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

定量、护理点血清学的新方法

基本信息

批准号：
9306748
负责人：
Kevin W Plaxco
金额：
$ 35.8万
依托单位：
UNIVERSITY OF CALIFORNIA SANTA BARBARA
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9306748
关键词：
Affinity Antibodies Antibody Repertoire Antigens Appearance Bedside Testings Binding Biological Assay Biological Markers Blood Blood specimen Clinic Clinical Clinical Sensitivity Communicable Diseases Complex DNA Detection Development Devices Diagnosis Diagnostic Disease Effectiveness Electrodes Electronics Elements Epitopes Fingers Fluorescence Polarization Generations Goals Gold HIV HIV Antibodies HIV Seropositivity HIV-1 Hand Health Personnel Herpes Simplex Infections Home environment Human Immune response Infection Laboratories Lateral Length Life Measurable Measurement Measures Medical Methods Military Personnel Modification Molecular Weight Monitor Nucleic Acid Probes Outcome Oxidation-Reduction Patients Peptides Performance Physicians Predictive Value Prevalence Proteins Public Health Reagent Reporter Reporting Reproducibility Research Sampling Sensitivity and Specificity Serodiagnoses Serologic tests Serological Serum Sexually Transmitted Diseases Side Signal Transduction Speed Syphilis Technology Temperature Testing Validation Venous Whole Blood Work World Health Organization analog base clinically actionable clinically relevant cost cost effective design diagnostic biomarker diagnostic panel glucose monitor improved molecular diagnostics multiplex detection novel strategies point of care portability pre-clinical programs protein biomarkers public health relevance research clinical testing response sensor standard of care success

项目摘要

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.

描述（由申请人提供）：我们最近证明了一种无试剂电化学方法-称为E-DNA传感器-可直接检测未稀释、未处理的人血清中的抗HIV抗体，其浓度低于HIV阳性患者样本中的浓度。该方法是快速的（低于10分钟），单步和定量的，从而提高了现有的即时分子诊断的便利性和/或临床价值。进一步谈到其潜在价值，该方法支持微米级电极，因此可以多路复用到测量单个手指针刺样品中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于从中心实验室外定量测量多种抗体水平的能力中获得价值的应用。拟议研究计划的重点是通过对E-DNA抗体检测平台进行初始临床前验证来验证这一假设。具体来说，我们将创建E DNA阵列用于测量一到二十打抗体，诊断一组三种性传播感染，并将这些抗体与当前的金标准实验室方法进行并排比较，当两者都使用真实的人类样本进行挑战时。