Bench-top Reader and Aptamer-based Assay for Rapid, High-sensitivity Drug/Opiate Detection

用于快速、高灵敏度药物/阿片类药物检测的台式读数仪和基于适体的检测

• 批准号: 10760088
• 负责人: George W Jackson
• 金额: $ 26.61万
• 依托单位: BASE PAIR BIOTECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760088
• 关键词: Acids; Address; Biological Assay; Blood; Blood capillaries; Buffers; Calibration; Cessation of life; Chemicals; Chemistry; Compensation; Computer software; Detection; Development; Ensure; Environment; Environmental Pollutants; Epidemic; Family; Fentanyl; Fingers; Generations; Gold; Home; Hydrocodone; Immobilization; Label; Laboratory Research; Lasers; Legal patent; Letters; Manufacturer; Marketing; Marriage; Methadone; Methodology; Methods; Morphine; Narcotics; Norepinephrine; Norfentanyl; Opioid; Optics; Overdose; Oxycodone; Patients; Peer Review; Pesticides; Pharmaceutical Preparations; Phase; Physicians' Offices; Preparation; Production; Publications; Pump; Reader; Reproducibility; Rural Hospitals; Sampling; Sarin; Serum; Specificity; Surface; Surface Tension; System; Technology; Technology Transfer; Tenofovir; Testing; Therapeutic; Therapeutic Agents; Toxic Environmental Substances; Training; Translations; Ultraviolet Rays; United States; Update; Urine; VX nerve gas; Vendor; Walking; Work; aptamer; commercialization; design; detection platform; drug sensitivity; drug standard; drug testing; economic impact; experience; glyphosate; heroin use; improved; instrument; large scale production; lateral flow assay; liquid chromatography mass spectrometry; minimally invasive; nanolitre; nerve agent; novel; prescription opioid abuse; prototype; rapid test; rapid testing; small molecule; tool; user-friendly

Project Summary/Abstract The United States is experiencing an epidemic of unprecedented scope with heroin use resurging and a troubling pervasive increase in abuse of prescription opioids such as fentanyl, fentanyl derivatives, methadone, oxycodone and hydrocodone. More than 6 out of 10 drug overdoses are now opioid-related, resulting in ~90 deaths/day and a more than $75B/year economic impact. Additionally, there is a rapidly expanding need to detect numerous other small molecules such as therapeutic agents, in the home or potential WMDs like sarin and toxic pesticides in the remote or field setting. To develop a general purpose tool to address such detection, we propose to refine our compensated interferometric reader (CIR) and further develop a unique and efficient, matrix insensitive, assay methodology to address the need for high sensitivity, rapid testing of opioids, therapeutics and environmental contaminants. Our efforts will produce a first of its kind bench- top (and field-compatible) CIR and user-friendly (turn-key) assay system for the detection and/or quantification at ng/mL-pg/mL sensitivity of a wide range of targets including opiates, small molecule drugs, and organophosphorus pesticides. The assay based on a near-surface assay (NSA) embodiment, consists of three-steps; 1) collect sample (dilute if needed), 2) fill the pre- coated capillary and 3) read the ‘sample’ with CIR. Results for drug or metabolite detection in urine by CIR is predicted to be <300 pg/mL sensitivity for the fentanyl family, a >10-1000-fold improvement over the best lateral flow tests (LFT)1 and the current cutoff for standard drug tests. The non-invasive, nanoliter volume, high specificity urine or buffer-diluent assays will facilitate rapid field-based detection of environmental samples, seized illicit narcotics, counterfeit drugs and organophosphorus nerve agents (OPNA). Similar minimally invasive assays are feasible with minute amounts of finger-stick blood. The novel methodology is enabled by the marriage of three patented technologies, a multiplex-SELEX approach for aptamer selection, an aptamer-probe assay, and CIR to quantify the target. Phase I and Phase II Aims proposed here are designed to enable rapid translation/commercialization of the proposed technology.

项目概要/摘要 美国正在经历一场规模空前的流行病，海洛因吸食死灰复燃 滥用处方阿片类药物（如芬太尼、芬太尼）的现象普遍增加，令人不安 衍生物、美沙酮、羟考酮和氢可酮 超过十分之六的药物过量。 现在与阿片类药物相关，每天导致约 90 人死亡，每年造成超过 75B 美元的经济影响。 此外，检测许多其他小分子的需求正在迅速扩大，例如 家中的治疗剂或远程的沙林毒气和有毒杀虫剂等潜在大规模杀伤性武器 为了开发一个通用工具来解决此类检测，我们建议进行改进。 我们的补偿干涉式读取器 (CIR) 并进一步开发了独特且高效的矩阵 不敏感的检测方法，以满足高灵敏度、快速检测阿片类药物的需求， 我们的努力将产生第一个此类实验台。 顶级（和现场兼容）CIR 和用户友好（交钥匙）检测系统，用于检测和/或 以 ng/mL-pg/mL 灵敏度对多种目标（包括阿片类药物、小分子药物）进行定量 分子药物和有机磷农药的测定基于近表面测定。 (NSA) 实施例，由三个步骤组成；1) 收集样品（如果需要，请稀释），2) 填充预样品 涂层毛细管和 3) 使用 CIR 读取“样品”结果以进行药物或代谢物检测。 预测 CIR 尿液对芬太尼家族的敏感性 <300 pg/mL，>10-1000 倍 比最佳侧向层析测试 (LFT)1 和标准药物测试的当前截止值有所改进。 非侵入性、纳升体积、高特异性尿液或缓冲稀释液测定将有助于 快速现场检测环境样本、查获的非法麻醉品、假药 和有机磷神经毒剂（OPNA）也可进行类似的微创检测。 这种新颖的方法是通过三人的结合而实现的。 专利技术、用于适体选择的多重SELEX方法、适体探针 此处提出的 I 期和 II 期目标旨在量化目标。 实现所提议技术的快速转化/商业化。