Biomolecule concentration and preservation by hydrogel driven forward osmosis for improved serological detection

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 sample matrices and lead to a false-negative diagnosis of the patient. Point of care diagnostics are emerging as an easy and rapid diagnostic tool but these assays lack the sensitivity of sophisticated laboratory equipment. In Phase I we will develop Sample CAP, a sample concentration and preservation device that requires no power input and will stabilize urine and serum samples at room temperature for at least 2 weeks. Samples will be rapidly concentrated by forward osmosis driven by hydrogel draw to increase assay sensitivity and preserved by addition of a specially formulated stabilizing additive compatible with serological assays. Once a sample is loaded into Sample CAP no user intervention is required until serological analysis of biomolecules. In Phase II we will use the feedback from Department of Defense testing to improve Sample CAP performance to meet sensitivity and specificity requirements set forth by the DoD. We will also conduct stability testing