A Rapid Multiplexed Test for the Screening of Sepsis and Organ Dysfunction at the Point of Care

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Abstract Instadiagnostics (IDI) is developing a point-of-care (POC) diagnostic technology platform with the goal of providing early detection, screening, and treatment monitoring for patients at primary care centers, community clinics, urgent care centers, and emergency departments. The device consists of a portable reader (the InstaReader) and disposable cartridges (InstaCartridge). A range of disease specific cartridges will allow for multiple diseases be detected on a single device. The system's ability to provide clinical laboratory quality results in less than 15 minutes will give medical workers the capability to immediately diagnose patients, and allows patients to avoid additional trips to have blood drawn, lengthy wait times for results, or delays in diagnosis and follow up testing. IDI's diagnostic platform will improve patient care/satisfaction, medical outcomes, and workflow for healthcare providers, while reducing overall medical costs. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is closely associated with sepsis and it is rare that just a single organ is impacted, the higher number of organs impacted the higher is the risk for mortality. Globally sepsis is the most preventable cause of death and disability, with over 30 million cases diagnosed annually and 6 million deaths. In the U.S. the CDC estimates that there are approximately 1.7 million cases and 270,000 deaths annually. There is strong evidence that if diagnosed early, sepsis is largely preventable and organ dysfunction is reversible. Blood tests for infection, inflammation, and organ dysfunction can aid in the screening and early diagnosis of sepsis, especially in primary care facilities. However, most of these tests are performed in centralized laboratories and it can take hours or even days to get the results allowing for the progression to severe sepsis and organ failure. Therefore, an improved, multiplexed test, for screening high-risk individuals for sepsis and organ dysfunction performed immediately at the POC, is essential to improve prognosis for these individuals. Our overall Sepsis goal is to develop a multiplexed test for Procalcitonin (PCT), C-Reactive Protein (CRP), Lactate, Creatinine, Bilirubin, Blood Urea Nitrogen, Fibrinogen, and D-Dime. This Phase I will be focused on: Aim 1: Develop and characterize assays for PCT, CRP, Lactate and Creatinine Aim 2: Development of a multi-technology bread-board reader and multiplexed cartridge to simultaneously measure levels of PCT, CRP, Lactate, and Creatinine in the same sample Phase II will focus on expanding on the panel, and conducting a pilot clinical study to demonstrate the performance and utility of the test. It will then be followed with organ specific panels for further patient evaluation.