SBIR Phase II: Innovative Platform for Low Volume Blood Coagulation Analysis

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the problem of blood clotting and associated bleeding risks in neonatal and pediatric patients as well as vulnerable adult patients. Existing systems put these patients at further risk because they cannot operate with low volumes of blood, and because they are less reliable owing to the requirement for test sample contact. Using only a single drop of blood, the proposed non-contact technology platform enables safe and reliable assessment of blood clotting for all patients and provides an opportunity for development of newborn screening tests for coagulation abnormalities. This technology can reduce side effects for neonatal and pediatric patients by using 1/100th the sample volume required by technologies developed for adult healthcare and improve diagnostic response time for critical care providers by more than 3x. This technology could decrease the cost of blood coagulation analysis by over 30%, thus allowing for patients in the United States to save $1.1 billion annually.This Small Business Innovation Research (SBIR) Phase II project develops an innovative technology for non-contact blood coagulation analysis that integrates photo-optical and viscoelastic measurements in a single drop of blood. The basis of the technology is to levitate a small sample in a host fluid (air) by the acoustic radiation force and measure its physical properties under deformation during levitation. Due to its non-contact feature and low sample volume requirement, this technology can rapidly (10 minutes) and reliably assess bleeding/thrombotic risks and is sensitive to temporal changes in shear viscosity and elasticity during blood clotting and fibrinolysis. The goal of this project is to develop and test a system for fast, reliable, and easy-to-use drop-of-blood coagulation analysis under sterile conditions. This goal will be achieved by meeting four objectives: 1) develop the module for automatic sample deployment from standard blood collection tubes; 2) implement environmental control and sample containment (“acoustic cartridge”); 3) assemble prototype devices and develop the control software with improved workflow and a user-friendly interface; and 4) assess prototype reliability, standardize it for coagulation measurements, and conduct initial clinical testing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.