SBIR Phase II: Microfilm to enable enhanced mixing in low-resource diagnostics

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in its ability to improve healthcare in fundamental ways, such as (1) low volume draws that will enable diagnostics in low-resource settings like drug stores, at home, or in developing countries, (2) higher quality small-volume samples to make Point-of-Care (POC) diagnostics more competitive with lab tests, enabling faster results in critical care/outpatient environments, and (3) low draw volumes, coupled with small volume diagnostic tests, that will enable improved care for patients at risk for hospital-acquired anemia, including neonates and patients with bone marrow damage caused by cancers or suppressed bone marrow due to cancer drugs. Our technology will enable medical testing from a small amount of blood, which could significantly impact global neonatal and pediatric healthcare, particularly in developing countries, and expand the market for blood containers. This project aims to design a microliter-scale blood container that offers the same analytic stability and consistency as blood samples obtained by larger volume tubes. Critical to specimen stability is the ability to rapidly and uniformly distribute an anticoagulant in a blood specimen. In larger containers, mixing is achieved by shaking a collection tube, creating turbulent flow wherein eddies and vortices mix the blood with the stabilizing reagent. In low volume containers, fluid flow is laminar and shaking does not produce mixing. Typical low volume containers rely on diffusion driven mixing. This process is slow, and frequently results in the formation of micro-clots prior to complete specimen stabilization. We will use our proprietary actuated, surface-attached posts (ASAP) to rapidly and thoroughly distribute anticoagulant in blood, increasing the accuracy and the reproducibility of results obtained from small volume draws. This project will begin with an assessment of the biocompatibility of materials and specimen processing procedures. We will test a number of ASAP configurations in order to minimize the time required for specimen stabilization. The project will culminate with the production of a fully functional prototype that will be validated via comparison against blood stabilized in a larger volume specimen tube.