SampleCAP: a power-free system for biomolecule concentration and preservation

A rapid and accurate diagnosis of infectious diseases is essential to reducing lost duty days for U.S. Service Members and accurately tracking outbreaks. Patient samples frequently require cold storage during transport to a centralized diagnostic laboratory. During transport, antigens and antibodies may be degraded by proteases present in specimen samples and lead to a false-negative diagnosis of the patient. Point-of-care diagnostics are an inexpensive, easy and rapid diagnostic tool but many of these assays lack the sensitivity of sophisticated laboratory equipment. This Phase II SBIR proposal builds upon our successful Phase I effort where we demonstrated our SampleCAP technology can decrease sample volume, concentrate biomolecules and increase downstream assay sensitivity using forward osmosis. In this effort we will improve the prototype device design, performance, and usability following feedback from the DoD and diagnostic laboratories to meet the sensitivity and specificity requirements set forth by the DoD. SampleCAP’s ability to increase sensitivity will be demonstrated with clinical human samples and stability testing of packaged devices will be performed according to military standards. At the end of Phase II we will have optimized the device design and be prepared for transition to production and field testing of the device.