A new approach to quantitative, point-of-care serology

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DESCRIPTION (provided by applicant): We have recently demonstrated a reagentless, electrochemical method, termed E-DNA sensors that can detect anti-HIV antibodies in undiluted human serum at levels thousands of times lower than those seen in HIV-positive patient samples. The approach is rapid (sub-10 min), single-step, and quantitative, thus improving significantly on the convenience and/or clinical value of existing molecular diagnostics. It is supported on micron-scale electrodes, and thus can be multiplexed to the level of measuring dozens of diagnostic antibodies in a single finger-prick droplet. Given these attributes, our technology appears well suited for applications that would derive value from the ability to measure quantitative antibody levels or the ability to simultaneously monitor multiple diagnostic antibodies at the point of care or in the field. The focus of the proposed research program is to test this hypothesis by performing the initial, pre-clinical validation of this novel molecular detection platform. Specifically, we will fabricate E-DNA arrays supporting the detection of one to two dozen antibodies diagnostic of a panel of sexually transmitted infections, and perform side-by-side tests of them against a set of gold standard approaches when both are challenged using a large set of authenticated human samples.