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

描述(由申请人提供)：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，该方法实现了在未稀释、未处理的人血清中直接检测抗HIV抗体，浓度低于HIV阳性患者样本的浓度数量级。该方法快速(不到10分钟)、一步法和定量，从而改进了现有的护理点分子诊断的便利性和/或临床价值。进一步说，这种方法的潜在价值是在微米级的电极上得到支持，因此可以多路传输到在单个指刺样本中测量数十种诊断抗体的水平。考虑到这些属性，我们的技术似乎非常适合从定量测量中心实验室外的多种抗体水平中获得价值的应用程序。拟议的研究计划的重点是通过执行E-DNA抗体检测平台的初始临床前验证来测试这一假设。具体地说，我们将编造E 用于测量一到二十打抗体的DNA阵列，用于诊断三种性传播感染，并在使用真实人类样本挑战时，将这些方法与当前的黄金标准实验室方法进行并列比较。

DESCRIPTION (provided by applicant): We have recently demonstrated a reagentless, electrochemical method - termed E-DNA sensors - that achieves the detection of anti-HIV antibodies directly in undiluted, unprocessed human blood serum at concentrations orders of magnitude lower than those seen in HIV-positive patient samples. The approach is rapid (sub-10 min), single-step, and quantitative, thus improving on the convenience and/or clinical value of existing point-of-care molecular diagnostics. Further speaking to its potential value, the approach is supported on micron-scale electrodes and can thus be multiplexed to the level of measuring dozens of diagnostic antibodies in a single finger-prick sample. Given these attributes, our technology appears well suited for applications that would derive value from the ability to measure quantitatively the levels of multiple antibodies outside of central laboratories The focus of the proposed research program is to test this hypothesis by performing the initial, pre-clinical validation of the E-DNA antibody detection platform. Specifically, we will fabricate E DNA arrays for the measurement of one to two dozen antibodies diagnostic of a panel of three sexually transmitted infections, and perform side-by-side comparison of these against current gold standard laboratory approaches when both are challenged using authentic human samples.