Development of multimode vacuum ionization for use in medical diagnostics

开发用于医疗诊断的多模式真空电离

• 批准号: 10697560
• 负责人: Charles N McEwen
• 金额: $ 15.91万
• 依托单位: MSTM, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-10 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697560
• 关键词: 2019-nCoV; Achievement; American; Analytical Chemistry; Artificial Intelligence; Atmospheric Pressure; Automation; Automobile Driving; Award; Biochemistry; Biological; Body Fluids; COVID-19; Cessation of life; Chemicals; Chemistry; Collaborations; Communicable Diseases; Computer Assisted; Data; Detection; Development; Disease; Doctor of Philosophy; Equipment; Event; Exposure to; Faculty; Fingerprint; Future; Gases; Goals; Grant; Hand; Health; Health Technology; Healthcare; Healthcare Market; Individual; Industrialization; Industry; Infection; Infectious Agent; Intervention; Ions; Legal patent; Letters; Licensing; Maintenance; Manuals; Manufacturer; Mass Spectrum Analysis; Measurement; Mechanics; Medal; Medical emergency; Methods; Molecular; Overdose; Pain; Performance; Pharmaceutical Preparations; Phase; Play; Poison; Renaissance; Reproducibility; Research; Research Personnel; Safety; Saints; Sales; Sampling; Semiconductors; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Societies; Solid; Source; Spanish flu; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Speed; Technology; Testing; Tissue Sample; United States National Institutes of Health; Universities; Urine; Vacuum; Virus; Volatilization; Water; Work; biothreat; clinical diagnostics; commercialization; cost; cost effective; current pandemic; design; design and construction; experience; fungus; high throughput technology; improved; innovation; instrument; instrumentation; interest; invention; ion source; ionization; ionization technique; machine learning algorithm; manufacture; mass spectrometer; member; new product development; new technology; next generation; operation; pathogen; portability; professor; programs; prototype; rapid testing; success; user-friendly

There is a critical need for rapid and cost-effective means for the detection of e.g. infectious diseases at an early stage, drug overdoses, and other health related testing necessities. Thus, significant commercial opportunities exist because of the lack of these capabilities as painfully “demonstrated” in the current pandemic. Mass spectrometry (MS), because of its ability to detect hundreds, even thousands, of biological compounds in a single acquisition provides the capability to distinguish chemical differences associated with, e.g., different pathogens and disease states, as well as target specific compounds in bodily fluids. Current MS approaches use ionization methods requiring user expertise and frequently specialized instrumentation, which significantly increases cost. Over the past 30 years, mass spectrometers have undergone a renaissance in their cost-to-capability ratio. For more widespread applications of MS in advancing healthcare, there is a need for new advanced ion source technology that provides for minimal user intervention and long-term use without maintenance. These attributes are necessary if testing of thousands of individuals daily per instrument to e.g., identify, track, and contain the spread of infectious diseases is to be implemented using MS in the future. The goal of this NIH SBIR Phase I project is to demonstrate that an entirely new ion source concept constitutes a disruptive technology and effective method that can be used for the next-generation disease test measurements. The basic invention of this proposal is covered by a MSTM patent application (#20210343518, March 31, 2021), and earlier IP exclusively licensed to MSTM which can be applied to widely available atmospheric pressure ionization mass spectrometers, including portable and ultra-high performance. Critical advantages include exceptional ease of use, robustness to instrument contamination and carryover, high-throughput, low cost, and the capability to retrofit with most commercial mass spectrometers to provide rapid, sensitive, and accurate data on demand. The objective of this Phase I project is to demonstrate the feasibility of this technology by constructing a manual dual vacuum ionization source that can be automated in Phase II for nearly hands-free operation and disease identification through machine learning algorithms. The specific aims towards establishing a potentially disruptive healthcare technology: Aim 1: Construct a manual vMAI/MALDI source capable of future automation (minimal viable product). Aim 2: Demonstrate high sensitivity, reproducibility, robustness, speed of analysis, as well as ease of use, quantification, accurate mass, MS/MS, and fingerprint analyses of pathogens. MSTM has the necessary expertise and facilities to bring this Phase I project to a successful conclusion within 9 months. Our strategy is to collaborate with one or more equipment manufacturer which is necessary to effectively expand into the healthcare market (letters Bruker, Medtronic, Thermo, Waters).

对于检测例如早期的传染病，药物 药物过量以及其他与健康相关的测试需求。那是由于缺乏而存在的大量商业机会 这些能力在当前大流行中痛苦​​地“证明”。质谱（MS），因为它的能力 在一次采集中检测数百种甚至数千种生物化合物提供了区分的能力 化学差异与不同的病原体和疾病状态以及靶向特定化合物相关的化学差异 体液。当前的MS方法使用需要用户专业知识并经常专业化的电离方法 仪器，大大增加了成本。在过去的30年中，质谱仪经历了A 复兴的成本实现比率。对于MS在进行医疗保健方面的更多宽度应用程序，有一个 需要新的高级离子源技术，可提供最少的用户干预和长期使用而没有 维护。如果每天每天进行数千个人来识别，跟踪， 并包含传染病的传播，将来将使用MS实施。这个NIH SBIR阶段的目标 我的项目是要证明，一个全新的离子源概念构成了一种破坏性的技术和有效的方法 可以用于下一代疾病测试测量。该提案的基本事故由 MSTM专利申请（＃20210343518，2021年3月31日），以及更早的IP独家许可给MSTM 应用于广泛可用的大气压力电离质谱仪，包括便携式和超高 表现。关键优势包括特殊的易用性，对仪器污染和结转的鲁棒性， 高通量，低成本和使用大多数商业质谱仪进行改造的能力，以提供快速， 敏感和准确的数据按需数据。这个阶段我项目的目的是证明这一点的可行性 通过构建手动双真空电离源的技术 通过机器学习算法的操作和疾病识别。建立一个的具体目的 潜在的破坏性医疗保健技术：目标1：构建能够自动化的手册VMAI/MALDI来源 （最小可行产品）。目标2：证明高灵敏度，可重复性，鲁棒性，分析速度以及 易用性，定量，准确质量，MS/MS和病原体的指纹分析。 MSTM有必要的 在9个月内将该I阶段项目成功得出的专业知识和设施。我们的策略是合作 有一个或多个设备制造商有效地扩展到医疗市场（信件） Bruker，Medtronic，Thermo，Waters）。