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

描述(申请人提供)：我们最近展示了一种称为E-DNA传感器的无试剂电化学方法，它可以检测到未稀释的人血清中的抗HIV抗体水平，比在HIV阳性患者样本中看到的水平低数千倍。该方法快速(不到10分钟)、一步法和定量，因此大大提高了现有分子诊断的便利性和/或临床价值。它被支撑在微米级的电极上，因此可以多路传输到在单个指刺液滴中测量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应用，这些应用将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个诊断抗体的能力中获得价值。拟议的研究计划的重点是通过对这个新的分子检测平台进行初步的临床前验证来检验这一假设。具体地说，我们将制造支持检测一到二十多种抗体的E-DNA阵列，以诊断一组性传播感染，并在使用大量经过验证的人类样本对这两种方法进行挑战时，针对一组黄金标准方法对它们进行并排测试。

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.