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.

项目摘要/摘要 美国正经历着史无前例的海洛因使用范围的流行 以及滥用处方阿片类药物（例如芬太尼）的滥用滥用的令人不安的普遍增加 衍生物，方法载体，羟考酮和氢可酮。 10种药物过量中有6多个是 现在与阿片类药物有关，每天约90人死亡，每年的经济影响超过$ 75B。 此外，还需要迅速扩展，以检测许多其他小分子，例如 治疗剂，在家庭中或潜在的WMD中 或字段设置。为了开发一种通用工具来解决这种检测，我们建议 我们完成的干涉读取器（CIR），并进一步开发了独特而高效的矩阵 不敏感的测定方法，以解决高灵敏度，阿片类药物快速测试的需求， 治疗和环境污染物。我们的努力将产生此类替补席 - 用于检测和/或 NG/ML-PG/ML敏感性的数量广泛，包括操作，小型 分子药物和有机磷农药。基于近表面测定的测定 （NSA）实施例，由三个步骤组成； 1）收集样品（如果需要的话稀释），2）填充前 涂层毛细管和3）用CIR读取“样品”。药物或代谢物检测结果 CIR的尿液预计芬太尼家族的尿液为<300 pg/ml敏感性，a> 10-1000倍 对最佳横向流程测试（LFT）1的改进和标准药物测试的当前临界值。 非侵入性的纳米素体积，高特异性尿液或缓冲液测定将有助于 快速基于现场的环境样品检测，扣押的非法麻醉品，伪造药物 和有机磷神经剂（OPNA）。类似的最小侵入性测定也是可行的 微量的手指粘血。新方法是通过三个结婚来实现的 获得专利技术，一种用于Atamer选择的多重核心方法，Atamer-probe 测定和CIR来量化目标。第一阶段和第二阶段的目标是旨在 实现提出技术的快速翻译/商业化。