Sepsis is a pathological condition that can lead to septic shock and death if not controlled. It is very difficult to rapidly determine if a patient is suffering from a bacterial infection (sepsis) so many patients are inappropriately treated and/or hospitalized. It is critical to make this determination because bacterial infections can be controlled by immediate treatment with antibiotics. The current """"""""gold standard"""""""" test for sepsis is blood culture, which takes 48 to 72 hours to indicate a diagnosis. AndCare's proposed solution is to incorporate nucleic acids into its well-developed biosensor technology to produce a diagnostic product that will detect and quantify the bacterial load in patient blood in hours rather than days. Amperometric instrumentation and sensors coated with oligonucleotides couple to electrochemical reporter groups and measure current signal proportional to bacteria concentration. Bacterial genes will be amplified by the Polymerase Chain Reaction (PCR) using primers that are conserved among all bacteria. The expected result is an electrochemical sensor system that detects and quantifies levels of bacteria-specific DNA or RNA in human blood. Dr. Henkens and his staff have pioneered the integration of colloidal gold electrodes with electrochemical monitors. This technology is the platform that will be used in this project.
The health care market has a strong need for a diagnostic device that can rapidly quantify bacteria load (sepsis) in patient blood. Such a device would assist health care providers in making clinical decisions about patient hospitalization and administration of antibiotics, and reduce the unnecessary and potentially harmful application of these measures. The same device would service patients in various settings such as bedside, emergency room, clinic, home, and other remote sites.