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

描述（由申请人提供）：我们最近证明了一种无试剂的电化学方法，称为E-DNA传感器，可以检测未稀释的人血清中的抗HIV抗体，其水平比HIV阳性患者样本低数千倍。该方法是快速的（低于10分钟），单步，和定量，从而显着提高现有的分子诊断的便利性和/或临床价值。它支持在微米级电极上，因此可以多路复用到测量单个手指针刺液滴中的数十种诊断抗体的水平。鉴于这些属性，我们的技术似乎非常适合于从测量定量抗体水平的能力或在护理点或现场同时监测多种诊断抗体的能力中获得价值的应用。拟议研究计划的重点是通过对这种新型分子检测平台进行初步临床前验证来验证这一假设。具体来说，我们将制造E-DNA阵列，支持检测一到二十打诊断性传播感染的抗体，并在使用大量经认证的人类样本进行挑战时，对一组金标准方法进行并行测试。

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.