Accompanied by severe life-threatening systemic inflammation, sepsis causes organ dysfunction and is responsible for more than 250,000 annual deaths in the US. Precisely detecting the early onset and time-varying inflammatory status of sepsis in real time at the point of care (POC) is essential for a future paradigm shift toward precision therapy of the severe inflammatory disorder. There is a similar need in the resuscitation of victims of trauma, cardiac arrest, acute respiratory distress syndrome (ARDS) and other states of critical illness and injury.

The current critical care practice lacks a means to monitor patients’ inflammatory blood biomarker profiles dynamically varying over the course of their illnesses. As a result, caregivers are forced to take therapeutic strategies with limited guidance or no feedback to the treatment. 

MCIRCC researchers aim to develop an innovative handheld POC biomarker immunosensor module named the Smart Pipette.The Smart Pipette is a battery-operated, highly portable, pipette-shaped biomarker analysis microsystem that is wirelessly connected to a smartphone for data transmission and analysis. The biosensor data is analyzed and correlated with sepsis severity, treatments, and outcomes using a machine learning technique in order to develop algorithms to timely intervene and predict the development of sepsis. 

SIGNIFICANT NEED

The gold standard for sepsis diagnosis has traditionally been a combination of physiologic and blood parameters coupled with microbial cultures to identify the source of illness. However, a positive culture may take over 48 hours to incubate, and false negative results are common due to the low density of blood bacteria at the early stage of infection. A promising alternative method is capturing and analysis of blood circulating biomarkers that can diagnose and quantitate the degree of inflammation associated with a critical illness or injury as well as to rapidly inform clinicians of the impact their treatments are having. In order for this to become a reality, there is the need for a new blood biomarker detection technology, like the Smart Pipette, to enable both timely and accurate biomarker-guided diagnosis and treatment.

COMPETITIVE ADVANTAGE

The Smart Pipette provides a multi-analyte, multi-time-point systemic inflammatory biomarker analysis at the point of care. The multi-time-point detection with high time resolution is possible owing to the device’s short (< 30 min) sampling-to-answer time and sample sparing capability. The multi-biomarker detection approach coupled with a machine learning algorithm advances the way for precision therapeutics for individuals with sepsis.