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).

迫切需要用于在早期阶段检测例如传染病的快速且具有成本效益的手段， 过量服用，以及其他与健康相关的测试必要性。因此，由于缺乏 这些能力在当前的流行病中痛苦地“展示”出来。质谱法（MS），由于其能够 在一次采集中检测数百甚至数千种生物化合物提供了区分 化学差异与，例如，不同的病原体和疾病状态，以及目标特定的化合物， 体液目前的MS方法使用电离方法，需要用户的专业知识和经常专业化的 仪器，这显著增加了成本。在过去的30年里，质谱仪经历了一个 成本能力比的复兴。对于MS在推进医疗保健方面的更广泛应用， 需要新的先进离子源技术，提供最小的用户干预和长期使用， 上维护如果每个仪器每天测试数千个个体，则这些属性是必要的，例如，识别、跟踪 并控制传染病的传播是在未来使用MS来实现的。NIH SBIR阶段的目标是 我的项目是证明一个全新的离子源概念构成了一个颠覆性的技术和有效的方法 可用于下一代疾病测试测量。本提案的基本发明由 MSTM专利申请（#20210343518，2021年3月31日），和早期的IP独家授权给MSTM，可以 适用于广泛使用的大气压电离质谱仪，包括便携式和超高 性能关键的优点包括非常容易使用，对仪器污染和携带的鲁棒性， 高通量、低成本，以及用大多数商用质谱仪改装以提供快速， 敏感和准确的数据。第一阶段项目的目标是证明这一点的可行性， 技术，通过构建手动双真空电离源，可以在第二阶段自动化， 通过机器学习算法进行手术和疾病识别。具体目标是建立 具有潜在颠覆性的医疗保健技术：目标1：构建能够实现未来自动化的手动vMAI/MALDI源 （最小可行产品）。目标2：证明高灵敏度、重现性、稳健性、分析速度以及 易于使用、定量、准确质量、MS/MS和病原体指纹分析。MSTM具有必要的 专业知识和设施，使这个第一阶段的项目在9个月内圆满结束。我们的战略是合作 与一个或多个设备制造商合作，这是有效扩展到医疗保健市场所必需的（信函 Bruker，Medtronic，Thermo，沃茨）。