recently been filed to protect this innovation.

Based on a clinically validated biological assay the project will deliver a prototype point of care device to be used directly at the bed-side of a patient that is capable of diagnosis of bacterial sepsis within minutes of mixing serum/plasma with a reagent solution. The assay detects abnormal blood chemistry before standard physiological sepsis is diagnosed and this has been shown in children and adults in settings that include the emergency room, postsurgery, oncology and intensive care units. The technology has already demonstrated some early technical feasibility with small volume reagents, but still requires coupling with a bespoke hand held reader to deliver a test result from a 'pin-prick' of blood allowing bed-side format from sample to result. The result can be both qualitative for diagnosis (Yes/No) and quantitative for repeated use. It will be designed to frequently monitor the progression of the symptoms with a view to reducing overuse of antibiotics. The ultimate aim is to develop a product that will be the most effective point-of-care (POC) device for the diagnosis of bacterial sepsis on the market and thus address the global health issue of rising sepsis mortality. The planned work scheduled over the next 12 months will consist of a series of different models that will test functionality of interacting components in order to optimise conditions for a small demonstrator device, generate new IP and interact with health care professional end users such that their requirements for appropriate intervention are met.