STTR Phase I: Development of a novel device that simplifies and expedites blood-based diagnosis of infectious diseases

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) project is the development of a simpler and more rapid assay that can be used for diagnosis of tuberculosis (TB) and other infectious diseases. TB testing is an important public health task in both developed countries and in the developing world, as approximately 2.2 billion people have been exposed to TB and may be carriers of this disease. Currently, 22 million TB tests are carried out annually in the United States alone, with per test reimbursement rates ranging from $12 to $70, making this a significant market opportunity. However, existing TB diagnostics based on a skin reaction are imprecise and have high rates of false positives, particularly in immigrants or foreign visitors and students. The proposed biosensor-based diagnostic test will use a small blood sample, and promises to greatly reduce false-positives and, unlike a skin test that takes 48 hours to complete, will provide a result within several hours. In addition to the proposed TB diagnostic test, the technology developed during this project will be a platform technology that may be applied to the development of diagnostic tests for a wide range of infectious diseases. This SBIR Phase I project proposes to develop a biosensor platform for detection of inflammatory cytokines commonly associated with Tuberculosis (TB) infection where specificity for the analyte is conferred by selection of atpamers. This sensing technology will be broadly applicable for making simple and sensitive affinity measurements in complex physiological liquids. The platform will be built to mimic a micro-titer plate and will be integrated with electrodes for detection of interferon gamma (IFN-gamma) and tissue necrosis factor alpha (TNF-alpha) from whole human blood. The use of atpamers will allow the detection of cytokines in blood without additional washing or labeling steps. Availability of such a platform will address the need for developing simpler and faster alternatives to enzyme-linked immunosorbent assays commonly used for detection of infectious diseases such as TB. Specific objectives of the project will include designing more sensitive aptamer-based biosensors for detection of IFN-gamma and TNF-alpha, and developing hydrogel coatings to minimize electrode fouling.